FDA NEWS

Combating Antibiotic Resistance
Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics.

Recalls and Safety Alerts: Updated Labeling Changes for Tamiflu and Relenza
Roche Laboratories has updated information on neuropsychiatric events for Tamiflu (oseltamivir phosphate), a drug that's used to treat or prevent influenza in patients 1 year and older. The revised labeling reminds practitioners that some patients...

FDA Embarks on Major Hiring Initiative for its Public Health Mission
The FDA is hiring hundreds of individuals with science and medical backgrounds to help meet the agency's responsibilities to assure the safety and/or efficacy of human and veterinary drugs, biological products, medical devices, food, cosmetics and products that emit radiation.

Sentinel System to Monitor Medical Product Safety
FDA's new Sentinel Initiative aims to establish a national electronic system for tracking medical product performance.

FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now
CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.

FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled
The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.

Recalls and Safety Alerts: Liver Injury with Tysabri
Biogen Idec and Elan Pharmaceuticals are warning healthcare professionals about reports of clinically significant liver injury in patients taking Tysabri (natalizumab). Tysabri is a monoclonal antibody used to treat certain patients with relapsing f...

Pregnant Women to Benefit from Better Information
A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding.