FDA NEWS

U.S. Grown Jalape�o and Serrano Peppers Not Connected to Salmonella Saintpaul Outbreak
The U.S. Food and Drug Administration is advising consumers that jalape�o and serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. However, the FDA continues to advise consumers to avoid raw jalape�o peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico.

Avastin (bevacizumab)
Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination.

Abacavir (marketed as Ziagen) and Abacavir-containing Medications
Association between HLA-B*5701 allele and hypersensitivity reactions identified and patient screening for the allele recommended before starting or restarting treatment.

Federal Agents Seize more than $24 Million in Unapproved New Drugs
Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

Recalls and Safety Alerts: FDA Takes Action on Injectable Colchicine
FDA is taking action against companies marketing injectable colchicine, which is an unapproved form of the drug. Colchicine is an anti-inflammatory used in the treatment of gout. Colchicine tablets, which are less hazardous, are not affected by FDA...

Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product
At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.

New Medical Products: New Non-Refrigerated Coagulation Product
FDA has approved a new formulation of the genetically engineered version of Factor VIIa that does not need to be refrigerated. Factor VIIa is a plasma protein essential for blood clotting that can be used to treat and prevent bleeding in people with...