The FDA announced labeling changes to Ketek. Sanofi-Aventis’s antibiotic has long been a controversial drug inside the agency and in the community of activists fighting the industry. Sidney Wolfe’s website had flatly urged consumers not to take the drug. Ketek (telithromycin) was approved in the U.S. in 2004, three years after being blessed by the EMEA.

The safety issue is liver toxicity. Last month, the Annals of Internal Medicine published an article documenting a single physician who saw three Ketek patients. One enjoyed a recovery. One died. The third had a liver transplant.

In addition to a “black box” warning, the FDA and Sanofi-Aventis have jointly created a “Patient Medication Guide,” an FDA-approved information sheet that will be provided to patients with each prescription.

The agency’s statement suggests it slowly came to agree with critics of the drug: “The changes include the removal of two of the three previously approved indications—acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis—from the drug’s label. The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications.”

Steven Galson, director of the Center for Drug Evaluation and Research (CDER), is quoted in the FDA announcement: “Today’s action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give healthcare providers the most up-to-date prescribing information.”

In the summer of 2006, Ketek was identified by another FDA staffer, whistleblower David Graham, as an instance of poor agency decisionmaking. “It’s as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned,” Dr. Graham wrote in an internal FDA memo published by the New York Times.

Bloomberg has a related story about Congress attracting current or former FDA staffers. The news service notes that the FDA’s David Ross has been recruited to help write legislation to fix the agency. In that story, Ross alleges that unnamed FDA managers approved Ketek after forcing him to withdraw his objection to the drug.