Provera medicine
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Depo-Provera: A Comprehensive Overview
Introduction to Depo-Provera
Depo-Provera is a widely used injectable contraceptive that has been available in the United States for over a decade and globally for around 40 years. It is known for its high efficacy in preventing pregnancy, with a failure rate of 0.2-0.6 per 100 woman-years. The drug is administered intramuscularly every three months, making it a convenient option for many women who may struggle with daily contraceptive methods.
Historical Context and Approval
Depo-Provera was initially approved in 1960 for treating endometriosis and recurring pregnancy loss, but it was later found to be ineffective for these conditions. However, its potential as a long-term contraceptive was discovered, leading to its approval by the FDA in 1992. Before its official approval, Depo-Provera was used off-label in various settings, including family planning clinics and as a court-ordered treatment for sex offenders.
Efficacy and Pharmacokinetics
Depo-Provera is highly effective in suppressing ovulation. A new lower-dose formulation (104 mg/0.65 mL) has been developed for subcutaneous injection, which is easier to administer and more tolerable while maintaining its efficacy. This formulation suppresses ovulation for more than 13 weeks and is not affected by body mass index or race. The median time for return to ovulation is approximately 30 weeks, with a 97.4% cumulative rate of return to ovulation at 12 months.
Health Risks and Side Effects
While Depo-Provera is effective, it comes with several risks and side effects. These include weight gain, heavy or irregular menstrual bleeding, bone loss, loss of libido, depression, and an increased risk of breast cancer . The drug's long-term safety has been a subject of scrutiny, but extensive clinical experience has generally established its safety profile.
Controversies and Legal Issues
Depo-Provera has been the center of numerous controversies and legal battles. In the UK, the Health Minister overruled the Committee on Safety of Medicines' recommendation to approve the drug, citing concerns about informed consent and the balance of benefits and risks. In the United States, the FDA initially refused to approve Depo-Provera due to studies showing it caused breast tumors in Beagle dogs and Rhesus monkeys. However, subsequent studies, including a 12-year WHO multinational study, have reassured its safety, particularly concerning breast cancer risk.
Use in Special Populations
Depo-Provera has been used in various special populations, including institutionalized women, disabled women, teenagers, poor women, and women of color, due to its ease of administration. It has also been used in the criminal justice system to manage sexual deviance in male sex offenders, although this practice has raised significant ethical and constitutional concerns.
Non-Contraceptive Benefits
In addition to its contraceptive benefits, Depo-Provera has been shown to decrease the risk of ovarian and endometrial cancer. It is particularly beneficial in developing countries where compliance with daily contraceptive methods is challenging, and it can help increase hemoglobin levels in women suffering from anemia.
Conclusion
Depo-Provera remains a highly effective and convenient contraceptive option with a complex history of use, approval, and controversy. While it offers significant benefits, particularly in terms of long-term contraception and non-contraceptive health benefits, it also poses several risks and side effects that need to be carefully managed. Ongoing research and regulatory scrutiny continue to shape its use and acceptance worldwide.
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