The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [ drotrecogin alfa (activated)].

The U.S. Food and Drug Administration (FDA) is alerting health care professionals that repackaged intravitreal injections of Avastin ( bevacizumab ) have caused a cluster of serious eye infections in the Miami, Florida area.

On August 22, 2011, the FDA approved the combination of Pegasys and Copegus for the treatment of chronic hepatitis C virus ( HCV ) infection in pediatric patients 5 through 17 years of age.

Tri State Beef, a Cincinnati, Ohio, establishment, is recalling approximately 228,596 pounds of beef products that may be contaminated with E. coli O157 : H7 , the U.S. Department of Agriculture’s Food Safety and Inspection Service ( FSIS ) announced today. The following product is subject to recall: Combo bins of "TRI-STATE BEEF CO., INC BONELESS BEEF." Each bin bears the establishment number "EST. 1750" inside the USDA mark of inspection. The products subject to recall were produced between July 19, 2011 and July 22, 2011, and sold to federally-inspected establishments for ...

The FDA has received reports of serious central nervous system (CNS) reactions when the antibacterial drug linezolid (Zyvox) is given to patients taking psychiatric medications that work through the serotonin system of the brain (serotonergic psychiatric medications).

The FDA is warning consumers not to eat papayas from Agromod Produce, Inc., a distributor in McAllen,Texas.

The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy ( PML ), a rare but serious brain infection, associated with use of Tysabri ( natalizumab ) for the treatment of multiple sclerosis (MS) and Crohn's disease.

In January 2008, manufacturers voluntarily removed over-the-counter (OTC) infant (less than 2 years of age) cough and cold products from the market due to safety concerns. Later in fall of 2008, manufacturers also voluntarily relabeled these cough and cold products to state: “do not use in children under 4 years of age.” However, there are concerns that many parents may be giving cough and cold products that remain on the market - those designed for older children - to their infants. FDA reminds all caregivers never to give a child under two years of age any kind of cough and cold p...

The U.S. Food and Drug Administration announced today that it has approved the influenza vaccine formulation for the 2011-2012 vaccine that will be used by the six manufacturers licensed to produce and distribute influenza vaccine for the United States.

The U.S. Food and Drug Administration (FDA) is informing the public of important product safety changes to the influenza drug Tamiflu ( oseltamivir phosphate) for oral suspension.