The hormonal acne drug Diane 35, approved in 135 countries around the world and frequently used as a contraceptive, has caused at least four deaths in France, the French medicines agency ANSM reported.
Women between the ages of 18 and 28 died from blood clots either in the lungs or in the brain. The National Agency for the Safety of Medicines and Medical Products, released on Sunday, indicates 125 other cases of blood clots and related complications in women taking Diane 35.
The number of tablets sold in France ranges from 4 to 5 million a year. The ANSM research shows that the pill was prescribed primarily by internists and gynecologists, and only 7 percent. – dermatologists.
Bayer’s Diane 35 was introduced to the French market in 1982 as a drug for treating adolescent acne. Due to the high level of progesterone, the drug quickly began to be recommended by doctors as a contraceptive, although the French authorities never authorized it.
Disturbing signals that the pill carried a risk of complications began to appear as early as 1982. The medical journal Proscrire then reported that the progesterone contained in Diana 35 increased the risk of blood clots by 6,68 times. Bayer has declined to conduct research on these risks.
In May 2011, ANSM experts became interested in the scale on which the pill was prescribed as a contraceptive, which resulted in the report published on Sunday.
Meanwhile, the minister of health and social affairs, Marisol Touraine, advised doctors not to prescribe third-generation and fourth-generation contraceptive pills, which are supposed to cause similar complications as Diane 3. The minister’s decision follows a lawsuit brought in mid-December by a young woman against Bayer, the manufacturer of the third-generation pill. . As a result of its use, the woman suffered cerebral palsy, which paralyzed her body. Thirty more lawsuits against pharmaceutical companies producing 4rd and 35th generation tablets were filed in early January. (PAP)
day/ night/