POPLINE Document Number: 108651
Corporate Author(s):
United States. Food and Drug Administration [FDA]
Source citation:
[Unpublished] 1992 Oct 29. [2] p.
Abstract:
Depo-Provera is a contraceptive drug which contains a synthetic hormone similar to the natural hormone progesterone. When injected into the muscle of the arm or buttock, the drug is gradually released into the bloodstream to prevent pregnancy for a period of three months. Depo-Provera was developed in the 1960s and has been approved for contraception in many countries. The Upjohn Company first submitted it for approval in the US in the 1970s. The US Food and Drug Administration (FDA) approved the drug for use in the US on October 29, 1992. Depo-Provera is more than 99% effective. It is available in 150 mg single dose vials from doctors and clinics and must be given on a regular basis to maintain contraceptive protection. If a patient decides to become pregnant, she simply discontinues the injections. As with any such products, however, the FDA advises patients to discuss the benefits and risks of Depo-Provera with their doctor or other health care professional before making a decision to use it. The most common side effects are menstrual irregularities and weight gain, while some patients may also 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. Furthermore, doctors are advised to not prescribe the drug in pregnant women due to concerns about low birth weight in babies exposed to the drug. Recent data also indicate that long-term use may contribute to osteoporosis.
Keywords:
United StatesIndex page
USFDA
Depo-Provera
Injectables
Side Effects
Contraindications
Contraceptive Agents, Side Effects
Women
Developed Countries
North America
Americas
USPHS
Government Agencies
Organizations
Medroxyprogesterone Acetate
Contraceptive Agents, Progestin
Contraceptive Agents, Female
Contraceptive Agents
Contraception
Family Planning
Contraceptive Methods
Treatment
Demographic Factors
Population