Healthy Skepticism Library item: 7105
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
US FDA undecided whether to withdraw Sanofi-Aventis' Ketek from sale
Forbes 2006 Dec 18
Abstract:
PARIS (AFX) – The US Food and Drug Administration said Friday it has not yet made a decision on whether to withdraw the Sanofi-Aventis antibiotic Ketek from sale, but expressed concern about its use for treating minor infections.
An FDA panel found Ketek’s benefits outweighed its risks for treating pneumonia, but didn’t outweigh the risks when used in treating bronchitis and sinusitis.
Sanofi-Aventis (nyse: SNY – news – people ) said it will hold talks with the FDA about recommendations the regulatory agency could make for the drug’s use.
In June, Sanofi-Aventis said it revised the prescribing information for Ketek following talks with the FDA, adding a bold-type warning and updated information about possible adverse effects.
