Newspaper article St Louis Post-Dispatch (MO)

Health News

Newspaper article St Louis Post-Dispatch (MO)

Health News

Article excerpt

WASHINGTON

FDA Expected To Approve Use Of Drug Thalidomide

The Food and Drug Administration said Monday that it was on the threshold of approving the sale of thalidomide, the same drug that caused monstrous birth defects when taken as a sedative by pregnant women 35 years ago. The FDA wrote Celgene Corp. Monday that thalidomide would be approved to treat an inflammation in leprosy patients, once the company meets some final conditions, including safeguards against use of the drug by pregnant women. The leprosy inflammation is so rare that the FDA estimates the drug will be used by about 50 patients a year. Thalidomide 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. Some Americans got it overseas or in clinical trials. Because of the drug, about 12,000 babies worldwide were born with phocomelia, so called because their grossly misshapen hands and feet often resemble the flippers of seals. The FDA is considering requiring a picture of a phocomeliac child on the warning label. Thalidomide is being studied for use against AIDS-related wasting as well as ulcers, cancer, lupus, rheumatoid arthritis and other autoimmune diseases. The FDA agreed that use of the drug for such a wide variety of conditions would inevitably result in more thalidomide babies. The FDA's advisers recommended that it be sold under the tightest restrictions ever implemented for a U.S. drug. ESTROGEN THERAPY Study Links Treatment To Cholesterol Reduction Estrogen replacement therapy to help women through menopause also quickly reduces the amount of one type of so-called bad cholesterol, according to research at the Columbia University College of Physicians and Surgeons in New York. The researchers said estrogen therapy among a group of women over 50 reduced the amount of lipoprotein (a) in their blood by an average of 23 percent after three weeks. Although researchers have known for years that estrogen therapy generally reduces the risk of heart disease among women, the Columbia study gives new data on how fast the body's metabolism responds. …

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