In a move sure to cause controversy, the FDA will let some sunshine in on its investigations of adverse event reports. Every quarter, the agency will release a list of drugs under investigation because of complaints about side effects. The nature of the complaints will be included in the report, but the number of complaints--or their seriousness--won't be. So is this too much information? Or not enough context?
Though this disclosure is required by the new FDA law enacted last year, the reports are already being greeted with concern by drugmakers--and even agency officials. Both worry that patients might stop taking their meds because of the disclosed investigations, even though many of them may turn out to be false alarms.
The FDA has already warned patients and docs about some of the drugs on the first list of 20 under scrutiny, such as TNF blockers, in the news last week. But some of the listed meds are new. For instance, Biogen Idec and Elan's Tysabri is listed because of reported cases of melanoma in patients taking the drug. Others named in the report include Eli Lilly's antidepressant Cymbalta and Purdue Pharma's Oxycontin. (See the entire list via the FDA link below.)
- check out the FDA's release
- read the Washington Post story
- see the article in the Wall Street Journal