Note the risk of birth control pills when prescribing

Prescription of birth control pills should take into account the risk of thrombosis
In light of the lawsuit filed by a young woman against the contraceptive pill maker, who blames her for her pulmonary embolism, the discussion about the risks of modern birth control pills has rekindled. "Venous thromboembolism is a well-known, rare side effect in the use of all hormonal contraceptives, the so-called combined hormonal contraceptives," reports the Federal Institute for Drugs and Medical Devices (BfArM). Most recently, in 2013, the Federal Institute, together with other European authorities and the European Medicines Agency (EMA), assessed the relationship between benefit and risk when taking such contraceptives.

The study of the BfArM at that time came to the conclusion that the benefits outweigh the risks in all combined oral contraceptives (COCs). However, the modern preparations often entail a significantly higher risk of venous thromboembolism. Therefore, the BfArM advises "preferential" prescribing of a combined oral contraceptive with a known lower risk of venous thromboembolism (levonorgestrel-containing COCs) among "first-time users and users below the age of 30 years." Users and prescribers should also be better informed about the risk of venous thromboembolism The BfArM demands.

The different risk of venous thromboembolism should be considered urgently when prescribing birth control pills. (Image: animaflora / fotolia.com)

Significantly increased risk of venous thromboembolism
According to the BfArM, the risk-benefit assessment from 2014 also took into account the risk of venous thromboembolism in order to clarify whether the use of funds had to be limited to specific patient groups. The risk of venous thromboembolism is significantly increased in the case of the contraceptive pills containing drospirenone. A total of 492 suspected cases of venous thromboembolism in women who have used the contraceptive pills containing drospirenone have so far been reported to the BfArM. Including 16 suspected cases of death. However, in many cases "based on the reported information, it is not possible to say with certainty whether the drug was actually the cause of the venous thromboembolism," reports the BfArM. Nevertheless, a considerably higher health risk is to be assumed for the preparations containing drospirenone.

Better informed about the risks
For this reason, the BfArM is in favor of using contraceptive pills with a known lower risk and, moreover, to better inform users about the risk of venous thromboembolism. Women should also be informed before prescribing how they recognize signs and symptoms of thrombosis and what personal risk factors exist (for example, smoking or being overweight), according to the BfArM. In 2014, with the participation of the BfArM, a red-hand letter was arranged and a checklist for doctors was developed to serve as a guide for the prescription. An internal user card has also been available since then, which is given to the patients by a new prescription by the doctor. The card contains important information on the risk of thromboembolism and explanations for the detection of thrombosis. The aim of the measures was to ensure that "doctors take greater account of the different risks when prescribing contraceptive pills and better explain to their patients during counseling that there are differences in the risks of contraceptive pills," the BfArM reports.

Do not use birth control pills for cosmetic reasons
For example, according to the Federal Institute, counseling by the doctor is of crucial importance if "young first-time users ask their doctor specifically for certain contraceptives without having first dealt with the risks." The doctors are here called upon to clarify the patients that contraceptive pills are not lifestyle products but medicines that can be risky. No regulation should be made for cosmetic reasons. Already in 2011, the BfArM claims to "make the risk of venous thromboembolism the selection criterion for oral contraceptives", after two studies on this topic, a higher risk of thrombosis in contraceptives with the female sex hormone drospirenone to pills with levonorgestrel was determined. (Fp)