Sunday, May 11

UPDATE: FDA Unveils Report On Drugs Under Investigation

WASHINGTON -(Dow Jones)- The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.
The list includes a wide array of drugs, from Eli Lilly & Co.'s (LLY) anti- depressant Cymbalta to Purdue Pharma LP's powerful painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated.
The FDA has already sent out warnings on a handful of the drugs on the list. For instance, the report lists TNF blockers - such as Johnson & Johnson's (JNJ) Remicade - as being potentially associated with cancer in children. The FDA said in June it was investigating the possible link.
But there appear to be new ones, too. The report lists Biogen Idec Inc. (BIIB) and Elan Corp. PLC's (ELN) multiple sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking the drug, but the FDA hasn't previously said it was investigating the drug for this side effect.
The intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems with the drugs to the FDA. The list doesn't represent a comprehensive list of drugs the FDA is investigating, Seligman said.
The report is generated from the agency's adverse-event-reporting database. That compilation consists of voluntary reports from patients and health-care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.
Seligman said the FDA is hopeful the quarterly reports will encourage people to report adverse events.
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