Wednesday, November 17, 2004

FDA Issues Strong Warning on Depo-Provera

'Black Box' Warning Ordered On Pfizer's Contraceptive

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.