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Fda Ready To Approve Thalidomide Extreme Restrictions Planned To Avoid More Birth Defects

The Food and Drug Administration says it is poised to approve the sale of thalidomide, once the world’s most infamous drug.

The FDA wrote Celgene Corp. Monday that thalidomide would be approved to treat an agonizing inflammation in leprosy patients - once the company meets some final conditions, including tight restrictions aimed at avoiding the birth-defect horrors of the 1960s.

Celgene said the FDA’s “approvable letter” contained no surprise conditions, meaning final approval could come “in weeks rather than months,” said company spokesman Bob Butler.

Thalidomide was banned world-wide 35 years ago after it caused horrific birth defects in 12,000 babies. It had been sold as a sedative for pregnant women in 48 countries - but never in the United States, because an FDA scientist uncovered early signs of toxicity and blocked approval. Still, some Americans got it overseas or in clinical trials.

No one knew then that just one pill in early pregnancy could result in a baby with no limbs or with flipper-like arms and legs, and other defects.

Now it is making a comeback. The FDA’s scientific advisers recently said thalidomide can alleviate the agonizing leprosy condition called “erythema nodosum leprosum.”

Leprosy is so rare in the United States that the FDA estimates only about 50 patients a year would need that therapy. But doctors are expected to prescribe thalidomide for a wider range of conditions once it is on the market, including AIDS-related wasting.

The FDA and outside experts agree that use will inevitably result in more thalidomide babies. So the FDA’s advisers recommended that it be sold under the tightest restrictions ever implemented for a U.S. drug, even demanding that a photo of a child thalidomide victim be shown to every doctor who prescribes it and every patient who takes it.


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