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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