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Carter-Wallace Issues Epilepsy Drug Warning

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From Associated Press

Drug maker Carter-Wallace Inc. told doctors Monday to take their patients off the epilepsy drug Felbatol after two people who took it died from a serious form of anemia, a development that led to the company’s stock losing a third of its value.

The Food and Drug Administration and the company said 10 patients contracted a rare and frequently fatal affliction called aplastic anemia, in which the bone marrow stops making blood cells. Nine of the 10 were in the United States and two died, the FDA said.

Shares in New York-based Carter-Wallace dropped $4.875, or 31%, to $10.75 on the New York Stock Exchange on Monday.

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Felbatol was introduced in September, the first new drug to help prevent epileptic seizures in 15 years. About 100,000 of the 2.5 million epileptics in this country use it, officials at the Epilepsy Foundation of America said.

Carter-Wallace said it has sent a letter to about 240,000 doctors recommending immediate withdrawal of the drug unless the doctor feels that not using the drug would pose a more serious risk to the patient.

The FDA and the company urged patients against halting their use of the drug unless their doctor tells them to do so.

Doctors generally discourage sudden withdrawal from anti-epileptic drugs because of the chance that the frequency of seizures will increase.

“We strongly recommend that patients consult their physician as soon as possible, but it is critical that they not discontinue the drug on their own due to the risk of seizures,” FDA Commissioner David Kessler said in a statement.

Carter-Wallace will “convene a panel of experts to discuss the entire subject in the near future,” said Lois Brown, a spokeswoman for the company.

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She said the company is not recalling the drug, whose chemical name is felbamate.

This is the second time this year that the company has had trouble with one of its popular products.

In June, Carter-Wallace said it would stop selling its cough and cold medicine Organidine, after the FDA found that it produced cancer in rats, said Arvind Desai, an analyst with Mehta & Isaly in New York.

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