Healthy Skepticism Library item: 7118

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Publication type: news

Steyer R.
FDA Staff Supports Sanofi Drug
The Street.com 2006 Dec 13
http://www.thestreet.com/_yahoo/newsanalysis/pharmaceuticals/10327685.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

Abstract:

A Food and Drug Administration staff report says the benefits of the Sanofi-Aventis (SNY – commentary – Cramer’s Take – Rating) antibiotic Ketek outweigh the risks.
The staff report, issued Wednesday, comes one day before a pair of FDA advisory committees will hold hearings on the drug that the agency approved in April 2004.

Ketek has become controversial because post-marketing reports show several cases of liver damage and death. The company has toughened warning labels, and a big clinical trial used in support of Ketek’s application was later found to be unreliable.

In addition, the Senate Finance Committee has been investigating the FDA and the Ketek-approval process. The committee’s chairman, Sen. Chuck Grassley, R-Iowa, said that the FDA “intentionally withheld key information” from an advisory committee when that panel reviewed the Ketek application in January 2003.

FDA staff reports are routinely issued before advisory panels meet. Wednesday’s report suggests continued monitoring of Ketek for liver damage, a further strengthening of the label and greater communication to doctors about patients who are most susceptible to side effects.

The regulatory agency has noted that Ketek has been linked to “rare cases of serious liver injury and liver failure with four reported deaths and one liver transplant.” Sanofi-Aventis revised its label to reflect this information.

The advisory panels will assess whether Ketek’s risks outweigh its benefits for each of three indications — community-acquired pneumonia, acute bacterial sinusitis and acute bacterial exacerbation of chronic bronchitis — now approved by the FDA. The drug is given to pneumonia patients who contract the disease outside a hospital or extended-care facility.
The FDA staff report says that side effects identified after Ketek reached the market and questions about clinical trials may have the most impact on assessing the drug’s pros and cons in treating sinusitis and bronchitis, “which are often self-resolving conditions.”

The advisory panels could vote on strengthening the Ketek label, or they could recommend keeping, restricting or withdrawing FDA approval for any of the indications. The FDA isn’t bound by advisory panel recommendations, but it usually follows them.

Although these advisory groups are only supposed to comment on Ketek, sometimes panels make more sweeping recommendations. If they do, their suggestions could affect the development and testing of potential competitors to Ketek and to other types of antibiotics.

Sanofi-Aventis says the drug produced about $50 million in U.S. sales for the first half of 2006.