Modern birth control pills on the test bench

European Medicines Agency checks the risks of modern birth control pills

04/02/2013

It has long been known that contraceptive pills cause an increased risk of thrombosis. However, the risk of a life-threatening thrombosis is extremely different in the individual preparations. In order to allow an assessment of the risk for consumers, the European Medicines Agency (EMA) has now announced a review of contraceptive pills.

Following a request from the French Medicines Monitoring Agency, the EMA has decided to review the third and fourth generation birth control pills, „to determine if changes to the authorization are necessary“, so the official message. Critics have long been demanding to restrict the sale of the controversial drugs. The European Medicines Agency is considering restricting the prescription to women who are not with others „combined oral contraceptives“ can be helped. The current practice of using contraceptive pills against acne also seems questionable against the background of current criticism.

Increased risk of pulmonary embolism
Millions of women in Germany use birth control pills for contraception. That they expose themselves to an increased risk of thrombosis has long been known. But the modern pills of the third and fourth generation seem to be much more dangerous than conventional drugs. Apparently, the risk of a blood clot with subsequent thrombosis, pulmonary embolism or a stroke in the newer birth control pills is far higher than for the first and second generation pills. According to the EMA, the risk of venous thromboembolism from taking birth control pills is 20 to 40 cases per 100,000 users. Third- and fourth-generation contraceptives, however, are about twice as risky as the birth control pills of the first and second generation.

European Medicines Agency asked for review
The renewed debate over the risks of modern birth control pills had come up after a woman in France complained against the pharmaceutical company Bayer because she had suffered a stroke in 2006 due to taking the Pill Meliane and has since been severely disabled. Now, all birth control pills of the third and fourth generation are to be put to the test. This affects, among others, preparations such as Yasmin, Yaz or Petibelle but also the acne drug Diane 35, which is based on a similar mode of action. The French Medicines Agency has already announced that it will withdraw Diane 35 after four deaths due to thrombosis associated with the drug in France. Following the now planned review „the third and fourth generation combined oral contraceptives“, will decide the EMA, „whether the currently available product information provides the best possible information for patients and physicians“, so the official message. This is the first time, „Member States have asked the Agency for an EU-wide recommendation for these drugs under the new pharmacovigilance legislation.“

Birth control pills of the second generation are preferred
Potential risks from modern contraceptive pills are also taken into account in the recommendation of the Federal Institute for Drugs and Medical Devices (BfArM) on this contraceptive method. The BfArM advises in first-time users in particular to second-generation pills so as not to unnecessarily increase the risk of thrombosis. A similar assessment is the drug commission of the German medical profession, which advises women in general under 30 years to a waiver of the pills of the third and fourth generation. Although for cosmetic reasons or for the parallel treatment of acne often the modern pills with the drug drospirenone preferred, but the associated risk of thrombosis should not be underestimated. However, the combined oral contraceptives are according to the EMA „under strict supervision by national drug monitoring systems“, so there is no reason for women to stop taking their contraceptives abruptly or to change the drug. Do women have concerns „they discuss this with their doctor“, recommends the EMA. Since the switch to another preparation may initially also be associated with an increased risk of thrombosis, consultation with the doctor is generally advised.

Modern birth control pills with more side effects?
The review of modern birth control pills, organized by the European Medicines Agency, works like water on critters' mills, which have long warned against the health risk of popular contraceptives. Remarkable to irritating it seems that the third and fourth generation drugs are associated with more serious side effects than the older drugs. Normally, reducing existing side effects should always be a major factor in supposed drug improvements. The main risk of birth control pills is the risk of thrombosis with consequences such as pulmonary embolism or stroke. However, this risk has apparently increased significantly with the introduction of new drugs instead of decreasing. (Fp)

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