FDA Advisory Committee Recommends New Limits and Warnings for Ketek

Two FDA advisory committees agreed on December 15, 2006, that the antibiotic Ketek (telithromycin) should have new black box warnings added to its label about several serious side effects which have been associated with it. “Black box” is the strongest warning the FDA can mandate. Further, the committees recommended that Ketek be limited to second-line therapy for community-acquired pneumonia only, rather than allowing it to be prescribed for acute bacterial bronchitis and acute bacterial sinusitis for which it’s currently approved.

According to a December 16, 2006 article in The Wall Street Journal (WSJ) by Anna Wilde Mathews:

Several committee members said they worried that Ketek’s use in the milder conditions wasn’t justified. “The risk of the drug seems to me to make it not appropriate to keep on using” for those infections, said Carl Norden, a professor at the University of Medicine and Dentistry of New Jersey.

Additional recommendations by the advisory committee included a medication guide to be given to patients taking Ketek. The committees’ recommendations are non-binding, which means that the FDA is not bound to take the their advice, though it most often does.

Ketek has been associated with hepatoxicity (liver damage and/or failure), blurred vision, loss of consciousness, and exacerbation of myasthenia gravis.

Dr. David Ross, a former FDA employee who reviewed Ketek, said in an interview with CBS News, “Based upon the data available to me, I believe this drug is far more dangerous than other drugs that fight the same infections.”

Dr. Ross says he warned his superiors at the FDA that the drug was a “time bomb” and was shocked when Dr. Andrew Von Eschenbach, acting head of the FDA, told employees to keep their concerns internal and out of the press or risk losing their jobs. Dr. Ross quit the FDA in disgust.

Senator Charles Grassley is conducting a Senate Finance Committee investigation of Ketek and commented, “The leaders of an agency should not be holding a meeting to suggest dissenters should be kicked off the team, particularly when the life of American people are at stake.”