Expert Commentary

Remove the black-box warning for depot medroxyprogesterone acetate!

OBG Manag. 2011 August;23(8):6-9

References

1. Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott SM. Change in bone mineral density among adolescent women using and discontinuing depot medroxyprogesterone acetate contraception. Arch Pediatric Adolesc Med. 2005;159(2):139-144.

2. Harel Z, Johnson CC, Gold MA, et al. Recovery of bone mineral density in adolescents following the use of depot medroxyprogesterone acetate contraceptive injections. Contraception. 2010;81(4):281-291.

3. Scholes D, LaCroix AZ, Ichikawa LE, Barlow WE, Ott SM. Injectable hormone contraception and bone density: Results from a prospective study. Epidemiology. 2002;13(5):581-7.

4. Kaunitz AM, Miller PD, Rice VM, Ross D, McClung MR. Bone mineral density in women aged 25-35 years receiving depot medroxyprogesterone acetate: recovery following discontinuation. Contraception. 2006;74(2):90-99.

5. Schnatz PF, Barker KG, Marakovits KA, O’Sullivan DM. Effects of age at first pregnancy and breast-feeding on the development of postmenopausal osteoporosis. Menopause. 2010;17(6):1161-1166.

6. World Health Organization WHO Epidemiological Record No. 35: WHO statement on hormonal contraception and bone health. Geneva Switzerland: World Health Organization. 2005;80(35):302-304.

7. Grimes DA, Schulz KF. Surrogate end points in clinical research: hazardous to your health. Obstet Gynecol. 2005;105(5 pt 1):1114-1118.

8. Grimes DA, Schulz KF, Raymond EG. Surrogate end points in women’s health research: science protoscience, and pseudoscience. Fertil Steril. 2010;93(6):1731-1734.

9. Shulman LP, Bateman LH, Creinin MD, et al. Surrogate markers, emboldened and boxed warnings, and an expanding culture of misinformation: evidence-based clinical science should guide FDA decision making about product labeling. Contraception. 2006;73(5):440-442.

10. Cundy T, Cornish J, Roberts H, Reid IR. Menopausal bone loss in long-term users of depot medroxyprogesterone acetate contraception. Am J Obstet Gynecol. 2002;186(5):978-983.

11. Orr-Walker BJ, Evans MC, Ames RW, Clearwater JM, Cundy T, Reid IR. The effect of past use of the injectable contraceptive depot medroxyprogesterone acetate on bone mineral density in normal post-menopausal women. Clin Endocrinol (Oxf). 1998;49(5):615-618.

12. Viola AS, Castro S, Marchi NM, Bahamondes MV, Viola CFM, Bahamondes L. Long-term assessment of forearm bone mineral density in postmenopausal former users of depot medroxyprogesterone acetate. Contraception. In press.

13. Vestergaard P, Rejnmark L, Mosekilde L. The effects of depot medroxyprogesterone acetate and intrauterine device use on fracture risk in Danish women. Contraception. 2008;78(6):459-464.

14. Meier C, Brauchli YB, Jick SS, Kraenzlin ME, Meier CR. Use of depot medroxyprogesterone acetate and fracture risk. J Clin Endocrin Metab. 2010;95(11):4909-4916.

15. Kaunitz AM, Harel Z, Bone H, et al. Retrospective cohort study of DMPA and fractures in reproductive age women. Paper presented at: Association of Reproductive Health Professional Annual Meeting; September 24, 2010; Atlanta, GA.

16. Mosher WD, Jones J. Use of contraception in the United States: 1982-2008. National Center for Health Statistics. Vital Health Stat 23. 2010;23(29):1-44.

17. Paschall S, Kaunitz AM. Depo-Provera and skeletal health: A survey of Florida obstetrics and gynecologist physicians. Contraception. 2008;78(5):370-376.

18. American College of Obstetricians and Gynecologists Committee on Gynecologic Practice. ACOG Committee Opinion No. 415: Depot medroxyprogesterone acetate and bone effects. Obstet Gynecol. 2008;112(3):727-730.

19. Cromer BA, Scholes D, Berenson A, Cundy T, Clark MK, Kaunitz AM; Society for Adolescent Medicine. Depot medroxyprogesterone acetate and bone mineral density in adolescent—the black box warning: A position paper of the Society for Adolescent Medicine. J Adolesc Health. 2006;39(2):296-301.

20. Black A; Ad Hoc DMPA Committee of the Society of Obstetricians and Gynaecologists of Canada. Canadian contraception consensus: update on depot medroxyprogesterone acetate (DMPA). J Obstet Gynaecol Can. 2006;28(4):305-313.

21. Centers for Disease Control and Prevention. US medical eligibility criteria contraceptive use 2010. MMWR. 2010;59 (RR04);1:6.

22. Kaunitz AM, Grimes DA. Removing the black box warning for depot medroxyprogesterone acetate [published online ahead of print February 21 2011]. Contraception. doi:10.1016/j.contraception.2011.01.009.

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!

NEWS FROM THE MEDICAL LITERATURE

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.

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?
To tell us, click here