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Pfizer's Contraceptive Can Weaken Bones

The U.S. Food and Drug Administration ordered a strong, new warning for Pfizer Inc.'s injectable contraceptive called Depo-Provera, saying it could permanently weaken bones.

The agency called for the strongest warning possible -- a so-called "black box" -- for the drug's packaging, saying that long-term use of the drug can lead to a loss of bone density. But the FDA also said the drug is still safe and effective.

Patients should only use the drug, which is injected about every 13 weeks, if other types of birth control are not an option or are "inadequate," FDA officials said in a statement.

The drug's label already includes other, less severe cautions, advising against its use in women who have breast cancer, liver problems, a past stroke or blood clots in the legs.

Agency officials said the new warning came after the company and the FDA analyzed data "that clarified the drug's long-term effects on bone density," but they did not give specifics.

Pfizer shares closed up 67 cents, or 2.45 percent, at $27.99 in late afternoon trade on Wednesday on the New York Stock Exchange.

Reference Source 89
November 18, 2004


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