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:
CareFusion Alaris Pump Module Model 8100: Class I Recall - Motor Stalls During Infusion (Aug 24)
Motor stalls could result in a termination of infusion.
Reumofan Plus: Recall - Undeclared Drug Ingredient (Aug 21)
FDA has received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus since the agency issued its first warning about the product.
Hospira Propofol Injectable Emulsion: Recall - Glass Vial Defect (Aug 16)
Risks associated with this defect could include tissue necrosis in one or more organs that could result in stroke, myocardial infarction, respiratory failure, and loss of renal and hepatic function.
St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety Communication - Premature Insulation Failure (Aug 16)
ICD lead malfunction may cause abnormal sensing or pacing, or delivery of inappropriate or no shock therapy, which could result in serious adverse events, including death.
Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume (Aug 16)
Opioid pain medications such as hydromorphone have life-threatening consequences if overdosed.
For more product safety information, please visit our MedWatch website at http://www.fda.gov/medwatch
PRODUCT APPROVALS:
FDA approves new combination pill for HIV treatment for some patients (Aug 27)
FDA approved Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate), a new once-a-day combination pill to treat HIV-1 infection in adults who have never been treated for HIV infection.
FDA approves first generic Actos to treat type 2 diabetes (Aug 17)
FDA approved the first generic version of Actos (pioglitazone hydrochloride) tablets.
For information on drug approvals, please visit Drugs@FDA
OPPORTUNITIES FOR COMMENT AND/OR RECENTLY PUBLISHED GUIDANCES:
Proposed Rule: Unique Device Identification System (UDI) FDA is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act by section 226 of the Food and Drug Administration Amendments Act of 2007.
Reclassification from schedule 3 to 2, of combination hydrocodone productsOctober 29-30, 2012 Drug Safety and Risk Management (DsaRM) Advisory Committee Meeting will discuss the reclassification from schedule 3 to 2, of combination hydrocodone products. The Committee will discuss the potential for abuse of drugs containing hydrocodone either combined with other analgesics or as an antitussive. FDA opened docket number FDA-2012-N-0548. Submit comments by November 6, 2012.
ANNOUNCEMENTS:
Request for (Grant) Applications (RFA): Extended-Release and Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS)The REMS Program Companies would like to make your organization aware of grant funds available to support accredited independent continuing education for the ER / LA class-wide opioid analgesics REMS.
UPCOMING MEETINGS:
Anti-Infective Drugs Advisory Committee Meeting (Sept 5)
Novartis Pharmaceuticals' tobramycin inhalation powder for the management of cystic fibrosis patients infected with the bacterium Pseudomonas aeruginosa.
Public Meeting--Strengthening the National Medical Device Postmarket Surveillance System (Sept 10)
The purpose of the meeting is to solicit public feedback regarding the medical device postmarket surveillance system in the United States.
Pediatric Advisory Committee Meeting (Sept 11)
Discuss pediatric-focused safety reviews for Kapvay, Vyvanse, Ofirmev, ella, Beyaz, LoLoestrin Fe, Aridol, Augmentin XR, Afinitor, Moxeza, and Lastacaft. Discuss the safety of and the ongoing propriety of the humanitarian device exemption for the Melody Transcatheter Pulmonary Valve and Ensemble Delivery System and the Elana Surgical Kit.
MDEpiNet 2012 Annual Meeting: The Medical Device Epidemiology Network as a Partnership for Building Global Medical Device Epidemiology and Surveillance Capabilities (Sept 11)
The topic to be discussed is setting strategic priorities and implementing an action plan for sustainable partnership toward improving regulatory science and the public health.
Public Workshop: Leveraging Registries With Medical Device Data for Postmarket Surveillance and Evidence Appraisal Throughout the Total Product Life Cycle (Sept 12-13)
The topic to be discussed is best practices for use of registries with medical device data for postmarket surveillance, clinical studies, and evidence appraisal.
Cardiovascular and Renal Drugs Advisory Committee Meeting (Sept 13)
Cardiokine Biopharma's lixivaptan for the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone; West-Ward Pharmaceutical's phenylephrine hydrochloride injection to increase blood pressure in acute hypotensive states.
Blood Products Advisory Committee (Sept 20-21)
Discuss hepatitis E virus and blood transfusion safety; Octapharma’s biologics license application for Pooled Plasma (Human, Solvent/Detergent Treated); considerations for strategies to further reduce the risk of bacterial contamination in Platelets; summary of September 6-7, 2012 public workshop on the risks and benefits of hydroxyethyl starch solutions.
FDA 2nd Annual Health Professional Organizations Conference (Oct 4)
The aim of the conference is to further the public health mission of the FDA through training, collaboration, and structured discussion between health professional organizations and FDA staff.
Drug Safety and Risk Management Advisory Committee Meeting (Oct 29-30)
Discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive.
FDA's Clinical Investigator Training Course (Nov 13-15)
This course is designed for physicians, nurses, pharmacists and other health care professionals involved in clinical trials.
RESOURCES:
Continuing Education
-Medscape CME/CE: Your Patient Has an Adverse Reaction to a Drug: How to Report to FDA's MedWatch (Released Jul 9)
This article is the first in a series of activities in collaboration with FDA and Medscape Education on how to report safety issues to the FDA and how these reports are used to ensure safe use of drugs and medical products
-Medscape CME/CE: Introducing the REMS Program for the Transmucosal Immediate-Release Fentanyl Products (Released Jun 29)
The goal of this activity is to provide education about the risk evaluation and mitigation strategy for the transmucosal immediate-release fentanyl products.
-Medscape CME/CE: Risk Evaluation and Mitigation Strategies: An Introduction for Physicians, Nurses, and Pharmacists (Released May 15)
The goal of this activity is to provide education to clinicians and pharmacists about risk evaluation and mitigation strategies.
Videos
-A Short Tutorial on REMS: The FDA Perspective
Featuring Dr. Gerald Dal Pan, Acting Director, FDA Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research
Interviews
-At-Home Rapid HIV Testing: An Interview With FDA
Featuring Elliot Cowan, PhD, Chief, Product Review Branch, Division of Emerging and Transfusion Transmitted Diseases, Center for Biologics Evaluation and Research
Other Resources
Consumer UpdatesTimely and easy-to-read articles covering all FDA activities and regulated products
-Reumofan Products Pose Risk to Consumers
-Is Post-Surgery Codeine a Risk for Kids?
-Is Rinsing Your Sinuses Safe?
-Tattoo Inks Pose Health Risks
MedSun Medical Product Safety NetworkThe Medical Product Safety Network (MedSun) improves FDA’s understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns. The MedSun Web page is a newsletter-based website which provides monthly updates about timely medical device issues that may impact patient safety.
FDA Voice: the official blog from FDA's senior leadership and staff.
- Additional Protections for Children Who Participate in Clinical Research
Best regards,
Office of Special Health Issues
Food and Drug Administration
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