Warning Ordered On Pfizer's Contraceptive

'Black Box' Warning Ordered On Pfizer's Contraceptive

11-17-4


WASHINGTON (Reuters) -- The U.S. Food and Drug Administration on Wednesday 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.

Copyright © 2004 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. http://story.news.yahoo.com/news?tmpl=story&cid=571&ncid= 751&e=1&u=/nm/20041117/hl_nm/health_pfizer_contraceptive_dc


Tweet