WASHINGTON -- A federal advisory panel recommended yesterday that the government approve Depo-Provera, a highly effective but controversial contraceptive that provides three months of protection with a single injection.
The drug, manufactured by the Upjohn Co. of Kalamazoo, Mich., is already marketed in more than 90 countries -- including the Britain, Germany, France, New Zealand, and Sweden -- and has been used by an estimated 30 million women worldwide.
But it has repeatedly failed to win approval in the United States for the past 25 years because of concerns, raised in animal studies, that the drug increased the risk of cancers of the cervix, liver and breast.
Members of the Food and Drug Administration's advisory committee on fertility and maternal health drugs said they found the evidence from years of use abroad compelling enough to unanimously recommend that the drug finally be licensed here.
The FDA is not bound by the recommendations of its advisory committees, but it rarely overrules their advice.
The drug is already available in the United States for the treatment of renal and endometrial cancer.
A series of studies initiated in 1979 by the World Health Organization on more than 11,000 women has shown that the risk of breast cancer for Depo-Provera users appears to be no greater than that associated with birth control pills.
"When it has been used in 90 countries and used by so many millions of women -- if it caused anything dramatic, we'd have some clues," said Dr. Barbara S. Hulka, chairwoman of the panel and a professor of epidemiology at the University of North Carolina School of Public Health.
"We don't see any clues of any serious effects," she added. "The WHO study was . . . reassuring."
Depo-Provera is known generically as depot-medroxyprogesterone acetate, or DMPA.
It was estimated by one physician at the meeting to cost about $120 a year, considered modest for a contraceptive.
The drug's side effects include weight gain, absence of menstrual periods, and delayed fertility once the drug is stopped. Some studies have also shown a connection to osteoporosis and low birth weight associated with accidental pregnancies.
The committee called for additional research into the drug's association with osteoporosis and low birth weight babies.
The drug has also been the subject of legal controversy because it could be used for so-called "chemical castration" sentences that judges have considered imposing on sex offenders.