J&J Unit Subpoenaed for Topamax Documents
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
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.
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