Remove the black-box warning for depot medroxyprogesterone acetate!
Guidance about DMPA in the black box isn’t evidence-based, and the warning deprives women of long-term use of this safe and effective contraceptive
IN THIS ARTICLE
An opportunity to improve the health of women
The FDA appropriately takes action when a pharmaceutical company mislabels a product or promotes it in a way that isn’t based on sound evidence. Shouldn’t the FDA apply the same scientific standards to itself? Guidance included in DMPA’s black box is not evidence-based—and that reduces use of DMPA in US women and increases the potential for harm. Removing the black box would encourage use of this convenient, effective, and safe contraceptive22 and, in turn, improve the health of women and their families.
Again: We urge the FDA to promptly remove the black-box warning from labeling for DMPA.
Do you agree? We want to hear your opinion: Write to us in care of The Editors, at obg@qhc.com!
Long-acting reversible contraceptives are safe, effective for most women, study shows
But most use other methods because of lack of knowledge and cost concerns
Long-acting reversible contraceptives (LARC) are safe and effective for almost all women of reproductive age, according to an ACOG practice bulletin published in the July issue of Obstetrics & Gynecology.
Eve Espey, MD, MPH, and Rameet H. Singh, MD, MPH, from ACOG in Washington, DC, and colleagues compiled the latest recommendations on LARC use. The recommendations identify candidates for LARCs and help obstetricians and gynecologists manage LARC-related clinical issues.
The investigators reported that the LARC methods currently available have few contraindications, and that most women are eligible to use them. Intrauterine devices (IUDs) are suitable for women with a previous ectopic pregnancy and for women immediately after abortion or miscarriage. Routine antibiotic prophylaxis is not recommended before IUD insertion.
Copper IUD inserted up to 5 days after unprotected intercourse is the most effective method of postcoital contraception. The copper IUD can be used and remains effective for up to 10 continuous years. The levonorgestrel IUD may be effective for up to 7 years.
IUD complications are rare and include expulsion, method failure, and perforation. Implants can be safely inserted at any time after childbirth in non-breastfeeding women, or after 4 weeks for breastfeeding mothers. All LARC methods are safe for nulliparous women and adolescents.
The use of IUDs increased from 1.3% to 5.5% from 2002 to 2006-2008. Despite the benefits of LARCs, the majority of women choose other birth control methods, probably due to lack of knowledge about LARCs and cost concerns.
“LARC methods are the best tool we have to fight against unintended pregnancies, which currently account for 49% of US pregnancies each year,” Espey said in a statement.
Copyright © 2011 HealthDay. All rights reserved.
Has the FDA’s warning about DMPA had a chilling effect? Does the black-box warning prevent you from prescribing DMPA? Or does it alter your approach to using it? How?
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