FDA Unveils List of 20 Drugs
In Side-Effect Probes-
Goal Is to Provide Signs of Possibility Of Adverse Effects
By JARED A. FAVOLE
September 5, 2008
WASHINGTON -- 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 antidepressant Cymbalta to Purdue Pharma LP's 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. (See the FDA's list of drugs that are under investigation.)
The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers -- such as Johnson & Johnson's Remicade -- as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn's.
But there appear to be new ones, too. The report lists Biogen Idec Inc. and Elan Corp.'s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn't previously said it was investigating the drug for this side effect.....read more here.
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