![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Pharma Blog Watch
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."
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct