The European Medicines Agency is conducting a safety evaluation of Bayer Pharmaceuticals’ star contraceptive drug, Diane-35, CBN Daily reported.

Due to the fact that there have been more than 120 incidents since the launch of Diane-35, France has suspended the sale of this drug since January and has officially applied to EMA for an investigation of the drug.

Diane-35 went into the Dutch market in 1987 and there have been 3.7 million Dutch women who have taken the drug or other drugs that have the same active ingredients. Recently, Diane-35 has been accused of increasing the risk of vascular thrombosis, leading to the eventual death of four patients in the Netherlands.

The Netherlands’ Medicine Evaluation Board now prohibits doctors from prescribing Diane-35 and said they would wait for the result of EMA’s investigation before deciding whether to ban Diane-35.  

In China, Bayer’s long-acting contraceptives have almost monopolized the market of oral contraceptives.

“Long-acting contraceptives contain estrogen, which does increase the risk of blood clots if used in the long term. This has been confirmed many years ago. But the advantages of these drugs outweigh the disadvantages, and that’s why we don’t ban them,” said Sun Zhongshi, an expert from the Drug Evaluation Center of the State Food and Drug Administration.

Data from the administration shows that manufacturers producing drugs that have the same ingredients as Diane-35 include Zhejiang Xian Ju Pharmaceutical Co and Shanghai Xinyitianping Pharmaceutical Co. Therefore, there is a big uncertainty about whether the State Food and Drug Administration will follow up the tightening of security evaluation of such drugs if EMA rules to prohibit their sale, as those drug manufacturers would also be affected.

Bayer said Diane-35 is currently sold in 116 countries, and none of these countries has recalled the drug.