Ketek

telithromycin

Ketek was approved by the FDA in 2004 to treat respiratory illnesses such as acute sinusitis, pneumonia and bronchitis. Sanofi-Aventis revised the drug’s warning label after an FDA advisory was issued on June 29, 2006 warning of 4 fatalities from acute liver failure in patients who took Ketek. Ketek’s label had contained a precaution about watching for signs of liver disease. The new label has been upgraded to a warning of possible liver injury while taking Ketek and advises physicians to discontinue the drug promptly if any signs or symptoms of liver injury develop.

The FDA reviewed Sanofi-Aventis’ post-marketing adverse event reports and found 12 cases of acute liver failure in patients on Ketek. Four of these cases were fatal. Another case required a liver transplant. An additional 23 patients suffered acute liver injury from taking Ketek. Ketek’s new label will also note reports of fatal worsening of a neuromuscular condition known as myasthenia gravis. Three deaths from myasthenia gravis in patients on Ketek have been reported.

Myasthenia gravis is an autoimmune disorder that attacks voluntary muscles such as those that control swallowing, speech, neck and limb movements. Symptoms include muscle weakness, impaired speech, drooping eyelids, and difficulty in speech, but can worsen to include generalized paralysis and eventual death from impaired breathing. The patients who died from myasthenia gravis were in their 70s and 80s and taking Ketek for respiratory infections.