France reintroduces controversial Diane-35

France reintroduces controversial acne medication

16/01/2014

Since 1987, the French authorized agent Diane-35 has not only been used against acne. Because of the hormones contained, the drug also has a preventing effect and was taken by some 315,000 women as birth control pills, as the French medicines supervision ANSM announced. At the end of January 2013, the ANSM ordered a prescription ban on the controversial drug. The background was that the preparation of the German pharmaceutical company Bayer was suspected of promoting thrombosis.

Four women died and 125 cases of blood clots
Four women died as a result of thrombosis since 1987, which experts have attributed to the use of the drug. Thrombosis is the term used to describe blood clots that occlude the blood vessels and that can lead to pulmonary embolisms and strokes as a result of blood congestion.

According to the ANSM, the investigations following the public debate on the use of the drug have revealed blood clots in veins and arteries in 125 other cases. Although all of them were considered to be non-fatal, they did raise concerns and prompted the French authorities to take action.

Bayer said in a statement that the drug should only be used to treat acne and not as a contraceptive. In addition, the risk of thrombosis from the package leaflet could be clearly seen, said a spokesman for the company.

Now Bayer announced last Wednesday that the drug will come back in consultation with the French health authority on the market. The European Medicines Agency (EMA) had already protected Diane-35 in May last year and rated the benefit of the drug higher than the risk of dangerous thrombosis. With the re-introduction, however, changes in the application are connected.

According to Ema, the drug should only be used by patients who are affected by mild to severe acne and other medications do not work well. In addition, those affected should specifically reduce the risk of thrombosis. Diane-35 is available in 135 countries worldwide. A spokesman for the Federal Institute for Drugs and Medical Devices (BfArM) in Bonn said a year ago in the debate that the prescription of the drug in Germany will only be under severe restrictions. As a pure contraceptive German doctors will no longer prescribe the drug.

Individual factors can lead to thrombosis
Basically, a thrombosis can also occur if the blood clotting in the human body is no longer working properly. In addition, individual factors, such as genetic thrombosis or overweight, increase the risk. However, even limited mobility or severe acute pneumonia can lead to the formation of thromboses in the worst case. The statistics of the German Society for Angiology shows that in Germany alone, around 80,000 people suffer from thrombosis of the leg vein every year and in the course of which up to 30,000 patients die. However, such a serious course can only occur if no treatment takes place. (Fr)