Pharma Blog Watch

Ketek Recommendations (Drug Injury Watch)
In his blog, Tom Lamb writes about the FDA advisory committee meeting last week to discuss sanofi-aventis' antibiotic Ketek. The committee recommended that the FDA: "(a) withdraw approval of Ketek for bronchitis and sinusitis, (b) mandate a 'black box' warning for Ketek regarding serious side effects such as liver damage and liver failure and (c) require distribution of a patient medication guide with future Ketek prescriptions." If the FDA adopts these changes, "one must wonder whether sanofi-aventis will continue to market Ketek in the U.S."

"To be clear, the FDA advisory panel did not recommend a Ketek recall for safety reasons. But if the FDA fully adopts their recommendations, Ketek sales may be greatly diminished going forward," he writes. "In turn, sanofi-aventis could follow the lead of another drug company when it experienced increasing scrutiny about the safety of its antibiotic. Earlier in 2006, Bristol-Myers Squibb (BMS) announced that it would stop marketing Tequin in the U.S. for 'business' reasons — a move which was very similar to the method that was used by BMS during its withdrawal of their antidepressant drug Serzone in 2004."