After months of controversy over the disclosure of side-effect data concerning Sanofi-Aventis’ Ketek antibiotic, the FDA this morning decided to issue a Black Box warning and require a Patient Guide to be distributed with the medicine.

Moreover, two of three previously approved indications — acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis — are being removed from the label. In a statement, the agency said it “determined that the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity (acquired outside of hospitals or long-term care facilities.”

This move isn’t surprising. Remember that a former FDA drug reviewer, David Ross, publicly accused the agency of covering up allegations of fraud in a Ketek clinial trial and pressuring him to make Sanofi interests a higher priority than other concerns. Then he claim the new FDA commish, Andrew von Eschenbach, intimidated agency employees in a meeting last June.

The episode, which made front-page headlines and drew the ire of Sen. Chuck Grassley, is far from over. The Ketek saga, unfortunately, serves as a painful reminder that drug safety is an important issue that requires more diligence than the FDA has been able or willing to provide.

The timing is certainly curious, though. Why? Tomorrow, the House Energy and Commerce Committee’s oversight committee is holding a hearing on - guess what? - drug safety. Do you think the Ketek change allows the FDA to say it takes safety seriously?

Would anyone believe FDA officials if they were to do so?

[tags]Antiobiotics, Black Box, Drug Safety, FDA, Ketek[/tags]