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Contraception Corner

The Contraceptive Patch: Risks Versus Benefits

Emily M. Godfrey, MD, MPH; Scott J. Spear, MD

With the media turning its spotlight on adverse events purportedly associated with the transdermal contraceptive patch, now is a good time for physicians to review the data for scientific merit and ensure that patients have an accurate assessment of the risk/benefit picture.

Despite its established safety and efficacy, recent media reports have highlighted the risks of using the transdermal contraceptive patch. Therefore, it is imperative that physicians explain these risks in conjunction with the benefits, so women can make a fully informed choice concerning their contraception method.

Although the contraceptive patch has been clearly demonstrated to be effective and well accepted, negative headlines have caused confusion among women and health care providers alike regarding its safety. Given that a woman°s contraceptive needs are likely to vary over time, any actual or perceived restriction in choice of method may have unfortunate and unnecessary consequences, including unplanned pregnancy. Physicians can help to dispel misconceptions about the contraceptive patch by discussing the benefits as well as the risks in the context of individual patient needs.

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SAFETY AND EFFICACY

The transdermal contraceptive patch is applied once weekly for 3 consecutive weeks, followed by 1 patch-free week. Each patch delivers a daily dose of 150 mcg of norelgestromin (the active metabolite of norgestimate) and 20 mcg of ethinyl estradiol.1 Transdermal administration has several advantages. These include a constant plasma drug level, which prevents the peaks and troughs seen with oral contraceptives (OCs) and avoids first-pass hepatic metabolism, allowing for lower total hormone doses than oral formulations. Other advantages include favorable bleeding patterns, improved compliance, and reports of overall well-being.2,3 The efficacy of the transdermal patch has been shown to be comparable to OCs, although a post hoc analysis showed that the contraceptive patch may be less effective in women with body weight exceeding 198 lb (90 kg).4

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PERCEPTION OF RISK

The patch°s safety has been called into question because of reports that the deaths of several young women were related to its use. In addition, recent scientific studies lend credence to concerns about its safety profile. An open-label, randomized study published in 2005 found that when compared with a 30-mcg OC, the patch conferred a 60% higher systemic exposure to estrogen.5 In response to these findings, the FDA amended its prescribing information to include information about the increased levels of estrogen to which patch users are exposed as opposed to OC users.6

The extent to which this greater exposure causes complications such as venous thromboembolism (VTE) is unclear because of conflicting data. An epidemiologic chart review study found more than twice the risk of VTE for patch users compared with OC users.7 However, another study using data from managed health care plans with closely matched norgestimate OC and patch users found that the latter were no more likely to experience VTE (odds ratio, 0.9).8 This study was recently repeated for an additional 17 months, and again found no such risk (odds ratio, 1.1).9

Other misperceptions about the patch are due to confusion about the difference between an ¿adverse drug eventî and an ¿adverse drug reaction.î An adverse drug event occurs when an unwanted, negative, or harmful physical event may be drug-related or completely coincidental, whereas an adverse drug reaction occurs when the reaction is likely to be causally linked to the drug. Additionally, pharmaceutical adverse-event reporting has been shown to increase during the second year after FDA approval.10 When the events of a newer drug are compared with those of medications that have been on the market for many years (eg, OCs), the adverse-event reporting for the newer drug is likely to be particularly biased.

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COMMUNICATING RISK

It is important for all women to understand that no pregnancy, medication, or medical procedure is entirely without risk. As with any health care decision, clinicians should balance the patient’s individual risks of using the contraceptive patch against its potential benefits.

When discussing VTE, risk should be framed in the context of alternatives to the contraceptive patch. Patients should know that VTE is a relatively rare event that has been reported as a potential risk of all combined (estrogen-progestin) hormonal contraceptive methods. For appropriate candidates, excluding the patch as a contraceptive option may result in unintended pregnancy. In addition, VTE occurs in 50 to 300 of every 100,000 pregnancies, a risk higher than that associated with hormonal contraception.11 Before the contraceptive patch is prescribed, clinicians must consider independent risk factors for VTE ie, smoker over age 35, obesity, hypertension, underlying coagulation disorders, diabetes and migraine headaches with aura.12 The presence of these conditions should alert the clinician to consider using progestin-only or intrauterine methods.

Additionally, it may be helpful to place the relatively rare hormonal contraceptive risks in the context of common life activities such as driving a car, which carries a far greater chance of death and disability than does VTE in patch users. Comparisons like those noted in the Table provide some perspective on risk for patients in a real-life setting. It is also important to help women recognize that failure to use effective contraception may carry far more risk to life and health than the use of the contraceptive patch. Such choices should be made consciously and deliberately, and not as a result of rejecting a useful method that has received unfounded media attention. The media can help to inform women about contraceptive options and risks, but it is often far from objective and unbiased. In a frenzied media culture where “if it bleeds, it leads,” women are more likely to hear about the negative aspects of a particular method rather than its benefits or the true incidence of adverse outcomes.

Click to enlarge

TABLE. Risk Comparisons: Annual Risk of Death (per 100,000)13

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CONCLUSION

More than 5 million women worldwide have safely used transdermal contraception. Women who wish to initiate contraceptive use and who have no contraindications to combined hormonal contraception should be given the option of the contraceptive patch. Finally, women who are currently using the contraceptive patch successfully should not be discouraged from continuing use.

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Emily M. Godfrey, MD, MPH, is assistant professor, Department of Family Medicine, University of Illinois-Chicago. Scott J. Spear, MD, is affiliate medical director, Planned Parenthood of Arkansas and Eastern Oklahoma, Fayetteville, Arkansas.

References

1. Audet MC, Moreau M, Koltun WD, et al. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. JAMA. 2001;285(18):2347-2354.
2. Archer DF, Bigrigg A, Smallwood GH, Shangold GA, Creasy GW, Fisher AC. Assessment of compliance with a weekly contraceptive patch (Ortho Evra/Evra) among North American women. Fertil Steril. 2002;77(2 Suppl 2):S27-S31.
3. Urdl W, Apter D, Alperstein A, et al. Contraceptive efficacy, compliance and beyond: factors related to satisfaction with once-weekly transdermal compared with oral contraception. Eur J Obstet Gynecol. Reprod Biol. 2005;121(2):202-210.
4. Zieman M, Guillebaud J, Weisberg E, Shangold GA, Fisher AC, Creasy GW. Contraceptive efficacy and cycle control with the Ortho Evra/Evra transdermal system: the analysis of pooled data. Fertil Steril. 2002;77(2 Suppl 2):S13-S18.
5. van den Heuvel MW, van Bragt AJ, Alnabawy AK, Kaptein MC. Comparison of ethinylestradiol pharmacokinetics in three hormonal contraceptive formulations: the vaginal ring, the transdermal patch and an oral contraceptive. Contraception. 2005;72(3):168-174.
6. Ortho Evra (norelgestromin/ ethinyl estradiol). U.S. Food and Drug Administration web site. www.fda.gov/cder/drug/infopage/orthoevra/default.htm. Accessed September 27, 2007.
7. Cole JA, Norman H, Doherty M, Walker AM. Venous thromboembolism, myocardial infarction, and stroke among transdermal contraceptive system users. Obstet Gynecol. 2007;109(2 Pt 1):339-346.
8. Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2006;73(3):223-228.
9. Jick S, Kaye JA, Li L, Jick H. Further results on the risk of nonfatal venous thromboembolism in users of the contraceptive transdermal patch compared to users of oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol. Contraception. 2007;76(1):4-7.
10. Hartnell NR, Wilson JP. Replication of the Weber effect using postmarketing adverse event reports voluntarily submitted to the United States Food and Drug Administration. Pharmacotherapy. 2004;24(6): 743-749.
11. Barbour LA; ACOG Committee on Practice Bulletins-Obstetrics. ACOG practice bulletin. Thromboembolism in pregnancy. Int J Gynaecol Obstet. 2001;75(2):203-212.
12. Nightingale AL, Lawrenson RA, Simpson EL, Williams TJ, MacRae KD, Farmer RDT. The effects of age, body mass index, smoking and general health on the risk of venous thromboembolism in users of combined oral contraceptives. Eur J Contracept Reprod Health Care. 2000; 5 (4):265-74.
13. ARHP clinical proceedings. Helping your patients decide: making informed health choices about hormonal contraception. Association of Reproductive Health Professionals web site. July 2006. www.arhp.org/healthcareproviders/cme/onlinecme/RiskProjectCP/TOC.cfm. Accessed September 27, 2007.

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