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France reintroduces controversial acne drug
Since 1987, Diane-35, which has been approved in France, has not only been used for acne. Because of the hormones it contains, the drug also has a contraceptive effect and was taken by around 315,000 women as birth control pills, according to the French drug regulator ANSM. At the end of January 2013, the ANSM then ordered a prescription ban on the controversial drug. The background was that the preparation from the German pharmaceutical company Bayer was suspected of promoting thrombosis.
Four women died and 125 cases of blood clots Four women have died since 1987 as a result of thrombosis attributed to drug use by experts. Thromboses are blood clots that close the blood vessels and in the course of which blood congestion can lead to pulmonary embolism and strokes.
According to the ANSM, the investigations that followed the public debate about the benefits of the drug triggered 125 other cases of blood clots in the veins and arteries. While all of these had not been classified as fatal, they gave cause for concern and prompted the French authorities to act.
Bayer said at the time in a statement that the drug should only be prescribed for the treatment of acne and not as a contraceptive. In addition, the risk of thrombosis could be clearly seen on the package insert, a company spokesman said.
Bayer announced last Wednesday that the drug would come back to the market in consultation with the French health authority. The European Medicines Agency (EMA) had protected Diane-35 in May last year and rated the benefits of the drug as higher than the risk of dangerous thrombosis. With the new introduction however changes in the application are connected.
According to Ema, the drug should only be taken by patients who are affected by mild to severe acne and for whom other drugs do not work sufficiently. 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 at the debate a year ago that the prescription of the drug in Germany will only be made under severe restrictions. As a pure contraceptive, German doctors will no longer prescribe the preparation.
Individual factors can lead to thrombosis In principle, thrombosis can also arise if blood clotting in the human body no longer functions properly. If there are also individual factors, such as a genetic tendency to thrombosis or being overweight, the risk increases. However, in the worst case, restricted mobility or severe acute pneumonia can lead to the formation of thrombosis. Statistics from the German Society for Angiology show that every year in Germany alone, around 80,000 people develop thrombosis of the leg vein and up to 30,000 patients die in the course of this. However, such a severe course can only occur if no treatment takes place. (fr)