Asuntos Regulatorios Argentina: junio 2011

martes, 28 de junio de 2011

What's New on the FDA Drugs Site

June 24, 2011

Drug Shortages: Current Drug Shortages: Calcium Gluconate (updated)
Drug Shortages: Current Drug Shortages: Digoxin Injection (updated)
Drug Shortages: Current Drug Shortages: Leuprolide Injection
Drug Shortages: Current Drug Shortages: Mitomycin Powder for Injection
Drug Shortages: Current Drug Shortages: Phenylephrine HCl Injection (updated)
Drug Shortages: Resolved Drug Shortages: Erythromycin lactobionate injection
Drug Shortages: Resolved Drug Shortages: Tamiflu for Oral Suspension
Drug Shortages: Resolved Drug Shortages: Thyroid (desiccated) tablets
Drug Shortages: Resolved Drug Shortages: Tromethamine
FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. (updated)
New and Generic Drug Approvals

June 24, 2011

Caprelsa (vandetanib) Tablets, AstraZeneca Pharmaceuticals, Labeling Revision
Istodax (romidepsin) I.V. Powder, Celgene Corporation, New or Modified Indication
Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca LP, Labeling Revision
Nexium (esomeprazole magnesium) Delayed-Release Capsules, AstraZeneca LP, Labeling Revision
Nexium (esomeprazole magnesium) Delayed-Release Oral Suspension, AstraZeneca LP, Labeling Revision
Nexium (esomeprazole sodium) Intravenous Injection, AstraZeneca LP, Labeling Revision
Nulojix (belatacept) Injection, Bristol-Myers Squibb Company, Approval
Renagel (sevelamer hydrochloride) Tablets, Genzyme Corporation, Labeling Revision
Sumatriptan Succinate Subcutaneous Injection, Sun Pharmaceutical Industries, Inc., Approval
Symbyax (olanzapine and fluoxetine hydrochloride) Capsules, Eli Lilly and Company, Labeling Revision
Tribenzor (olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide) Tablets, Daiichi Sankyo, Inc., Labeling Revision
Zyprexa (olanzapine) Tablets, Eli Lilly and Company, Labeling Revision
Zyprexa Zydis (olanzapine) Orally Disintegrating Tablets, Eli Lilly and Company, Labeling Revision

What's New on the FDA Drugs Site

FDA MedWATCH

Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations

Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp)

AUDIENCE: Nephrology, Oncology

ISSUE: FDA notified healthcare professionals that new, modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) have been approved to improve the safe use of these drugs. FDA has made these recommendations because of data showing increased risks of cardiovascular events with ESAs in this patient population. The new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke.

BACKGROUND: ESAs treat certain types of anemia by stimulating the bone marrow to produce red blood cells and by decreasing the need for blood transfusions. The manufacturer has revised the Boxed Warning, Warnings and Precautions, and Dosage and Administration sections of the labels for the ESAs to include this new information.

RECOMMENDATION: Healthcare professionals should weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions in CKD patients against the increased risks for serious cardiovascular events, and should inform their patients of the current understanding of potential risks and benefits. Therapy should be individualized to the patient and the lowest possible ESA dose given to reduce the need for transfusions. See the Drug Safety Communication for additional information including a table of key trials and other supporting references. Treatment with ESAs in CKD was discussed at the Drug Safety and Risk Management Advisory Committee, held October 18, 2010. For summary minutes of that Advisory Committee, see link below.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Drug Safety Communication, Press Release, and other information, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm260641.htm

FDA MedWATCH

What is new in FDA

June 23, 2011

Bad Ad Looks Good in Year One (podcast)
CDER Drug and Biologic Approvals for Calendar Year 2010
CDER New Molecular Entity (NME) Drug and New Biologic Approvals in 2009 (updated)
Drugs@FDA Download File (updated)
Drug Firm Annual Registration Status (updated)
Guidance for Industry: Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions: Annex 7(R2) Dissolution Test General Chapter (PDF - 102KB)
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
New and Generic Drug Approvals

June 23, 2011

Busulfex (busulfan) Injection, Otsuka Pharmaceutical Development & Commercialization, Inc., Labeling Revision
Celontin (methsuximide) Capsules, Pfizer, Inc., Labeling Revision
Clobetasol Propionate Topical Spray, Paddock Laboratories, Inc., Approval
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules, Watson Laboratories, Labeling Revision
Invega Sustenna (paliperidone palmitate) Extended-Release Injectable Suspension, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
Kenalog-10 (triamcinolone acetonide) Injection, Bristol-Meyers Squibb, Labeling Revision
Kenalog-40 (triamcinolone acetonide) Injection, Bristol-Meyers Squibb, Labeling Revision
Livalo (pitavastatin calcium) Tablets, Kowa Company Limited, Labeling Revision
Niravam (alprazolam) Orally Disintegrating Tablets, UCB, Inc., Labeling Revision
Prilosec OTC (omeprazole magnesium) Delayed-Release Tablets, AstraZeneca LP, Manufacturing Supplement
Renvela (sevelamer carbonate) Oral Suspension, Genzyme Corporation, Labeling Revision
Renvela (sevelamer carbonate) Tablets, Genzyme Corporation, Labeling Revision
Sucraid (sacrosidase) Oral Solution, QOL Medical LLC, Labeling Revision
Talacen (pentazocine hydrochloride, and acetaminophen) Tablets, Sanofi Aventis, Labeling Revision
Thallous Chloride Tl 201 Injection, Mallinckrodt Inc., Labeling Revision
Torisel (temsirolimus) I.V. Solution, Pfizer Inc., Labeling Revision
Trimethoprim Tablets, Novel Laboratories, Inc., Approval
Ultracet (tramadol hydrochloride and acetaminophen) Tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Labeling Revision
Venofer (iron sucrose) Injection, Luitpold Pharmaceuticals, Inc., Labeling Revision
Zarontin (ethosuximide) Capsules, Pfizer, Inc., Labeling Revision
Zenpep (pancrelipase) Delayed-Release Capsules, Eurand Pharmaceuticals, Inc., Manufacturing Supplement

What is new in FDA

viernes, 24 de junio de 2011

What's New on the FDA Drugs Site

June 22, 2011

Drug Shortages: Current Drug Shortages: Potassium Phosphate Injection9 (updated)
June 21, 2011

Drug Shortages: Current Drug Shortages: Cyanocobalamin injection, 1000 mcg/mL, 1 mL vial (NDC 63323-0044-01)10

Drug Shortages: Current Drug Shortages: Cyanocobalamin injection, 1000 mcg/mL, 1 mL vial (NDC 00517-0031-25), 1000 mcg/mL, 10 mL vial (NDC 00517-0032-25)
11

Drug Shortages: Current Drug Shortages: Thiotepa for Injection12 (updated)

Drug Shortages: Current Drug Shortages: Levorphanol 2mg Tablets13 (updated)

Drug Shortages: Resolved Drug Shortages: Fentanyl Transdermal System14

FDA approves first generic versions of the antibiotic levofloxacin to treat certain infections15

Guidance for Industry: Topical Acne Drug Products for Over-the-Counter Human Use--Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective (PDF - 123KB)16
June 20, 2011

Drug Shortages: Current Drug Shortages: Amikacin Injection17 (updated)
Drug Shortages: Current Drug Shortages: Bleomycin injection18 (updated)
Drug Shortages: Current Drug Shortages: Calcitriol injection19 (updated)
Drug Shortages: Current Drug Shortages: Leucovorin Calcium Lyophilized Powder for Injection20 (updated)

Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs21

FDA Notification to Industry Regarding Potential Adulteration of Pharmaceutical Ingredients used as Emulsifying Agents and Flavorings22

MedWatch Safety Alert: Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor

What's New on the FDA Drugs Site

ANMAT RETIRO DEL MERCADO DE UN LOTE DEL ANTIBIÓTICO URATINA

La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
(ANMAT) informa que la firma Laboratorio Prieto S.A se encuentra procediendo
al retiro del mercado de un lote de la siguiente especialidad medicinal utilizada
como antibiótico:
“URATINA / NITROFURANTOÍNA 5 mg/ml - suspensión oral, lote Nº
00282, con fecha de vencimiento 08/12”
La medida fue adoptada luego de una investigación realizada por la ANMAT, a
partir de un reporte recibido por el Sistema Nacional de Farmacovigilancia.
Mediante los análisis realizados, se determinó que la partida en cuestión no
cumple con el ensayo de simulación de uso, según las instrucciones del
prospecto, debido a que la elevada consistencia del producto impide su
correcta dosificación.
Por lo expuesto, esta Administración Nacional se encuentra controlando el
retiro del mercado por parte del laboratorio, y recomienda a la población que
se abstenga de utilizar las unidades correspondientes al lote detallado.

ANMAT RETIRO DEL MERCADO DE UN LOTE DEL ANTIBIÓTICO URATINA

RETIRO DEL MERCADO DE UN LOTE DEL ANTIBIÓTICO URATINA
La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
(ANMAT) informa que la firma Laboratorio Prieto S.A se encuentra procediendo
al retiro del mercado de un lote de la siguiente especialidad medicinal utilizada
como antibiótico:
“URATINA / NITROFURANTOÍNA 5 mg/ml - suspensión oral, lote Nº
00282, con fecha de vencimiento 08/12”
La medida fue adoptada luego de una investigación realizada por la ANMAT, a
partir de un reporte recibido por el Sistema Nacional de Farmacovigilancia.
Mediante los análisis realizados, se determinó que la partida en cuestión no
cumple con el ensayo de simulación de uso, según las instrucciones del
prospecto, debido a que la elevada consistencia del producto impide su
correcta dosificación.
Por lo expuesto, esta Administración Nacional se encuentra controlando el
retiro del mercado por parte del laboratorio, y recomienda a la población que
se abstenga de utilizar las unidades correspondientes al lote detallado.

miércoles, 22 de junio de 2011

FDA MedWATCH

Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor

AUDIENCE: Pharmacy, Psychiatry, Neurology, Internal Medicine

ISSUE: Ortho-McNeil-Janssen Pharmaceuticals notified healthcare professionals and the public of a recall of specific lots of Risperdal (risperidone) 3mg tablets and risperidone 2mg tablets. The recall stems from consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which materials are transported and stored. While not considered to be toxic, TBA can generate an offensive odor and a small number of patients have reported temporary gastrointestinal symptoms.

BACKGROUND: The Risperdal lot 0GG904 - which includes approximately 16,000 bottles - was shipped between 8/27/2010 and 2/15/2011. The company believes there are approximately 1,600 bottles of Risperdal from this lot remaining in the marketplace. The risperidone lot OIG175 - which includes approximately 24,000 bottles - was shipped between 11/10/2010 and 1/01/2011. The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace. Risperdal (risperidone) is used for the treatment of schizophrenia in adults and adolescents ages 13-17 years, alone or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10-17 years for the short-term treatment of bipolar mania and is used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5-16 years.

RECOMMENDATION: Patients should not stop taking their medication. Anyone experiencing an uncharacteristic odor associated with Risperdal 3mg Tablets or risperidone 2mg Tablets should return the tablets to their pharmacist, and contact their healthcare professional if they have questions.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259901.htm

MedWATCH

Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy

AUDIENCE: Interventional Radiology, Risk Manager

ISSUE: Complaints of no deployment and partial deployment have been received. This type of failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent. This recall does not affect stents that have already been implanted as the issue occurs during delivery of the stent.

BACKGROUND: The Innova Stent System is intended for use in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery.

RECOMMENDATION: Boston Scientific sent an urgent medical device recall letter to OUS customers on May 13, 2011. The recall notice explained the issue, identified the affected products, required distributors to cease further distribution and use of the product, and requested the return of unused product to Boston Scientific. See the Recall Notice for a complete list of affected lot numbers.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259764.htm

ANMAT Farmacopea Argentina 8ª Edición

La “Farmacopea Argentina” o “Codex Medicamentarius Argentino” es el
código oficial donde se describen las drogas, medicamentos y productos
médicos necesarios o útiles para el ejercicio de la medicina y la farmacia,
especificando lo concerniente al origen, preparación, identificación, pureza,
valoración y demás condiciones que aseguran la uniformidad y calidad de
las propiedades de los mismos.
Es de uso obligatorio para todas las farmacias, droguerías, empresas
elaboradoras e importadoras y establecimientos comercializadores y/o
distribuidores de drogas y medicamentos, como también de productos
médicos que por sus características deban responder a especificaciones de
la Farmacopea Argentina
Presentamos, para el conocimiento público, el texto de la Farmacopea
Argentina 8ª edición, el cual se encuentra en proceso de sanción por
parte del Congreso de la Nación.

ANMAT GUÍA DEL USUARIO PARA SOLICITANTES DE CERTIFICADOS DE FIRMA DIGITAL

Mediante la Disposición Nº 4029/11, la ANMAT aprobó la “Guía del Usuario” para
los solicitantes de certificados de firma digital que realicen trámites ante esta
Administración Nacional.
La firma digital es una herramienta tecnológica que garantiza la autoría e integridad
de los documentos digitales, al posibilitar que éstos posean la misma característica
que la firma hológrafa (de puño y letra) exclusiva de los documentos en papel.
Constituye un pilar fundamental del desarrollo de la gestión de gobierno
electrónico.
También es posible definirla como un conjunto de datos electrónicos inviolables
asociados a un mensaje digital, que permite garantizar la integridad del mismo y la
identidad del firmante.
Esta herramienta asegura la autenticidad del mensaje, ya que permite que terceras
partes puedan reconocer la identidad del firmante y asegurarse que los contenidos
no han sido modificados. Todo ello brinda seguridad en el intercambio de
información crítica, permite reemplazar a la documentación en papel, reduce costos
generales, otorga mayor velocidad de procesamiento y mejora la calidad de
servicio.

viernes, 17 de junio de 2011

FDA MedWATCH

Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events

AUDIENCE: Family Medicine, Cardiology

ISSUE: FDA notified healthcare professionals and patients that the Prescribing Information for this drug product will be strengthened to inform the public that use of varenicline may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section and the patient Medication Guide.

BACKGROUND: FDA reviewed a randomized, double-blind, placebo-controlled clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo. While cardiovascular adverse events were infrequent overall, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo. The events included angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease. FDA is continuing to evaluate the cardiovascular safety of Chantix and is requiring the manufacturer to conduct a large, combined analysis (meta-analysis) of randomized, placebo-controlled trials. FDA will update the public when additional information is available.

RECOMMENDATION: See the Data Summary section of the Drug Safety Communication for additional information.

Healthcare professionals should be aware that smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease.

Patients are encouraged to read the Medication Guide they receive along with their Chantix prescription.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259469.htm

What's New on the FDA Drugs Site

June 15, 2011

Drug Shortages: Current Drug Shortages: Etoposide solution for injection (updated)
Drugs@FDA Download File (updated)
FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
National Drug Code Directory (updated)
New and Generic Drug Approvals

June 15, 2011

Alkeran (melphalan hydrochloride) Injection, GlaxcoSmithKline, Labeling Revision
Alkeran (melphalan) Tablets, GlaxcoSmithKline, Labeling Revision
Bupropion Hydrochloride Extended-Release Tablets, Anchen Pharmaceuticals, Inc., Approval
Bupropion Hydrochloride Extended-release Tablets (150mg), Anchen Pharmaceuticals, Inc., Approval
Cipro (ciprofloxacin hydrochloride) Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
Cipro (ciprofloxacin) Oral Suspension, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
Cipro XR (ciprofloxacin) Extended-Release Tablets, Bayer HealthCare Pharmaceuticals, Inc., Labeling Revision
Clolar (clofarabine) I.V. Injection, Genzyme Corp., Labeling Revision
Creon (pancrelipase) Delayed-Release Capsules, Abbott Products Inc., Manufacturing Supplement
Doxycycline Hyclate Delayed-Release Tablets, Mylan Pharmaceuticals Inc., Tentative Approval
Potiga (ezogabine) Tablets, Valeant Pharmaceuticals, Approval
Zenpep (pancrelipase) Delayed-Release Capsules, Eurand Pharmaceuticals, Inc., Labeling Revision

FDA MedWATCH

Indomethacin for Injection: Recall of One Lot - Particulate Matter

AUDIENCE: Risk Manager, Pharmacy

ISSUE: Bedford Laboratories, a division of Ben Venue Laboratories, Inc., initiated a nationwide voluntary recall of Indomethacin for Injection, USP, 1mg Single Dose Vial (NDC #55390-299-01, Lot 1948138, Exp. Date September 2011) as it may contain particulate matter. The particulate matter has been identified as active drug substance and not foreign material or contamination. FDA states that particulate matter may provoke an immune reaction and/or lead to microinfarcts which could be serious and life threatening.
BACKGROUND: Indomethacin for injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants, who typically have small blood vessels.
RECOMMENDATION: Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers should not use Bedford Laboratories’ Indomethacin Injection, USP 1mg Vials, with Lot 1948138, for patient care and should immediately quarantine any product for return.
Those with questions about the return or recall process, please call the Bedford Customer Service Department at 1.800.562.4797.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
For more information please see the MedWatch Alert.

ANMAT ALERTA SOBRE LOTE DE SOLUCIÓN DE DEXTROSA APÓCRIFA

La Administración Nacional de Medicamentos, Alimentos y Tecnología
Médica (ANMAT) alerta a la población sobre la presencia en el mercado
nacional de un lote apócrifo de solución de dextrosa, cuyos datos son los
siguientes:
SOLUCION DE DEXTROSA al 5% por 500 ml - LAB. RIGECIN, con
codificación de lote ilegible y fecha de vto. 12/2012.
La detección de esta partida se realizó a través del Programa Nacional de
Control de Mercado de Medicamentos y Productos Médicos, dependiente de
esta Administración.
La firma RIGECIN LABS S.A.C.I.F.I., titular de la marca registrada de la
especialidad medicinal en cuestión, manifestó que el lote detallado no es
original del laboratorio, tratándose por lo tanto de un producto apócrifo.
Por todo lo expuesto, se recomienda a la población que se abstenga de
adquirir o utilizar la partida mencionada. Además, esta Administración
comunicará el hallazgo a los organismos competentes y formulará la
correspondiente denuncia en el ámbito judicial

ANMAT RETIRO DEL MERCADO DE UN LOTE DEL PRODUCTO HYALOMB

La Administración Nacional de Medicamentos, Alimentos y Tecnología
Médica (ANMAT) informa a la población que está procediendo al retiro del
mercado de un lote del siguiente producto:
“HYALOMB – Ácido Hialurónico (sal sódica) - SOLUCIÓN OFTÁLMICA
ESTÉRIL, 10 ml, lote V 27 con fecha de vencimiento 03/13”, cuyo
titular de registro es la firma “Laboratorio Bausch & Lomb Argentina S.R.L.”
El lote mencionado contiene en su interior un envase (frasco gotero)
etiquetado incorrectamente con la leyenda “PANOPTIC NF FRESH –
Nafazolina Clorhidrato - SOLUCIÓN OFTÁLMICA, 10 ml”, con igual número
de lote y fecha de vencimiento.
Las medidas adoptadas en relación al producto detallado se motivan en una
investigación realizada por la ANMAT, a partir de una denuncia comunicada
por el Ministerio de Salud de la provincia de Mendoza. Luego de realizar las
verificaciones pertinentes, esta Administración Nacional corroboró que, si
bien el contenido del frasco gotero corresponde al producto “Hyalomb”, el
mismo fue etiquetado incorrectamente. Dicho error se repite en varias
unidades de ese mismo lote.
Por todo lo expuesto, la ANMAT solicita a la población que se abstenga del
uso de la partida en cuestión.

ANMAT GUIA PARA SOLICITAR FIRMA DIGITAL

GUÍA DEL USUARIO PARA SOLICITANTES DE
CERTIFICADOS DE FIRMA DIGITAL
Mediante la Disposición Nº 4029/11, la ANMAT aprobó la “Guía del Usuario” para
los solicitantes de certificados de firma digital que realicen trámites ante esta
Administración Nacional.
La firma digital es una herramienta tecnológica que garantiza la autoría e integridad
de los documentos digitales, al posibilitar que éstos posean la misma característica
que la firma hológrafa (de puño y letra) exclusiva de los documentos en papel.
Constituye un pilar fundamental del desarrollo de la gestión de gobierno
electrónico.
También es posible definirla como un conjunto de datos electrónicos inviolables
asociados a un mensaje digital, que permite garantizar la integridad del mismo y la
identidad del firmante.
Esta herramienta asegura la autenticidad del mensaje, ya que permite que terceras
partes puedan reconocer la identidad del firmante y asegurarse que los contenidos
no han sido modificados. Todo ello brinda seguridad en el intercambio de
información crítica, permite reemplazar a la documentación en papel, reduce costos
generales, otorga mayor velocidad de procesamiento y mejora la calidad de
servicio.

miércoles, 15 de junio de 2011

What's New on the FDA Drugs Site

What's New on the FDA Drugs Site

June 14, 2011

Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Cleviprex (updated)
FDA Drug Safety Podcast for Healthcare Professionals: Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)
Guidance for Industry: Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application (PDF - 133KB)
Sunscreen: FDA Announces Changes to Better Inform Consumers About Sunscreen
Questions and Answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S.
New and Generic Drug Approvals

June 14, 2011

Nabumetone Tablets, Watson Laboratories, Inc., Approval
Ranitidine Hydrochloride Syrup, Taro Pharmaceuticals U.S.A., Inc., Approval

What's New on the FDA Drugs Site

FDA MedWATCH

The MedWatch May 2011 Safety Labeling Changes posting includes 47 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The "Summary Page" provides a listing of drug names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm258300.htm

Clicking on a drug product name in the Summary View will take you to the "detailed view" page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information.

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and WARNINGS sections:

Aciphex (rabeprazole sodium) Delayed-Release Tablets
Afinitor (everolimus) Tablets
Aldactazide (spironolactone/hydrochlorothiazide) Tablets
Avandia (rosiglitazone maleate)
Avandamet (rosiglitazone maleate/metformin hydrochloride)
Avandaryl (rosiglitazone maleate/glimepiride) Tablets
Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) Tablets
Biaxin Filmtab (clarithromycin tablets, USP) Biaxin XL Filmtab (clarithromycin extended-release tablets),Biaxin Granules (clarithromycin for oral suspension, USP)
Dexilant (dexlansoprazole) Delayed Release Capsules
Genotropin (somatropin [rDNA origin] for Injection
Humalog (insulin lispro [rDNA origin]) Injection
Imuran (azathioprine) Tablets and Injection
Levatol (penbutolol sulfate) Tablets
Micardis HCT (telmisartan/hydrochlorothiazide) Tablets
Norditropin Cartridges (somatropin [rDNA origin] injection)
Omeprazole / Sodium Bicarbonate / Magnesium Hydroxide Tablets
Prevacid(Lansoprazole) Delayed-Release Capsules
Prevacid SoluTab (Lansoprazole) Delayed-Release Orally Disintegrating Tablets
Prilosec (omeprazole) Delayed Release Capsules and Prilosec (omeprazole magnesium) For Delayed Release Oral Suspension
Protonix (pantoprazole sodium) For Delayed-Release Oral Suspension 40 mg and Protonix (pantoprazole sodium) Delayed-Release Tablets, Protonix I.V. (pantoprazole sodium) for Injection
Purinethol (mercaptopurine) Tablets
Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate) Extended-ReleaseTablets
Sutent (sunitinib malate) Capsules
Teveten HCT (eprosartan mesylate/hydrochlorothiazide) Tablets
Uniretic (moexipril hydrochloride/hydrochlorothiazide)
Vimovo (naproxen/esomeprazole magnesium) Tablets
Zegerid (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension
Ziac (bisoprolol fumarate/hydrochlorothiazide) Tablets

FDA MedWATCH

Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient

AUDIENCE: Cardiology, Surgery

ISSUE: The catheter tip can break inside of the patient and embolize causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery.

BACKGROUND: The Boston Scientific iCross and Atlantis A SR Pro2 coronary imaging catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is used on patients who are candidates for transluminal coronary interventional procedures.

RECOMMENDATION: Boston Scientific Corporation notified customers by letter on May 27, 2011 describing the problem, the potential hazard, and the action to be taken. Customers were instructed to discontinue use and return all products to Boston Science.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259097.htm

FDA MedWATCH

Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize

AUDIENCE: Cardiology, Surgery

ISSUE: Foreign fragments of adhesive and plastic in the cannula tip may embolize causing arterial injury, hemorrhaging or other serious events requiring unplanned surgery. Terumo Cardiovascular Systems Corporation (Terumo CVS) decided to remove the product line from the market and discontinue further supply.

BACKGROUND: The Terumo Coronary Ostia Cannula is indicated for use in delivering cardioplegia solution directly to the coronary arteries during cardiopulmonary bypass.

RECOMMENDATION: Terumo is advising customers to immediately discontinue use of any affected product and return all products in inventory.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259082.htm

FDA MedWATCH

Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning

AUDIENCE: Cardiology, Surgery

ISSUE: A defective fan in the power supply may cause overheating and shut down the device without visible or audible alarms. Consequences of unanticipated interruption of therapy may include the inability to decrease already-present ischemia, thrombus formation, organ injury or other serious events.

BACKGROUND: The intra-aortic balloon pump is an electromechanical system used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle of the heart during cardiac surgery. See the recall notice for the affected lot/serial numbers of the devices are subject to this recall.

RECOMMENDATION: Maquet Datascope Corporation notified customers by letter on March 17, 2011 describing the problem, the potential hazard, and the action to be taken. Customers were advised that their Service Representative would arrange to replace the power supply on affected devices which would contain a new fan assembly.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Class I recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259078.htm

FDA MedWATCH

What's New on the FDA Drugs Site

What's New on the FDA Drugs Site

June 13, 2011

Bad Ad Program: 2010-2011 Year End Report
Dissolution Methods Search (updated)
Drug Firm Annual Registration Status (updated)
Drug Shortages: Resolved Drug Shortages: Nitroglycerin in Dextrose 5%
FDA approves Potiga (ezogabine) to treat seizures in adults
FDA Drug Safety Communication: Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)
MedWatch Safety Alert: Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis
New and Generic Drug Approvals

June 13, 2011

Erythrocin ( erythromycin lactobionate) Injection, Hospira, Inc., Labeling Revision
Levaquin (levofloxacin) Tablets, Ortho-McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
Levaquin (levofloxacin) Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
Levaquin in Dextrose 5% in plastic container (levofloxacin) Injection, Ortho-McNeil-Janssen Pharmaceutical, Inc., Labeling Revision
Levaquin (levofloxacin) Oral Solution, Ortho-McNeil-Janssen Pharmaceutical, Inc., Labeling Revision

What's New on the FDA Drugs Site

FDA MedWATCH

Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors - Name Confusion

AUDIENCE: Pharmacy, Psychiatry, Neurology, Internal Medicine

ISSUE: FDA notified healthcare professionals and the public of medication error reports in which patients were given risperidone (Risperdal) instead of ropinirole (Requip) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.

The FDA determined that the factors contributing to the confusion between the two products include:

Similarities of both the brand (proprietary) and generic (established) names
Similarities of the container labels and carton packaging
Illegible handwriting on prescriptions
Overlapping product characteristics, such as the drug strengths, dosage forms, and dosing intervals.
BACKGROUND: Risperidone (Risperdal) is an antipsychotic medication used to treat mental illnesses including schizophrenia, bipolar disorder, and irritability associated with autistic disorder. Ropinirole (Requip) is a dopamine agonist used in the treatment of Parkinson’s disease and Restless Legs Syndrome.

RECOMMENDATION: Healthcare Professionals are reminded to clearly print or spell out the medication name on prescriptions and make certain their patients know the name of their prescribed medication and their reason for taking it.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258905.htm

FDA MedWATCH

What's New on the FDA Drugs Site

June 10, 2011

Approved Risk Evaluation and Mitigation Strategies (REMS) (updated)
Best Pharmaceuticals for Children Act of 2007: List of Determinations Including Written Request (updated)
Drug Shortages: Current Drug Shortages: Amphetamine Mixed Salts, ER Capsules (updated)
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Cytarabine Injection (updated)
Drug Shortages: Current Drug Shortages: Dexamethasone Injection (updated)
Drug Shortages: Current Drug Shortages: Etoposide solution for injection (updated)
Drug Shortages: Current Drug Shortages: Leucovorin Calcium Lyophilized Powder for Injection (updated)
Drug Shortages: Current Drug Shortages: Neostigmine methylsulfate injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 23.4%(updated)
FDA approves redesigned labels for some Merck drugs
FDA Drug Safety Podcast for Healthcare Professionals: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
Paragraph IV Patent Certifications (updated)
New and Generic Drug Approvals

June 10, 2011

Avodart (dutasteride) Capsules, GlaxoSmithKline, Efficacy Supplement with Clinical Data to Support
Avodart (dutasteride) Capsules, GlaxoSmithKline, Labeling Revision
Docetaxel Injection, Accord Healthcare, Inc., Approval
Estradiol and Norethindrone Acetate Tablets, Breckenridge Pharmaceutical, Inc., Chemistry New Strength
Intuniv (guanfacine hydrochloride) Extended-Release Tablets, Shire Development, Inc., Labeling Revision
Jalyn (dutasteride and tamsulosin hydrochloride) Capsules, GlaxoSmithKline, Labeling
Revision
Mifeprex (mifepristone) Tablets, Danco Laboratories, LLC, Labeling Revision
Mupirocin Ointment, Glenmark Generics, Ltd., Approval
PerioChip (chlorhexidine gluconate) Dental Tablets, Dexcel Pharma Technologies, Ltd., Labeling Revision
Propecia (finasteride) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
Proscar (finasteride) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
Ramipril Capsules, Aurobindo Pharma, Ltd., Approval
Simcor (niacin and simvastatin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision
Vytorin (ezetimibe and simvastatin) Tablets, MSP Singapore Co., LLC, Labeling Revision
Zocor (simvastatin) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
Zutripro (hydrocodone, chlorpheniramine and pseudoephedrine) Oral Solution, Cypress Pharmaceuticals, Approval

What's New on the FDA Drugs Site

FDA MedWATCH

Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis

AUDIENCE: Endocrinology, Family Practice

ISSUE: Novo Nordisk reminded healthcare professionals of important safety information about Victoza (liraglutide [rDNA origin]) injection required in a Risk Evaluation and Mitigation Strategy (REMS). The letter is being sent because a recent assessment of healthcare providers showed that some primary care providers are not fully aware of the serious risks associated with the use of Victoza.

Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Victoza causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Additionally, in clinical trials studying Victoza, there were more cases of pancreatitis in patients treated with Victoza than in patients treated with comparators.

BACKGROUND: FDA may require a REMS for newly or already approved prescription drug product when FDA determines that a REMS is necessary to ensure the benefits of a drug outweigh the risks of the drug. Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

RECOMMENDATION: Patients with thyroid nodules noted on physical examination or neck imaging obtained for other reasons should be referred to an endocrinologist for further evaluation. Although routine monitoring of serum calcitonin is of uncertain value in patients treated with Victoza, if serum calcitonin is measured and found to be elevated, the patient should be referred to an endocrinologist for further evaluation.

After initiation of Victoza, and after dose increases, observe patients carefully for signs and symptoms of pancreatitis (including persistent severe abdominal pain, sometimes radiating to the back, and which may or may not be accompanied by vomiting).

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Dear Healthcare Professional Letter, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258826.htm

FDA MedWATCH

lunes, 13 de junio de 2011

What's New on the FDA Drugs Site

June 9, 2011

Drug Safety Oversight Board Meeting, May 19, 2011, Public Summary
FDA Drug Safety Communication: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
Questions and Answers: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer
FDA Drug Safety Podcast for Healthcare Professionals: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
Medication Guides (updated)
New and Generic Drug Approvals

June 9, 2011

Heparin Sodium Injection, Sandoz Inc., Approval
Heparin Sodium Injection, Sandoz Inc., Approval
Heparin Sodium Injection, Sandoz Inc., Approval
Lopinavir and Ritonavir Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
Mycamine (micafungin sodium) Injection, Astellas Pharma US, Inc., Labeling Revision
Zmax (azithromycin) Extended-Release Oral Suspension, Pfizer Global Research and Development, Labeling Revision

viernes, 10 de junio de 2011

MedWATCH

5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer

Drugs in the 5-ARI class include finasteride and dutasteride. These drugs are marketed under the brand-names Proscar, Propecia, Avodart, and Jalyn

AUDIENCE: Urology, Family Medicine, Internal Medicine

ISSUE: FDA notified healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).

BACKGROUND: The new safety information is based on FDA’s review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Proscar, Avodart, and Jalyn are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate. Propecia is approved to treat male pattern hair loss.

RECOMMENDATION: Prior to initiating therapy with 5-ARIs, perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH). See Drug Safety Communication for a Data Summary and additional information.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258529.htm

MedWATCH

What is new in FDA

June 8, 2011

Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Amino Acid Injection (updated)
Drugs@FDA Download File (updated)
FDA Drug Safety Communication: New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce the risk of muscle injury
Guidance for Industry: Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act (PDF - 115KB)
New and Generic Drug Approvals

June 8, 2011

Alprazolam Extended-Release Tablets, Aurobindo Pharma Ltd., Approval
Cleocin Hydrochloride (clindamycin hydrochloride) Capsules, Pfizer, Inc., Labeling Revision
Cleocin Phosphate (clindamycin phosphate) Injection, Pfizer, Inc., Labeling Revision
Cleocin Phosphate in Dextrose 5% in Plastc Container (clindamycin phosphate) Injection, Pfizer, Inc., Labeling Revision
Clobetaso Propionate Shampoo, Actavis Mid Atlantic LLC, Approval
Dilacor XR (diltiazem hydrochloride) Extended Release Capsules, Watson Laboratories, Inc., Labeling Revision
Isosorbide Mononitrate Extended-Release Tablets, Torrent Pharmaceuticals Ltd., Approval
Letrozole Tablets, Indicus Pharma LLC., Approval
Protonix IV (pantoprazole sodium) I.V. Injection, Wyeth Pharmaceuticals Inc., Labeling Revision
Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Labeling Revision
Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
Salonpas (menthol and methyl salicylate) Patch, Hisamitu Pharmaceutical Co., Inc., Labeling Revision
Temodar (temozolomide) Capsules, Schering Corporation, Labeling Revision
Temodar (temozolomide) Injection, Schering Corp., Labeling Revision

What is new in FDA

jueves, 9 de junio de 2011

MedWATCH

Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations

Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor

AUDIENCE: Family Practice, Cardiology, Pharmacy

ISSUE: FDA notified healthcare professionals that it is recommending limiting the use of the highest approved dose of the cholesterol-lowering medication simvastatin (80 mg) because of increased risk of muscle damage. Patients taking simvastatin 80 mg daily have an increased risk of myopathy compared to patients taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a genetic predisposition toward simvastatin-related myopathy. The most serious form of myopathy, called rhabdomyolysis, can damage the kidneys and lead to kidney failure which can be fatal. FDA is requiring changes to the simvastatin label to add new contraindications (should not be used with certain medications) and dose limitations for using simvastatin with certain medicines.

BACKGROUND: The new changes to the drug labels for simvastatin-containing medicines are based on FDA's review of the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine (SEARCH) trial and other data described in the Agency's March 2010 Ongoing safety review of high-dose Zocor (simvastatin) and increased risk of muscle injury. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of muscle injury (myopathy).

RECOMMENDATION: Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the FDA Drug Safety Communication, Press Release, and Consumer Update, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258384.htm

miércoles, 8 de junio de 2011

Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient

AUDIENCE: Emergency Medicine, Pediatrics

ISSUE: Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.

BACKGROUND: The Microstream CO2 Filterline is a medical device used by emergency medical services, hospitals, and other health care providers to measure exhaled carbon dioxide (CO2) during ventilation of newborn and infant patients. See the recall notice for affected models and lots.

RECOMMENDATION: Philips instructed users to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including links to the Class I Recall Notice and press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm258133.htm

What's New on the FDA Drugs Site

June 7, 2011

BPCA/Pediatric Exclusivity Statistics
Pediatric Exclusivity Granted (updated)
Pediatric Exclusivity Statistics (updated)
Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Magnesium Sulfate Injection
Drug Shortages: Current Drug Shortages: Methylphenidate HCl (updated)
MedWatch Safety Alert: American Regent Injectable Products: Recall - Visible Particulates in Products (updated)
National Drug Code Directory (updated)
NDC Product File Definitions (updated)
NDC Package File Definitions (updated)
June 6, 2011

Guidance for Industry: Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 41KB)
New and Generic Drug Approvals

June 7, 2011

Avalide (hydrochlorothiazide and irbesartan) Tablets, Sanofi-Aventis, Labeling Revision
Benicar (olmesartan medoxomil) Tablets, Daiichi Sankyo Inc., Labeling Revision
Corgard (nadolol) Tablets, King Pharmaceuticals Inc., Labeling Revision
Corzide (bendroflumethiazide and nadolol) Tablets, Pfizer, Inc., Labeling Revision
Diflucan in Dextrose 5% in Plastic Container (fluconazole) Injection, Pfizer, Inc., Labeling Revision
Diflucan (fluconazole) Oral Suspension, Pfizer, Inc., Labeling Revision
Diflucan (fluconazole) Tablets, Pfizer, Inc., Labeling Revision
Losartan Potassium Tablets, Huahai US Inc., Approval
Macrobid (nitrofurantoin and macrocrystaline) Capsules, Almatica Pharma, Inc., Labeling Revision
Macrodantin (nitrofurantoin macrocrystals) Capsules, Almatica Pharma, Inc., Labeling Revision
Twynsta (amlodipine besylate and telmisartan) Tablets, Boehringer Ingelheim Pharmaceuticals, Inc., Labeling Revision
Rapamune (sirolimus) Oral Solution, Wyeth Pharmaceuticals, Inc., Approval
Rapamune (sirolimus) Tablets, Wyeth Pharmaceuticals, Inc., Approval
Zolpidem Tartrate Extended-Release Tablets, Actavis South Atlantic LLC, Approval
Zolpidem Tartrate Extended-Release Tablets, Synthon Pharmaceuticals, Inc., Approval
June 6, 2011

Diovan (valsartan) Tablets, Novartis, Labeling Revision
Letrozole Tablets, Synthon Pharmaceuticals, Inc., Approval
Letrozole Tablets, Fresenius Kabi Oncology, Approval
Letrozole Tablets, Endo Pharmaceuticals, Inc., Approval
Letrozole Tablets, Dr. Reddy’s Laboratories Ltd., Approval
Letrozole Tablets, Roxane Laboratories, Inc., Approval
Letrozole Tablets, Natco Pharma Ltd., Approval
Letrozole Tablets, Accord Healthcare, Inc., Approval
Letrozole Tablets, Impax Laboratories, Inc., Approval
Letrozole Tablets, Sun Pharmaceutical Industries Ltd., Approval
Letrozole Tablets, Kudco Ireland Ltd., Approval
Letrozole Tablets, TEVA Pharmaceuticals, Approval

martes, 7 de junio de 2011

What's New on the FDA Drugs Site

June 3, 2011

Drug Firm Annual Registration Status (updated)
Drug Shortages: Current Drug Shortages: Acetylcysteine Inhalation Solution (updated)
Drug Shortages: Current Drug Shortages: Ammonium Chloride Injection (updated)
Drug Shortages: Current Drug Shortages: Bleomycin Injection (updated)
Drug Shortages: Current Drug Shortages: Desmopressin Injection (updated)
Drug Shortages: Current Drug Shortages: Foscarnet Sodium Injection (updated)
Drug Shortages: Current Drug Shortages: Fosphenytoin Sodium Injection (updated)
Drug Shortages: Current Drug Shortages: Furosemide Injection (updated)
Drug Shortages: Current Drug Shortages: Intravenous Fat Emulsion (updated)
Drug Shortages: Current Drug Shortages: Lorazepam Injection (updated)
Drug Shortages: Current Drug Shortages: Metoclopramide injection (updated)
Drug Shortages: Current Drug Shortages: Multi-Vitamin Infusion (Adult and pediatric) (updated)
Drug Shortages: Current Drug Shortages: Procainamide HCL Injection (updated)
Drug Shortages: Current Drug Shortages: Propofol Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 23.4% (updated)
Drug Shortages: Current Drug Shortages: Sodium Chloride 14.6% Injection (updated)
Drug Shortages: Current Drug Shortages: Sodium Phosphate Injection (updated)
Drug Shortages: Current Drug Shortages: Tromethamine (updated)
Drug Shortages: Current Drug Shortages: Vecuronium Injection(updated)
Drug Shortages: Current Drug Shortages: Vincristine Sulfate Injection(updated)
MedWatch Safety Alert: Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products
Office of Translational Sciences (updated)
New and Generic Drug Approvals

June 3, 2011

Banzel (rufinamide) Oral Tablets, Eisai, Inc., Labeling Revision
Banzel (rufinamide) Oral Suspension, Eisai, Inc., Labeling Revision
Clindamycin Hydrochloride Capsules, Matrix Laboratories Ltd., Approval
Diovan HCT (hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Donepezil Hydrochloride Tablets, Apotex Inc., Approval
Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals, Labeling Revision
Exforge HCT (amlodipine besylate, hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
Pepcid (famotidine) Tablets, Merck & Co., Inc., Labeling Revision
Prevacid (lansoprazole) Delayed-Release Capsules, Takeda Pharmaceuticals, Labeling Revision
Prevacid (lansoprazole) Delayed-Release Orally Disintegrating Tablets, Takeda Pharmaceuticals, Labeling Revision
Retisert (fluocinolone acetonide) Implant, Bausch & Lomb, Inc., Manufacturing Change or Addition
Venlafaxine Hydrochloride Extended-Release Capsules, Mylan Pharmaceuticals, Inc., Approval
Venlafaxine Hydrochloride Extended-Release Capsules, Torrent Pharmaceuticals Ltd., Approval
Tussionex Pennkinetic (chlorpheniramine polistirex and hydrocodone polistirex) Extended-Release Oral Suspension, UCB, Inc., Approval

Uppsala Monitoring Centre Newsletter Issue nr 2, June - 2011

The second quarter of 2011 is here and the Uppsala Monitoring Centre’s new Drug Dictionary China will be launched, the upcoming WHO Drug Dictionary User Group Meeting will take place in Brussels, the UMC continues to develop new SDGs and lastly we would like to inform you about the Japanese Cross Reference Tool.

The New Drug Dictionary China – The Code to China

It is now here. The new Drug Dictionary China, which translates Chinese character medicinal product names into the WHO DDE global coding system. This conversion gives you direct access to a collection of up-to-date medicinal product information and analytical tools which is contained within the WHO DDE for drugs used in China; it also includes Traditional Chinese Medicines.
A world premiere for the new Drug Dictionary China is going to be held at the 47th DIA Annual meeting in Chicago, IL on June 19-23, 2011.
Come and meet us in Chicago!
Read more about the new Drug Dictionary China www.CodetoChina.com

The WHO Drug Dictionary User Group Meeting in Europe Brussels

The WHO Drug Dictionary User Group Meeting in Europe will take place in Brussels, on September 15th, 2011.
At the 2010 User Group meetings the groups talked about how the dictionary is used in everyday work – how this can be used as input to the developers of coding software and how we can develop
‘Best Practices’ based on these discussions. Best Practices have now been published as drafts and more are underway. At the User Group meeting in Brussels we will – among other things – develop these practices further with the coded data in mind; from the preparation of a clinical trial to the data collection and coding, data storage, analysis and interpretation.
Sign up at the User Group Portal to take part of what's new and ongoing in the WHO Drug Dictionaries.
Contact us at drugdictionary@umc-products.com to let us know if there are any speakers or topics that you would like to be present at the meeting.

Standardised Drug Groupings (SDGs) – Continues to Develop

In 2010 the first Standardised Drug Groupings were launched – additional classifications and lists that can be used in the preparation of Medication of Interest lists and for the analysis of coded data.
The work continues in 2011 – a new working group will put together new groupings, which will be prioritized and developed.
Please, let us know if you would like to suggest a new SDG or if you want to learn more about the SDGs. We welcome old as well as new members in the SDG Working Group.
Contact us at drugdictionary@umc-products.com if you want to participate – or if you want to know more about how the group is going to develop the new groupings.

Launch of the Japanese Cross Reference Tool

The UMC has together with ‘Ijoken’ - the maintenance organization Iyakuhinmey Data File (IDF) in Japan – created a Cross Reference Tool that will make it easy to find the WHO Drug Dictionary Enhanced code that corresponds to a selected code in the IDF dictionary (in Japanese). This will make it easy and possible to analyze IDF-coded data with the tools included in the WHO Drug Dictionary Enhanced. This tool is now being tested by few Japanese pharmaceutical companies and it will be launched in June, 2011.