FDA lists drugs under safety probes

WASHINGTON Fri Sep 5, 2008 8:32pm BST

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WASHINGTON (Reuters) - U.S. health officials have disclosed safety probes into over 20 medicines by companies such as Eli Lilly and Co and Biogen Idec, a step required by Congress to address concerns the agency had been slow to warn of risks.

The U.S. Food and Drug Administration said on Friday that patients shouldn't overreact to the list of medicines undergoing safety probes following reports from doctors, patients and others of health problems.

Appearing on the list, agency officials said, does not mean the FDA has concluded that the drug caused the problem.

"We're telling the public really at the earliest stage what it is we're working on," said Dr. Gerald Dal Pan, director of the FDA office that monitors the safety of drugs after they reach the market.

The agency had been criticized as slow to alert patients about serious heart risks with Merck & Co's withdrawn arthritis pill Vioxx and reports of suicidal behavior in children taking antidepressants.

A law enacted last year required the FDA to tell the public each quarter about new safety data.

But agency officials voiced concern the preliminary information could cause patients to stop taking important drugs. "Don't stop taking your medicine," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Drugmakers also urged patients to keep taking their medicines unless a doctor tells them otherwise.

"The FDA needs to strive for communications that include the full context of the medication's benefits and risks," said Ken Johnson, a spokesman for the industry group Pharmaceutical Research and Manufacturers of America.

The list was posted at the FDA's website here .

SAFETY ISSUES

The safety issues were identified based on reports received from January through March 2008, the FDA said.

The list does not specify how many reports have been received and some problems have been previously made public.

Officials said they hoped the list would encourage more reports of any problems. Drugs on the list may be subject to future warnings or other actions from the FDA.

Shares of Celgene Corp fell more than 3 percent after the FDA identified reports of a skin disorder known as Stevens Johnson Syndrome in patients given the company's blood cancer drug Revlimid.

Celgene spokesman Brian Gill said a warning for Stevens Johnson Syndrome is already on the label for Thalomid, a predecessor to Revlimid, that is still used and is in the same class as Revlimid.

"We believe Celgene is one of the most vigilant companies out there when it comes to making sure drugs are used as safely as possible," he said.

The FDA also said it is evaluating reports of urinary retention with Eli Lilly's antidepressant Cymbalta, and skin melanoma with Biogen and Elan Corp's multiple sclerosis drug Tysabri.

Biogen spokeswoman Shannon Altimari said two cases of melanoma were reported in Tysabri patients in February in the New England Journal of Medicine.

"We don't believe there is an increase in melanoma with Tysabri," she said.

Lilly spokesman Charlie McAtee said the company was working with the FDA on the Cymbalta review. "Any information that helps patients understand their drugs, well we're all for that," he said.

GlaxoSmithKline Plc's cancer drug Tykerb also is being investigated after reports of liver toxicity, the FDA said. A "black box" warning about the issue was added to Tykerb's prescribing instructions in July, company spokeswoman Sarah Alspach said. A black box is the strongest type of warning for prescription drugs.

(Reporting by Susan Heavey, Lisa Richwine, Toni Clarke and Debra Sherman; editing by Tim Dobbyn)

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