FDA Releases First Set Of Drug, Biologic Safety Reviews

15th Jun 2010 20:33

By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON (Dow Jones)--The Food and Drug Administration Tuesday released safety summaries of 26 recently approved products as part of a new initiative to formally track the safety of drugs and biologics after they are approved. Agency officials said they would release such summaries on a quarterly basis. However, they said unexpected or new safety issues found during the reviews or other FDA drug-safety efforts, would continue to be released on the agency's Web site as soon as the agency becomes aware of a possible problem. Indeed, one of the products on the list, GlaxoSmithKline PLC's (GSK) Rotarix vaccine, was vetted last month by an agency advisory committee after fragments of a pig virus were found in the vaccine. The FDA then determined that the vaccine was safe to use. A 2007 law requires FDA to prepare the safety summaries within 18 months after a product's approval or after it has been used by 10,000 patients, whichever comes later. The safety summaries are based on comprehensive look at safety data early in a product's post-approval life cycle and are based on reports by manufacturers, health care providers, consumers to the FDA's adverse event reporting system and periodic safety information submitted to the agency from manufacturers. The safety reviews also include information from medical literature and any information from clinical trials that involve the product under review. Information from the vaccine adverse event reporting system, a database run by FDA and the Centers for Disease Control and Prevention will also be used to track new vaccines. For most of the 26 products reviewed, the agency said it didn't find any unexpected serious adverse events that weren't already described in the drug's label. All of the products were approved in 2008. However, the agency said it was reviewing reports of drug administration errors associated with the migraine medicine Treximet, marketed by GlaxoSmithKline, and was seeking additional information from Sepracor Inc. (SEPR) about its asthma medicine Alvesco after receiving reports discussing a possible malfunction of the device used to deliver the medication. -By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; [email protected] (END) Dow Jones Newswires June 15, 2010 15:33 ET (19:33 GMT)