FDA approves injectable contraceptive – Depo-Provera – Food and Drug Administration
Depo Provera, an injectable contraceptive drug, was approved by FDA last Oct. 29. It is more than 99 percent effective.
“This drug presents another long-term, effective option for women to prevent pregnancy,” said FDA Commissioner David A. Kessler, M.D. “As an injectable, given once every three months, Depo Provera eliminates problems related to missing a daily dose.”
The drug contains a synthetic hormone similar to the natural hormone progesterone. When injected into the muscle of the arm or buttock, the hormone is released into the bloodstream to prevent pregnancy. It must be given on a regular basis to effectively prevent pregnancy; women who decide to become pregnant can discontinue the injections.
FDA advises women interested in using Depo Provera to discuss the benefits and risks with their doctors. The most common side effects are menstrual irregularities and weight gain. Some women may experience headache, nervousness, abdominal pain, dizziness, weakness, or fatigue. The drug should not be used by women who have acute liver disease, unexplained vaginal bleeding, breast cancer, or blood clots in the legs, lungs or eyes.
Doctors are advised to rule out the possibility of an existing pregnancy in women requesting Depo Provera because of concerns about low birth weight in babies exposed to the drug. Recent data demonstrated that long-term use may contribute to a woman’s risk of developing osteoporosis.
Depo Provera was developed in the 1960s and has been approved for contraception in many other countries. The Upjohn Company of Kalamazoo, Mich., which will market the drug under the name Depo Provera Contraceptive Injection, first submitted it for approval in the United States in the 1970s. At that time, animal studies raised questions about its potential to cause breast cancer. Studies since then, both here and abroad, have found that the overall risk of cancer, including breast cancer in humans, is minimal, if it exists at all.
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