The Letter Concerns Black-Box Warning, Prescribing Changes, And Patient Medication Guide Announced Back In Mid-February 2007

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 26, 2007 the FDA announced that a so-called "Dear Doctor" letter regarding the antibiotic Ketek (telithromycin) has been sent by Sanofi-Aventis to healthcare professionals alerting them to new safety information for Ketek.

As one may recall, in mid-February 2007 the FDA and Sanofi-Aventis announced some important new prescribing and safety information for Ketek.  This important information was to be disseminated by several means, including a new package insert, or label, for Ketek that would have a black-box warning and label changes regarding the new prescribing guidelines as well as some associated side effects; in addition, there was a detailed medication guide for patients.  A summary of those items follow:

• The black-box warning states that Ketek is contraindicated in patients with pre-existing myasthenia gravis, a disease that causes muscle weakness;
• The antibiotic Ketek should be prescribed for community-acquired pneumonia, only, and should no longer be used as treatment for acute bacterial exacerbation of chronic bronchitis nor acute bacterial sinusitis.
• As for the other label changes, warnings were strengthened for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances associated with Ketek; and,
• The new Patient Medication Guide is intended to let patients know about the risks of Ketek and how to use this antibiotic safely.

To our knowledge, no explanation was issued by the FDA nor Sanofi-Aventis about why there was an apparent six-week delay in sending out this March 2007 Dear Doctor letter regarding the important Ketek safety information that was first raised by them back in February 2007.