December 2006 FDA Meeting Will Focus On Side Effect Risks, While Fraud Investigation Continues
A November 14, 2006 Associated Press (AP) article was the first to report that in December 2006 the FDA will convene an advisory panel of experts to focus on the reports of adverse drug reactions (ADRs) associated with Ketek and to weigh those ADR reports against the drug's therapeutic benefits. A Reuters article with FDA comments and Ketek sales information provided additional details about the status of Ketek.
Ketek (telithromycin) is generally used as a short-term treatment for respiratory infections, bronchitis, sinusitis, and certain types of pneumonia. Since being approved by the FDA in 2004 there had been enough serious side effect reports made to the FDA that in June 2006 a bolded warning was put on the Ketek label, or package insert, to warn doctors and patients about the possibility of liver failure, drug-induced hepatitis, and other liver damage.
Scheduled for December 14-15, 2006, this FDA meeting of experts is seemingly intended to give guidance to the agency about what to do with Ketek going forward. The advisory panel of experts could suggest that more severe warnings should be put on the Ketek label, e.g., a so-called "black-box warning". Or this advisory panel could go further and recommend that Ketek be withdrawn from the market because of an unfavorable safety profile, i.e., Ketek's benefits are outweighed by its distinct risk of serious side effects.
According to the November 14, 2006 AP article:
Sanofi-Aventis welcomes the opportunity to discuss Ketek, company spokeswoman Lisa Kennedy said. "Based on the data available to us, and in consultation with leading experts, we continue to believe the benefits of Ketek outweigh its risk when the drug is used as directed for its approved indications," Ms. Kennedy said.
In reality, however, the November 2006 announcement that an FDA advisory panel is being convened next month to discuss Ketek seemingly could not come at a worse time for Sanofi-Aventis. The Senate Finance Committee is investigating how Ketek was approved by the FDA in the first place. This Senate investigation is looking into, among other things, allegations that there was extensive misconduct, including fraud, involved with the clinical trials of Ketek prior to it being approved in 2004.
It appears that things may finally be coming altogether unraveled for Ketek, and that the end may be near for Sanofi-Aventis' controversial antibiotic.
(Posted by: Tom Lamb)