The Food and Drug Administration on Thursday approved Depo Provera for use as a contraceptive that would prevent pregnancy for three months after its injection.
The FDA's decision followed the advice of an outside panel of scientists who recommended unanimously last June that the drug be allowed for use as a contraceptive.However, the FDA pointed out that the drug has a number of possible side effects, including weight gain and menstrual irregularities. It can also make women tired, weak, dizzy and nervous and cause headaches and abdominal pain.
"This drug presents another long-term effective option for women to prevent pregnancy," FDA Commissioner David Kessler said in a written statement.
"As an injectable, given once every three months, Depo Provera eliminates problems related to miss-ing a daily dose," Kessler said.
The FDA's Fertility and Maternal Health Drugs Advisory Committee heard a day of testimony on the drug's side effects before voting that its potential benefits outweighed the risks. The panel con-sidered whether the drug is scientifically linked to breast, liver or cervical cancer.
The drug, manufactured by Upjohn Co., already is used as a contraceptive in 90 countries.
Until Thursday it was approved for use in the United States only to treat endometrial and renal cancers. As a birth control agent, it inhibits the production of the hor-mone gonadotropin, preventing ovulation.
Since the late 1960s, the drug's use as a contraceptive in the United States has bounced back and forth between approval and a ban, based largely on animal studies that suggest a link to cancers of the cervix, liver and breast. More recent studies, though, have indicated that the link may not be as strong as previously believed.