Yasmin is the focus of Dutch safety alert
While the oral contraceptive (OC) Yasmin (Berlex Laboratories, Montville, NJ) has been the focus of interest in the United States for its potential in treating premenstrual syndrome, its safety has been questioned by Dutch medical officials, who are calling for more epidemiological data on the potential risk for venous thrombosis.
The Amsterdam-based Dutch College of General Practitioners issued a warning about the pill following the death of a 17-year-old female who was using the OC.1 The Dutch medicines evaluation board, which monitors adverse drug reactions in the country, recently received five reports of thromboembolism in connection with use of the drug.2
Yasmin has been licensed in Europe since November 2000. Schering AG of Berlin, Germany, Berlex Laboratories’ parent company, estimates that about 35,000 women in the Netherlands are using the pill, joined by 500,000 women in 17 European countries. Yasmin was approved by the Food and Drug Administration in 2001, and it entered the British market in 2002.
The risk of venous thromboembolism (VTE) associated with pill use has been of particular interest in Europe since 1995, when study findings suggested a higher risk among users of third-generation OCs compared to those on second-generation pills.3,4,5
The progestin in Yasmin is different from other pills; it is synthesized from 17 alpha spironolactone. According to the Dutch Medicines Evaluation Agency, some clinicians had been choosing the drug over second- and third-generation pills under the assumption that the risk of VTE would be less than other pills; however, such a conclusion cannot be reached from the available data, it stated.1
Yasmin’s manufacturers stand by the safety of the drug, says Kim Schillace, Berlex Laboratories spokeswoman. The company has monitored drug use since the OC was launched, and its data indicate there is no difference between Yasmin and any other oral contraceptive with respect to the risk of VTE, she states. Interim results from Schering’s post-marketing surveillance study of a million cycles show that, after one year, one venous thrombosis occurred among Yasmin users, compared with five among users of other oral contraceptives.1
All oral contraceptives and estrogen-containing products carry a labeled risk of venous thrombosis, Schillace notes. Health care providers and patients need to review the risks and benefits when women are considering use of these products, she states.
References
1. Sheldon T. Dutch GPs warned against new contraceptive pill. BMJ 2002; 324:869.
2. Van Grootheest K, Vrieling T. Thromboembolism associated with the new contraceptive Yasmin. BMJ 2003; 326:257.
3. World Health Organisation Collaborative Study on Cardiovascular Disease and Steroid Hormone Contraception. Venous thromboembolic disease and combined oral contraceptives: Results of international multicentre case-control study. Lancet 1995; 346:1,575-1,582.
4. 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.
5. 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; 312:83-88.
While the oral contraceptive (OC) Yasmin has been the focus of interest in the United States for its potential in treating premenstrual syndrome, its safety has been questioned by Dutch medical officials, who are calling for more epidemiological data on the potential risk for venous thrombosis.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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