FDA Alerts

Florida Firm Recalls Imported Beef Products Due To Potential Animal Drug Contaminant
Northwestern Meat, Inc., a Miami, Fla. firm, is recalling approximately 6,240 pounds of frozen boneless beef products imported from Honduras that may contain the animal drug Ivermectin , the U.S. Department of Agriculture’s Food Safety and Inspection Service ( FSIS ) announced today.
Tri State Beef Recall Due To E. Coli Risk
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 ...
FDA Drug Safety Communication: Methylene blue (UPDATE)
The U.S. Food and Drug Administration (FDA) has received reports of serious central nervous system (CNS) reactions when the drug methylene blue is given to patients taking psychiatric medications that work through the serotonin system of the brain ( serotonergic psychiatric medications).
Drug Safety Communication: Zyvox (UPDATE)
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).
Foodborne Outbreak Potentially Associated With Papaya
The FDA is warning consumers not to eat papayas from Agromod Produce, Inc., a distributor in McAllen,Texas.
FDA Drug Safety Communication: Letairis
The U.S. Food and Drug Administration (FDA) is removing the warning related to liver injury from the boxed warning of the Letairis ( ambrisentan ) tablet label.
FDA Drug Safety Communication: Pradaxa
The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa ( dabigatran etexilate mesylate ) capsules.
FDA Drug Safety Communication: Benicar
After reviewing the results of the ROADMAP and ORIENT trials, the FDA has determined that the benefits of Benicar continue to outweigh its potential risks when used for the treatment of patients with high blood pressure according to the drug label. Benicar is not recommended as a treatment to delay or prevent protein in the urine ( microalbuminuria ) in diabetic patients. Patients should consult their healthcare professional if they have any questions or concerns about taking Benicar . Daiichi Sankyo , the makers of Benicar , have agreed to work with the FDA to perform additional ...
FDA Drug Safety Communication: Revlimid
The U.S. Food and Drug Administration (FDA) is informing the public that we are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with Revlimid ( lenalidomide ) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. FDA is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review. At this time, FDA recommends that patients continue their Revlimid treatment as prescribed by their...
FDA Drug Safety Communication: TNF blockers
The U.S. Food and Drug Administration (FDA) is informing the public that it continues to receive reports of a rare cancer of white blood cells (known as h epatosplenic T-Cell lymphoma or HSTCL ), primarily in adolescents and young adults being treated for Crohn’s disease and ulcerative colitis with medicines known as tumor necrosis factor ( TNF ) blockers, as well as with azathioprine , and/or mercaptopurine . Crohn's disease and ulcerative colitis cause inflammation of the digestive system. Common symptoms are pain in the abdomen, cramps, and diarrhea. Bleeding from the rectum, wei...