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Blumenthal Asks FDA to Strengthen Warnings for Anticancer Drug

May 4, 2005 | AP State Attorney General Richard Blumenthal on Wednesday asked federal regulators to strengthen warnings to doctors and patients about what he said are blood-clotting risks associated with a drug used to treat a form of cancer.

A petition he submitted to the U.S. Food and Drug Administration also asks the agency to consider price controls on Thalomid, which is sold by Celgene Corp. of Summit, N.J. Thalomid, a compound from the drug thalidomide, has become the most popular treatment for the bone cancer multiple myeloma.

"Powerful and popular as this anticancer drug may be, it can have lethal side effects dangers that the FDA has disregarded and the manufacturer has downplayed," Blumenthal said.

Labeling says patients treated with Thalomid may have a greater risk of developing blood clots, Blumenthal said. The labeling says it is not known if combining Thalomid with other medications are a contributing factor to blood clots, he said.

Blumenthal's petition seeks stronger warning and safety labeling to inform doctors and patients about the dangers of blood clotting when the drug is used to treat cancer, particularly in combination with chemotherapy drugs and to advise them that blood thinners may reduce such risk.

A spokeswoman for the FDA said the agency will review the petition. It has 180 days to respond to Blumenthal.

Brian Gill, a spokesman for Celgene, said Thalomid's label and a product insert "clearly communicate concerns or warnings around the potential" for so-called "thrombotic events," or the obstruction of a blood vessel by a clot.

In combination with dexamethasone, an anti-inflammatory drug also used in cancer treatment, Thalomid has been recommended at international medical meetings and in peer-reviewed journals, he said. In 2003, the National Comprehensive Cancer Network, which coordinates cancer drug tests, recommended that newly diagnosed myeloma patients take Thalomid and dexamethasone.

Blumenthal also said the FDA should consider imposing price controls on Thalomid because its rising cost may force patients to buy the drug overseas or on the Internet, bypassing controls intended to prevent birth defects.

Gill said the drug has risen in price since its approval in 1998. He did not say what its price is, but said Celgene had been unprofitable for 17 of its 19 years in business.

Thalomid was approved by the FDA in 1998 to treat leprosy symptoms, and doctors may prescribe it for other uses.

Steady revenue from Thalomid has helped propel Celgene into one of the world's top 10 biotech companies and bankrolled its research on treatments for cancer and inflammatory disorders.

Thalidomide, which caused facial and limb deformities in 12,000 babies overseas, was banned in 1962.

Brian Durie, a physician at Cedars Sinai Medical Center in Los Angeles and chairman of the International Myeloma Foundation, said he was a "little surprised" at Blumenthal's petition.

"There's a high level of awareness of the clotting issue with Thalomid," he said. "If this is a really critical issue, we'd be putting it out on listserves (asking) 'Do you know there's a clotting issue?"'

Thalomid is a "remarkably effective drug" for myeloma, achieving a remission of a few years, or doubling the number of years a patient can live with the disease, Durie said.

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