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European Medicines Agency reviews risks of modern birth control pills
It has long been known that birth control pills cause an increased risk of thrombosis. However, the risk of life-threatening thrombosis differs greatly between the individual preparations. To enable consumers to assess the risk here, the European Medicines Agency (EMA) has now announced a review of contraceptive pills.
At the request of the French Medicines Agency, the EMA has decided to test third and fourth generation birth control pills "to determine if changes to the approval are necessary," the official announcement. Critics have long been calling for the sale of controversial drugs to be restricted. The European Medicines Agency is considering prescribing to women who cannot be helped with other "combined oral contraceptives". The current practice of using birth control pills against acne also seems questionable against the background of current criticism.
Increased risk of pulmonary embolism Millions of women in Germany use the contraceptive pill for contraception. It has long been known that they expose themselves to an increased risk of thrombosis. But the modern pills of the third and fourth generation seem to be significantly more dangerous here than conventional preparations. Apparently the risk of a blood clot with subsequent thrombosis, pulmonary embolism or a stroke is far higher with the newer birth control pills than with the pills of the first and second generation. According to the EMA, the risk of venous thromboembolism from taking the birth control pill is 20 to 40 cases per 100,000 users. The third and fourth generation contraceptives are associated with a risk that is around twice as high as the contraceptive pills of the first and second generation.
European Medicines Agency asked for review A renewed debate arose about the risks of modern birth control pills after a woman in France sued Bayer, a pharmaceutical company, for believing she had suffered a stroke from taking the Meliane pill in 2006 and has been severely disabled since then is. Now all third and fourth generation birth control pills should be put to the test. This affects products such as Yasmin, Yaz or Petibelle, but also the acne drug Diane 35, which is based on a similar principle of action. The French drug regulator has already announced it will withdraw Diane 35 from the market after four deaths from thrombosis have been linked to the drug in France. Following the now planned review of "the third and fourth generation of combined oral contraceptives", the EMA will decide "whether the currently available product information offers the best possible information for patients and doctors," the official announcement. This is the first time "that the member states have asked the agency for an EU-wide recommendation for these drugs under the new pharmacovigilance legislation (laws on drug monitoring)."
Second generation birth control pills preferred Possible risks from modern birth control pills are also taken into account in the recommendation of the Federal Institute for Drugs and Medical Devices (BfArM) regarding this contraceptive method. The BfArM recommends second-generation pills, especially for first-time users, so as not to unnecessarily increase the risk of thrombosis. The drug commission of the German medical profession comes to a comparable assessment, which generally advises women under 30 to avoid the pills of the third and fourth generation. Although modern pills with the active ingredient drospirenone are often preferred for cosmetic reasons or for the parallel treatment of acne, the associated risk of thrombosis should not be underestimated. However, according to the EMA, the combined oral contraceptives are "under strict surveillance by the national drug monitoring systems", so that there is no reason for women to stop taking their contraceptives abruptly or to change the preparation. If women have concerns, "they should discuss this with their doctor," recommends the EMA. Since switching to another preparation can initially also be associated with an increased risk of thrombosis, consultation with the doctor is generally recommended here.
Modern birth control pills with more side effects? The review of modern birth control pills ordered by the European Medicines Agency acts like water on the mills of critics who have long warned of the health risk of popular contraceptives. It seems remarkable to irritating that the third and fourth generation preparations are associated with more serious side effects than the older drugs. Usually, the reduction of existing side effects should always be a major factor in supposed improvements in medication. The main risk of birth control pills is the risk of thrombosis with consequences such as pulmonary embolism or a stroke. However, this risk has obviously increased significantly with the introduction of new drugs instead of decreasing. (fp)
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