In Our Control (21 page)

In recent years, many doctors and health professionals have argued that the risk of Depo-Provera to bones has been overstated. The problem, these people explain, is that while no one is disputing that the drug causes loss of bone density,
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what is up for debate is the recoverability of that mass. Some data suggests that information on bones isn’t as bad as was originally feared, especially when it comes to building back bone after giving up Depo. According to these sources, the mass is regainable. A review article in the journal
Contraception
studied the bone mineral densities (BMD) of postmenopausal women after they had stopped using Depo, the BMD of premenopausal women after they had stopped, and the BMD of teenagers after they had stopped. The postmenopausal women had bone
densities on par with nonusers and didn’t have significantly increased fracture rates.
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Both premenopausal women and teenagers showed partial to full recovery of losses after discontinuing use of Depo.
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While the FDA has recommended limiting use of Depo-Provera to two years, other organizations disagree.
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The World Health Organization (which helped to develop the drug), the American Society for Adolescent Medicine, and the Society of Obstetricians and Gynecologists of Canada have argued that women between the ages of eighteen and forty-five should use the method for as long as they want, as long as they are counseled on maintaining good bone health (for example, getting calcium and vitamin D and engaging in weight-bearing exercise).

Much more research in this area is needed before a conclusion can be made, but it would be worthwhile to conduct more studies on whether women regain bone mass after going off the shots. It is distressing that so many health professionals continue to champion this method for teenagers and twenty-somethings while this very serious question remains unresolved. Women face dramatically different sets of choices that impact their readiness to engage in a certain method’s set of risks, but it is hard to argue that if faced with equally effective methods (Depo and the Pill), women wouldn’t choose the one with a better safety profile. Of course, studies show that teenagers don’t always do very well with the Pill (let alone barriers). They forget to take it and get confused about accounting for missed pills, and they have trouble getting new packs. These realities of women’s lives must figure into the balance.

This gets to the heart of some serious (and not easily answered) questions about what constitutes good contraceptive health. While pregnancy prevention is indeed an important outcome to consider, it must always be measured against other problems that may be equally serious. The problem with Depo is that the population who might want its distinct advantages—very young women—is the one most affected by one of its serious problems: bone loss. So while near perfect pregnancy prevention and less day-to-day responsibility in attaining it may be most important to a woman in her teens or early twenties, this is precisely the moment when her choice can be damaging.

With young women in particular, health care professionals have a tendency to set up an all-or-nothing scenario in which the risks of a
contraceptive are cast favorably against the health problems that proliferate with pregnancy. This is a faulty comparison, since there are many available birth control methods to choose from. It is certainly true that teenagers are particularly vulnerable to the negative effects of unplanned pregnancy. But it is imperative to balance efforts to find reliable but side effect–prone contraceptives with efforts to empower young women to use healthier available methods correctly. If regular oral contraceptives prove less dangerous (yet more prone to user failure) than alternative distribution methods, then perhaps we should work to help young women use the Pill correctly rather than assuming educational efforts will get us nowhere and asking young women to bear the additional health burdens.

Other side effects that seem more pronounced in Depo-Provera than a typical combined oral contraceptive pill are irregular bleeding and weight gain. In a way, this injectable is the first menstrual suppression drug. Like later pills such as Seasonale, Depo-Provera creates unpredictable bleeding that resolves for many (but not all) patients with continued use. As with menstrual suppressants, most women will have some spotting or bleeding in the first month after receiving as injection, and many women (50 percent) will have breakthrough bleeding in early cycles. This declines during the first year of use, and after twenty-four months, 68 percent of women will have ceased to bleed.
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With Depo-SubQ, more women continue to experience bleeding or spotting over the course of the first year of use. Like other menstrual suppressants, it is a good idea to take a pregnancy test each month to ensure that you aren’t pregnant. While pregnancy is unlikely, continued exposure to hormones can harm a developing fetus, so it’s good to be on the safe side.

Many women using Depo-Provera gain some weight on the drug.
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Reports vary, but users probably put on an average of 5 pounds in their first year of use, and this amount goes up to 8 pounds after two years and 13.8 pounds after three years.
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Weight gain with Depo-SubQ was slightly lower, but essentially the same.
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Who is likely to gain weight remains an open question. Authors of one study note, “It is a concern that women who were not obese at the start of the study were twice as likely to become obese over the next three years if they selected DMPA over NH (non-hormonal) contraception.”
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Others believe obese women are more vulnerable to experience weight gain with this method, especially during
the first year of use.
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While scientists continue to explore which women will put on weight, they have found that those who do are increasing fat in the body, not just retaining fluids.
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Women who switch to nonhormonal methods lose some of the weight, while those who switch to the Pill may continue to gain a very small amount.
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Women using Depo seem to gain more weight than those using other hormonal contraceptives, including traditional oral contraceptives and implants.
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The latter is important because it seems to point to the particular progestin, rather than progestin-only contraception, as the cause of this particular problem. Since it remains difficult to predict who will have weight gain, researchers at the University of Texas argue that closely monitoring changes in pounds over the first six months of use can help to curtail this problem.
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It is possible that progestin-only contraception is better for women with cardiac problems, but more research is needed on this subject.
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Most women take slightly longer to return to fertility after stopping their shots, and there have been anecdotal reports of permanent loss of ovulation,
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but most women will resume fertility within ten months.
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Because many of the problems associated with Depo-Provera are attributed, in one way or another, to progestin, there is some thought that adding estrogen to the injection might lessen some of its side effects. A 2008
Cochrane Database of Systematic Reviews
review found that combination injectables had smaller rates of discontinuation of use due to side effects.
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Estrogen/progestin combination shots might have the potential to mitigate the bone problem seen in the progestin-only formula, as well as improving irregular bleeding patterns, although this remains uncertain.

Another important thing to mention about MPA: it is part of a drug called Prempro that was included in the estrogen and progestin arm of the massive Women’s Health Initiative trial. Prempro also contains Premarin, an equine estrogen not found in birth control pills. When the trial was prematurely halted in 2002, it was because patients taking Prempro had more heart attacks, breast cancer, strokes, pulmonary embolisms, and blood clots than women taking a placebo. The older age of the participants in the WHI trial undoubtedly makes a big difference in how hormones worked in their bodies, but the results of this valuable study raise a lot of questions about how our knowledge of hormone drugs is still evolving in profound ways.

Skin-Deep: The Contraceptive Patch and the Vaginal Ring

Twenty-first century alternative distribution methods have provided hope for drugmakers burned by the struggles of nearly thirty years of trying to develop nonpill hormonal contraceptives. Transdermal contraception and vaginal contraception require less patient adherence than “once-a-day” pills, and they are relatively expensive—and therefore profitable for drugmakers. Like Depo-Provera or Norplant, these devices don’t require the patient to monitor them every day. Like the Pill, they must be replaced at significant cost each month. And unlike Depo-Provera or Implanon, patients apply and remove these methods themselves.

In the 1990s, the success of antismoking medicines popularized the idea that you could take pharmaceuticals through a skin patch. Ortho Evra, first approved by the FDA in 2002, is currently the only available transdermal contraceptive. With this method, a patient receives three patches each month. Starting no later than the fifth day of the menstrual cycle,
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she applies one of the patches to her buttock, lower abdomen, upper arm, or upper torso (notably the breast is left out because of concerns about cancer). Studies have found no difference in the speed or concentration with which the hormones are absorbed based on where on the body the patch is placed.
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The patch is made of three layers: a flesh-colored film that protects the chemical and adhesive parts, a sticky layer that also contains the active hormones (a total of 750 μg of ethinyl estradiol and 6,000 μg of norelgestromin, a progestin, with 20 μg of ethinyl estradiol and 150 μg of norelgestromin released daily),
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and a backing that is removed before application.
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This item is surprisingly resilient: the patch can be worn in the shower, swimming pool, and steam room. You can’t douse it in lotion, and you must try to keep the area free from toiletries and cosmetic products, particularly those with oil bases. At the end of seven days, the patch is removed and another applied immediately in its place. The patch is left off every fourth week so that the patient has withdrawal bleeding, after which the cycle repeats again. It is very important to make sure that the patch stays on: hormones won’t be properly absorbed in the body if the patch becomes partially or completely detached. Only about 5 percent of patches come loose,
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but if this happens, replace it immediately. If you forget to switch your patch, it is reassuring to know that many
doctors believe it is more forgiving of dosing errors that the Pill, so even if mistakes are made, you are less likely to get pregnant,
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but obviously you shouldn’t rely on this.

It is very common to have a skin reaction to the patch: one study found that 14 percent of women experienced this side effect,
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while another suggested it might be as high as 20 percent.
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Transdermal contraception prevents pregnancy with about the same efficacy as the birth control pill, although recent studies suggest it may be slightly less effective in obese women.
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Side effects are similar to those found with traditional OCs, but patch users have more breast tenderness (especially in the first months of use) and nausea.
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On the positive side, patch users had less irregular bleeding than those on the Pill.
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Even though women profess greater satisfaction with transdermal methods than with oral contraception, they tend to go off the patch just as often, and early discontinuation is higher.

After approval of the patch, hopes were high that it might prove safer than older hormonal alternatives. But it turns out that despite lower dosing, women absorb higher concentrations of estrogen with the patch than with the Pill—as much as 60 percent more. In the late fall of 2005, the FDA responded to this emerging information by issuing an update warning that using Ortho Evra could cause greater estrogen exposure and possibly more blood clots.
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Two early studies found conflicting results: one concluded that use of the patch didn’t actually increase blood clotting,
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while another found that it caused a twofold increase in risk.
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The first study, which found no increased risk, was conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) in cooperation with Johnson & Johnson, the drugmaker. Despite the mixed results, the FDA changed Ortho Evra’s label to let patients know that they might have a higher risk of blood clotting with the patch. In 2008, the FDA revised the label again when a later study by BCDSP also found more blood clots with Ortho Evra than with birth control pills.
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All told, it is estimated that as many as forty women died between 2002 and 2006 using the patch before FDA labeling reflected an increased danger.
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