FDA to rewarn docs on Plavix, Prilosec combo

If you were doubting its word on the dangers of combining Plavix with Prilosec, the FDA plans to send out a reminder. As the Wall Street Journal reports, agency officials worry that a recently released study will persuade clinicians that the combo isn't as risky as FDA has warned.

In March the FDA added a "black box" warning to Plavix, saying that it was not as effective at preventing blood clots in people who metabolize it poorly. Among the poor metabolizers? According to the label, patients who also take Prilosec. The new warning was based on research conducted by Plavix's co-marketers Sanofi-Aventis and Bristol-Myers Squibb.

But a recent New England Journal of Medicine study, known as Cogent, found that patients using both drugs didn't have a higher risk of heart problems. The research generated lots of buzz, with some experts saying that FDA jumped the gun when it warned against combining Plavix with heartburn meds.

The agency says it's not so. FDA officials told the Journal that the Cogent study was too small to be significant and that it used a delayed-release form of Prilosec that's not actually on the market. FDA is "absolutely not" going to change the drug-combo warning, the FDA's Mary Ross Southworth told the newspaper, but will issue a reminder notice instead.

- see the WSJ piece

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