FDA issues early-warning trifecta

It was a busy day yesterday for FDA safety reviews, with a trifecta of announcements raising questions about drugs for everything from allergies to HIV. They're all "early communications," which means they're notifications that the FDA spied some troubling research but hasn't yet decided how significant/valid/action-worthy the data is. Here's the Cliff's Notes version:

• Merck's blockbuster allergy-and-asthma med Singulair is under investigation for a possible link to suicide. The FDA is reviewing a handful of reports of mood changes, suicidal behavior and suicide. Just in the past year, Merck has updated the drug's labeling four times to include info on reported side effects, including anxiousness, depression, and suicidal behavior. Now, the agency wants Merck to dig into its Singulair data for evidence of links to suicide. The review could take up to nine months.
• New data on Johnson & Johnson's foot and leg ulcer drug Regranex seems to show that patients have a higher death rate from cancer. The FDA is reviewing the study, conducted between 1998 and 2003. It's a larger study than the 2001 research that showed a higher cancer risk in patients who took Regranex.
• Data pooled from a 33,000-patient study showed that those using GlaxoSmithKline's Ziagen and Bristol-Myers Squibb's Videx had a greater risk of heart attack than patients using other HIV meds. The new study may prompt labeling changes for the drugs, the FDA said, but stressed that it's still looking at incomplete data. GSK and Bristol said their own review of the info showed no increased risk.

Of course all these FDA reviews may end happily, with no new warnings or labeling changes. The "early communication" is part of the FDA's bid to be more transparent and notify the public earlier when concerns about various products arise. We'll keep you posted.

- see Merck's statement on the Singulair review
- read the Singulair story in the New York Times
- check out the J&J article at CNN Money
- check out the WSJ story on the AIDS meds
- get more details from Pharmalot on the HIV drugs

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