German court lifts OC prescription ban
With the recent ruling by a German administrative court that lifted the prescription ban against third-generation oral contraceptives (OCs) for first-time users under age 30, health care providers may be moving toward the resolution of what has been termed "the pill scare."
When a notice was issued in late 1995 by the British Committee on the Safety of Medicines on the increased risk of venous thromboembolism (VTE) with third-generation pills containing gestodene or desogestrel, controversy raged throughout Europe. The committee based its findings on then-unpublished data from three large studies.1,2,3,4,5
The German health regulatory agency soon followed suit and declared that third-generation pills could not be prescribed to first-time users under 30. NV Organon, the European parent of Organon USA in West Orange, NJ, filed suit against the German agency.
Only two pills sold in the United States contain desogestrel: Desogen from Organon and Ortho-Cept from Ortho-McNeil Pharmaceuticals in Raritan, NJ. No pills containing gestodene are marketed in the United States. Although the U.S. Food and Drug Administration issued a statement that the risk of VTE was not sufficient to warrant switching patients from desogestrel pills, many U.S. clinicians moved away from prescribing the pills, particularly for new-start patients.
The German court, after examining scientific evidence and medical testimony, ruled in Decem-ber 1997 that the prescription ban be lifted.
What does this mean for U.S. clinicians? For providers such as Robert Rebar, MD, professor and chairman of the department of obstetrics and gynecology at the University of Cincinnati College of Medicine, the German court’s action only serves to affirm his continued used of such third-generation pills.
"I have continued to use [desogestrel OCs] for patients whom I see who admittedly are a small group most who have had problems with other OCs when they came to see me," he says. "It has not changed my practicing patterns at all. The information that now comes from Germany, if anything, lends further support to my decision."
David Archer, MD, professor of OB/GYN at the Jones Institute for Reproductive Medicine at the Eastern Virginia Medical School in Norfolk, sees no contraindication to using desogestrel in first-start patients. Some side effects, such as breast discomfort and bloating, are less with the desogestrel products, he observes. Desogestrel also offers a more lipid-neutral profile than other products.
When clinical trials of third-generation OCs were held at Rebar’s facility, patients who used the new progestins clearly liked them better than contraceptives they had used in the past. "The major comment they made was that they felt better on [desogestrel] than other contraceptives," Rebar says.
Archer concurs with the German court’s ruling that medical evidence did not warrant a prescription ban for first-time users. "From the standpoint of the physician, I think the German decision was excellent because I don’t think the weight of the evidence allows you to make the distinction that there’s a tremendously or significantly increased risk for this starting group of young women."
When women present for the first time as possible oral contraceptive users, a proportion of them are going to be at risk for deep vein thrombosis (DVT) because they have never been on birth control pills before, Archer observes. It is possible that the OC could trigger an underlying medical problem and cause a DVT, thereby slightly elevating the risk in first-start patients.
Women who have used third-generation pills successfully for years have only a slightly increased risk of DVT because all of the women who were susceptible are no longer using the pills, explains Carolyn Westhoff, MD, MSc, associate professor in the department of OB/GYN and School of Public Health – Epidemiology at Columbia University in New York City.
In an epidemiological study, the newest pills may look riskier because there will be more new users on such pills, she says. The desogestrel and gestodene pills looked worse in the original analyses because they had many new users, she points out. A recent study published in Contraception, however, re-examined data from one of the original studies and concluded that second- and third-generation pills are associated with identical risks of VTE when they are prescribed to first- time users.6
This point of view suggests that any new user of any pill will have the excess risk for VTE early, Westhoff notes. In previous studies, epidemiologists have looked for a duration-response relationship to see if the risks increased with longer use. Since no one was looking for this kind of effect in new users, and no one found this relationship (which may have been there all along), more reanalyses is needed to further clarify the issue, Westhoff says.
References
1. World Health Organization Collaborative Study on Cardiovascular Disease and Steroid Hormone Contracep-tion. Effect of different progestins in low oestrogen oral contraceptives on venous thromboembolic disease. Lancet 1995; 346:582-588.
2. World Health Organization Collaborative Study on Cardiovascular Disease and Steroid Hormone Contracep-tion. Venous thromboembolic disease and combined oral contraceptives: Results of international multicentre case- control study. Lancet 1995; 346:575-582.
3. Jick H, Jick SS, Gurewich V, et al. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet 1995; 346:1,589-1,593.
4. Spitzer WO, Lewis MA, Heinemann LAJ, et al. Third generation oral contraceptives and risk of venous thromboembolic disorders: An international case-control study. BMJ 1996; 312:83-87
5. Lewis MA, Spitzer WO, Heinemann LAJ, et al. Third generation oral contraceptives and risk of myocardial infarction: An international case-control study. BMJ 1996; 312:88-90.
6. Suissa S, Blais L, Spitzer WO, et al. First-time use of newer oral contraceptives and the risk of venous thromboembolism. Contraception 1997; 56:141-146.
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