Four contraceptives of Bayer Company in Germany are being investigated by FDA, because some studies show that "consumers may have a higher risk of thrombosis when using these four contraceptives of Bayer Company than other similar drugs". The report also pointed out that the EU asked Bayer to revise the drug instructions of these four related contraceptives and add the latest safety survey results. Among the four Bayer contraceptives exposed as "under investigation" this time, Yousiming is the only Bayer contraceptive imported from Chinese mainland, which belongs to prescription drugs. Officially listed in 2009, it was produced by Bayer Healthcare Co., Ltd. Guangzhou Branch and is still on sale.
According to public information, Yousiming (trade name) is a prescription drug in China, and drospirenone ethinylestradiol tablets are its product name. Regarding whether the recall will be considered, the person in charge of Yashiming products said that the incident has not been confirmed and it is impossible to reply. "It can only be said that there is no plan to recall at present." The product manager of Bayer Usmin said that as the fourth-generation oral contraceptive, the probability of thrombosis is very small, almost the same as similar drugs.
Talking about the survey data of drug risks, the head of China market of Bayer Schering Pharmaceutical Co., Ltd. Women's Health Products Group said, "We have noticed the two reports cited by the FDA, and we think that the conclusions are not well-founded, and the experimental methods also have obvious defects."
Bayer pointed out, "Bayer is actively cooperating with the EU investigation, and there is no plan to recall it at present. In the China market, we have not received the requirements of the US Food and Drug Administration. " The manager of Yasmin, who is in charge of one of the four products under investigation in Bayer (China) Medicine Department, confirmed to the National Business Daily: "At present, we have received the request from the European Union to amend the instructions, and the decision to amend them has been basically confirmed." The source pointed out that the EU's request to modify the contents of Bayer's instructions for oral contraceptives mainly means that "the possibility of adverse reactions such as venous thrombosis in the fourth-generation oral contraceptives is basically the same as that in the third-generation products, higher than that in the second-generation products".