J&J Unit Subpoenaed for Topamax Documents ( )

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RARITAN, N.J., Dec 12, 2003 (AP Online via COMTEX) -- Johnson & Johnson's Ortho-McNeil Pharmaceutical Inc. unit on Friday said it received a subpoena from the U.S. attorney's office in Boston, requesting documents on the sales and marketing of its Topamax antiepilepsy drug.

The company said it is cooperating in responding to the subpoena.

The Food and Drug Administration approved Topamax in 1996 as a supplemental treatment for epilepsy, determining that its benefits outweighed potentially serious side effects such as myopia, glaucoma and kidney stones.

Ortho-McNeil is also seeking FDA approval for the drug as a treatment for migraines.

In July, the FDA ordered the company to provide more detailed information with Topamax, warning patients about decreased sweating and hypothermia.

Last month, a published report said some doctors prescribe Topamax for off-label uses, such as treating schizophrenia, bipolar disorder, depression, pain and nerve damage, and to help patients lose weight.

According to the report published by Knight Ridder Newspapers, 79 percent of Topamax prescriptions are for conditions the drug hasn't been approved to treat.

Ortho-McNeil said the company only promotes Topamax for approved uses. The drug had 2002 sales of $687 million.

Copyright 2003 Associated Press, All rights reserved