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FDA updates for health professionals - 04/11/12

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U.S. Food and Drug Administration 
Office of Special Health Issues 
10903 New Hampshire Avenue 
Silver Spring, Maryland 20993 

Dear Colleague,

As part of our ongoing efforts to keep you informed about FDA issues, we want to make you are aware of recent safety alerts, announcements, opportunities to comment on policy issues, product approvals, upcoming meetings, and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site. 

??PRODUCT SAFETY: 

FDA approved an update to the Postmarketing Experience section of the labeling for finasteride products, Propecia (finasteride 1 mg) and Proscar (finasteride 5 mg). (Apr 11) This update includes sexual adverse events that continued after discontinuation of the drug. Questions and answers about the labeling changes may be found on FDA’s website:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm

Clarification of dosing and warning recommendations for Celexa (Mar 29) 
The FDA is clarifying dosing and warning recommendations for the drug Celexa (citalopram hydrobromide). 

Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clots (Apr 10)

FDA has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.

Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform (Apr 4)
FDA is notifying health care professionals of a Class 1 Recall due to detachment of the bend relief from its intended position around the proximal outflow graft may allow the graft to kink or deform, resulting in reduction of blood flow from the HeartMate II LVAS pump, pump/graft thrombosis, or perforation of the outflow graft.

Altuzan (bevacizumab): Counterfeit Product - Contains no Active Ingredient (Apr 3)
FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg/16ml (bevacizumab),an injectable cancer medication, found in the U.S. contains no active ingredient.

American Regent Initiates Nationwide Voluntary Recall of Cyanocobalamin Injection, USP, 100 mcg/mL, 1ml Vial Lot #s 1662, 1679, 1683 Due to Cracks in the Vials (Apr 2) 
American Regent is undertaking this voluntary recall of Cyanocobalamin Injection, USP, lots: 1662, 1679, and 1683 because cracks can form in the heel (bottom) and sides of some vials of these lots. These cracks may lead to a lack of assurance of sterility and the potential for development of glass particulates.

For more product safety information, please visit our MedWatch website at http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

PRODUCT APPROVALS: 

FDA approves imaging drug Amyvid (Apr 10) 
FDA approved Amyvid (Florbetapir F 18 Injection) a drug for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.

FDA approves first Avapro/Avalide generics to treat high blood pressure, kidney disease (Apr 2) 
The FDA approved the first generic versions of Avapro (irbesartan) and Avalide (irbesartan and hydrochlorothiazide) tablets for the treatment of high blood pressure.

OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:  

Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
This notice solicits comments on information collection on financial disclosure by clinical investigators. Submit either electronic or written comments on the collection of information by May 29, 2012.

Comment Request; Experimental Study of Graphic Cigarette Warning Labels 
This notice solicits comments on the Experimental Study of Graphic Cigarette Warning Labels that is being conducted in support of the graphic label provision of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).  Submit either electronic or written comments on the collection of information by May 29, 2012.

Comment Request; Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act 
This notice solicits comments on the collection of information associated with adverse event reporting and recordkeeping for dietary supplements as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (the DSNDCPA).  Submit either electronic or written comments on the collection of information by May 22, 2012.

Draft Guidance for Industry: Direct-to-Consumer Television Advertisements -- FDAAA DTC Television Ad Pre-Dissemination Review Program  This draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements provision of the FD&C Act. Submit either electronic or written comments on the draft guidance by May 14, 2012.

Draft Guidance: Classifying Significant Postmarketing Drug Safety Issues This draft guidance describes FDA's current approach to classifying a significant postmarket drug safety issue as a “priority” tracked safety issue (TSI) or a “standard” TSI, with the capability of elevating some priority TSIs to an “emergency” status. Submit either electronic or written comments on the draft guidance by May 8, 2012.

Draft Guidance: Drug Safety Information -- FDA's Communication to the Public  
This draft guidance describes FDA's current approach to communicating important drug safety information, including emerging drug safety information, to the public and the factors that influence when the information is communicated. Submit either electronic or written comments on the draft guidance by May 8, 2012.

Draft Guidance for Industry on Limiting the Use of Certain Phthalates as Excipients in Center for Drug Evaluation and Research-Regulated ProductsThis draft guidance provides the pharmaceutical industry with CDER's current thinking on the potential human health risks associated with exposure to DBP and DEHP. Submit either electronic or written comments on the draft guidance by May 31, 2012.

Utilizing Innovative Technologies and Other Conditions of Safe Use To Expand Access to Nonprescription Drugs
Submit either electronic or written requests for oral presentations and comments by March 9, 2012.  Either electronic or written comments will be accepted after the hearing until May 7, 2012.

Guidance for Industry: Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage: Draft Guidance 
Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: Draft Guidance  
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance 

Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Draft Guidance: Draft Guidance  
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register

ANNOUNCEMENTS:  

FDA takes steps to protect public health - Agency working with animal, drug and medical communities to promote judicious antimicrobial use (Apr 11)
The FDA announced that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals. 

FDA announces plans to pilot end-stage kidney disease technology in new program (Apr 9)
Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.  

Innovation Pathway  (Apr 9) 
FDA's Center for Devices and Radiological Health (CDRH) launched its second version of the Innovation Pathway, called "Innovation Pathway 2.0."  Innovation Pathway 2.0 offers new and modified tools and methods to deepen collaboration between the FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory process more efficient and timely.

FDA's China Offices Focus on Product Safety (Apr 4)
More than three years after a series of safety scares involving Chinese exports, officials in the Food and Drug Administration’s China office say the Chinese are on their way to developing an infrastructure that better ensures product safety.

Medical Device Epidemiology Network Initiative (MDEpiNet) (Apr 3)
The Medical Device Epidemiology Network Initiative (MDEpiNet)is a collaborative program through which CDRH and external partners share information and resources to enhance our understanding of the safety and effectiveness of medical devices after they are marketed.

Obama administration takes action to address tobacco epidemic: FDA takes two significant actions (Mar 30)
FDA released two separate draft guidance documents to help fight the tobacco epidemic and stop children from using tobacco. The draft guidance documents implement provisions of the Family Smoking Prevention and Tobacco Control Act that will ultimately provide the public with previously unknown information about the chemicals in tobacco products and help prevent misleading marketing about the risks associated with tobacco products.

FDA to discuss risks and benefits of metal-on-metal hip replacements:Expert, patient recommendations being sought (Mar 29)
FDA announced that it is seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems as well as potential patient and practitioner recommendations on the use of MoM hip systems and the management of patients implanted with such devices. FDA will discuss these issues at a two-day expert advisory panel meeting on June 27-28, 2012.

Recent Spanish versions of Drug Safety Communications: (Given various time and review constraints, availability of Spanish language versions of Drug Safety Communications will generally follow the English version by about 1-2 weeks.)

Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para Celexa (citalopram bromhidrato) relacionadas con el riesgo potencial de ritmo cardiaco anormal con dosis altas
Comunicado de la FDA sobre la seguridad de los medicamentos: Cambios importantes en la etiqueta de seguridad de los medicamentos para reducir el colesterol conocidos como estatinas 
Comunicado de la FDA sobre la seguridad de los medicamentos: La interacción entre ciertos medicamentos para el VIH o hepatitis C y los medicamentos con estatinas para reducir el colesterol, puede aumentar el riesgo de lesiones musculares

UPCOMING MEETINGS:

Public Workshop on the Role of Naloxone in Opioid Overdose Fatality Prevention (Apr 12)

FDA/Drug Information Association (DIA) Cardiovascular Safety and State-of-the-art Development Issues (Apr 17 – 18)

FDA/ASCO Public Workshop on Minimal Residual Disease (Apr 18) 

Public Hearing on Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice (Apr 23-24)

The Food and Drug Law Institute's (FDLI) 55th Annual Conference (Apr 24-25)

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (Apr 25-26)

FDA/Xavier University Medical Device Conference (May 1-4)  

Pediatric Advisory Committee Meeting (May 7-8) 

Arthritis Advisory Committee Meeting (May 8)


Arthritis Advisory Committee Meeting (May 9)


Endocrinologic and Metabolic Drugs Advisory Committee Meeting (May 10)


Antiviral Drugs Advisory Committee Meeting (May 10)


Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (May 10-11)


Antiviral Drugs Advisory Committee Meeting (May 11) 


Public Hearing on Draft Guidances Relating to the Development of Biosimilar Products (May 11)

Workshop on Natural History Studies of Rare Diseases (May 16-17)

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (May 24)


Peripheral and Central Nervous System Drugs Advisory Committee Meeting (May 24)

Scientific Workshop on the Assessment of Analgesic Treatment of Chronic Pain (May 30-31)

Gastrointestinal Drugs Advisory Committee Meeting (May 31)

Regulation of Pharmaceuticals: A Global Perspective (Jun 6-8)

General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 21)

Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (Jun 27-28)

RESOURCES:

Continuing Education

The Clinical Investigator's CME Program: Transforming a Clinician Into an Investigator: What Does It Take?
Panel discussion moderated by Dr. Leonard Sacks, Acting Director, Office of Critical Path Programs at FDA. This CME/CE activity will help clarify the responsibilities of clinical investigators and address some of the challenges that investigators face today.

Articles

Statins: The Story Behind the Label Changes

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.

Please visit Articles of Interest (http://www.fda.gov/ForHealthProfessionals/ArticlesofInterest/default.htm) to access articles produced by FDA and written for a health professional audience. These articles include FDA News for Health Professionals articles, as well as articles that were published in health professional journals.

Videos

What To Do About Misleading Drug Ads
A video discussing FDA's Bad Ad Program Featuring Michael Sauers, Team Leader for FDAs Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research.

FDA Drug Safety Podcasts Podcasts
FDA Drug Safety Podcast for Healthcare Professionals: Revised recommendations for Celexa (citalopram hydrobromide) related to a potential risk of abnormal heart rhythms with high doses (Mar 30)

Other Resources

For Health Professionals
Additional information for Health Professionals may be found on FDA’s Health Professional website.
  
MedWatch Safety Alerts for Human Medical Products
Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products. Follow us onTwitter to receive the MedWatch Safety Alerts:  

New and Generic Drug Approvals

Medication Guides

2011 Novel New Drugs

Consumer Updates
Timely and easy-to-read articles covering all FDA activities and regulated products 

FDA's MedWatch Safety Alerts: February 2012
FDA's China Offices Focus on Product Safety
FDA and ISMP Work to Prevent Medication Errors 
Less Risky Tobacco Product? Only if the Science Says So 
What Are You Smoking (or Chewing or Inhaling)? 
FDA Continues to Study BPA 

FDA Voice
FDA Voice is the official blog from FDA's senior leadership and staff. FDA Voice is a new forum and through upcoming blog posts you will find news, background, announcements and other information about the work done at the FDA on behalf of the American public. 
Making a Difference: Innovation Pathway and Entrepreneurs in Residence (Apr 10)
-? Improving the Integrity of the Drug Supply in a Global Marketplace (Apr 10) 
Balancing Innovation and Safety: FDA's Innovation Pathway (Apr 9)  
Getting More Accurate Tobacco Information to Consumers (Mar 30)

Best regards, 
Office of Special Health Issues
Food and Drug Administration

(Send your news to foodconsumer.org@gmail.com, Foodconsumer.org is part of the Infoplus.com ™ news and information network)

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