The U.S. Food and Drug Administration today approved Fycompa (perampanel) tablets to treat partial onset seizures in patients with epilepsy ages 12 years and older.
Category Archives: Drug Safety Information Podcasts
FDA expands approved use of Sapien artificial heart valve
The U.S. Food and Drug Administration today expanded the approved indication for the Sapien Transcatheter Heart Valve (THV) to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes
On Oct. 17, the U.S. Food and Drug Administration approved Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).
FDA takes action against thousands of illegal Internet pharmacies
The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 4,100 Internet pharmacies that illegally sell potentially dangerous, unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products, and removal of offending websites.
FDA campaign aims to protect consumers from the risks of fake online pharmacies
The U.S. Food and Drug Administration today launched a national campaign to raise public awareness about the prevalence of fraudulent Internet pharmacies, which can be dangerous to patient health, and to help consumers make safe purchases.
FDA approves Humira to treat ulcerative colitis
The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults.
FDA approves first subcutaneous heart defibrillator
The U.S. Food and Drug Administration today approved a heart defibrillator that helps to restore regular heart rhythms with leads that can be implanted just under the skin (subcutaneously) instead of connected directly into the heart.
FDA approves new treatment for advanced colorectal cancer
The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).
New FDA task force will support innovation in antibacterial drug development
The U.S. Food and Drug Administration today announced the formation of an internal task force that will support the development of new antibacterial drugs, a critical public health care goal and a priority for the agency.
FDA advises consumers not to eat Trader Joe’s Valencia Creamy Salted Peanut Butter
The FDA’s top priority is ensuring the safety of our food supply. The FDA, the Centers for Disease Control and Prevention (CDC) and state and local public health officials are investigating a multi-state outbreak of Salmonella Bredeney infections possibly linked to Trader Joe’s Valencia Creamy Salted Peanut Butter, with a Stock Keeping Unit (SKU) identifier of 97111.
The CDC recommends that consumers do not eat Trader Joe’s Valencia Creamy Salted Peanut Butter made with sea salt. This is especially important for children under the age of 5 years, elderly adults, and people with weak immune systems.
Dispose of any remaining jars of peanut butter in the home or return the product to any Trader Joe’s grocery store. Trader Joe’s has encouraged consumers to return the product to any Trader Joe’s store for a full refund.
The CDC reports a total of 29 people infected with the outbreak strain of Salmonella Bredeney from 18 states