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FDA Miffed Over Letter On Schizophrenia Drug

Apr 28, 2004 | Star Ledger

Federal regulators yesterday chided Janssen Pharmaceutica, part of the Johnson & Johnson health-care empire, for including misleading information in a letter to physicians about the health risks associated with its schizophrenia medicine, Risperdal.

Janssen minimized the diabetic risks associated with the drug, and without supporting data, claimed Risperdal is safer than similar medicines, regulators said in a warning to the company. The letter went to 600,000 health-care providers.

"The letter misleadingly omits material information about Risperdal, minimizes the potentially fatal risks associated with the drug and claims superior safety without adequate substantiation," the FDA said in its warning.

The agency's rebuke puts the spotlight on one of Johnson & Johnson's top-selling medicines, which continues to vie against rivals in the intensely competitive market for anti-psychotic drugs. The market is expected to double in sales, reaching as much as $11.2 billion, by 2006.

Johnson & Johnson, which is based in New Brunswick, earlier this month credited sales of Risperdal with helping to lift its prescription drug sales to $2.49 billion for the first quarter of 2004.

"We take the FDA's letter seriously, and we are working with the agency to address their concerns as quickly as possible," company spokeswoman Carol Goodrich said.

Janssen was ordered to immediately stop distributing promotional material containing the claims and to detail a plan to issue accurate information. The company has until Monday to respond to the FDA's request.

"It's not often that a company dances around an issue like this," said Arthur Levin, director of the Center for Medical Consumers, a patient advocacy group in New York City.

"It's dangerous," he said, "The question is why aren't they being fined? This is entirely inappropriate."

Last year, the Food and Drug Administration instructed Janssen and five other companies that sell similar anti-psychotic medicines to change their product labeling to include warnings about the risk of diabetic-related adverse events, including the possibility of coma and death.

The FDA based its decision on a review of clinical study data, post-marketing reports and published case studies, among other things.

Janssen complied with the requirement, and the FDA subsequently approved the language proposed by Janssen for its labeling. Then, as a way of alerting physicians to the labeling changes, regulators asked Janssen and the other companies to issue letters to health-care providers.

The letter, the FDA said, contradicts the warning in the revised product labeling.

Linda Gochfeld, a Princeton psychiatrist, said most doctors were aware of the side effects even without the letter.

"With every drug, you're weighing the beneficial effects against the side effects," she said.

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