Caution with Ketek in Myasthenia Gravis Patients

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Aventis Urges Extreme Caution With Ketek in Patients With Myasthenia Gravis

By Ned Stafford

HAMBURG, Germany (Reuters Health) Apr 15 - The German subsidiary of drugs group Aventis has issued a warning to physicians to use extreme caution with its new antibiotic Ketek (telithromycin) in patients with myasthenia gravis.

The warning, from Aventis Pharma Deutschland, said that recently several patients who had used Ketek for respiratory infections had experienced exacerbation in already diagnosed myasthenia gravis. One patient died, according to the warning, which was dated Monday but publicly released Tuesday by the Drug Commission of the German Medical Association.

In the reported cases, the warning said, myasthenia gravis patients experienced an intensification of muscle weakness, dyspnea or "heavy acute breathing insufficiency" within hours of taking Ketek.

Ketek, the first in a new class of antibiotic, has been sold since 2001 in some European and Latin American countries, but has not yet been approved in the U.S.

The FDA had been widely expected to approve Ketek in January after a panel of agency advisers backed the drug to treat certain respiratory infections resistant to treatment with penicillin or macrolide antibiotics. But the launch of Ketek in the US was delayed following receipt of a second so-called "approvable letter" from the FDA requesting extra analysis of data.

An Aventis spokeswoman at headquarters in Strasbourg, France, told Reuters Health Tuesday the company did not expect the myasthenia gravis warning to hurt chances of FDA approval. She said myasthenia gravis is an extremely rare disease

She said that Aventis does not recommend Ketek for patients with myasthenia gravis, but if no alternative is available, patients should be closely monitored. At the first sign of exacerbation of myasthenia gravis, Ketek usage should be stopped.

The Aventis subsidiary in Germany was the only one thus far to have issued a warning to doctors, she said. Warnings for doctors in other nations will be issued by the end of the week, she said.

She also said that a warning for myasthenia gravis had not previously been included in the drug's dosage and use information, but will now be added.

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