2011may 3 1 day, four contraceptives owned by Bayer in Germany are under investigation by FDA. The FDA posted a message on its drug safety communication website about the safety of compound oral contraceptives containing drospirenone owned by Bayer Pharmaceutical Company, saying that the research results are being evaluated because some studies show that "consumers use these four contraceptives owned by Bayer Company. 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.
Chinese mainland.
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.
Bayer responded.
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. When talking about the survey data of drug use risk, the head of the 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 unreasonable 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 national food and drug supervision situation. "
Bayer Pharmaceuticals responded to the FDA investigation on June 2, 20 1 1, saying that the incident originated from a scientific study published in the British Medical Journal, and the FDA only issued a safety warning routinely. Bayer Pharmaceuticals said that the aforementioned scientific research samples are small and the experimental methods are flawed. There are some problems in the evaluation system and the conclusion is debatable.
The FDA only asked Bayer Pharmaceuticals to re-evaluate the data of oral contraceptive products. If the risk of adverse reactions mentioned above does exist, the worst result is to modify the instructions and clearly indicate this risk in the instructions. But there is no risk of product recall or even delisting. The above Bayer medical people told reporters. The FDA website also shows that patients should not stop taking drugs before communicating with doctors, and the instructions of all Bayer compound oral contraceptives in the United States have not changed.
She also stressed that the US Food and Drug Administration in China did not communicate with Bayer Pharmaceuticals on this matter. The company will actively communicate with the FDA to update any new news about the products.
The statement issued by Bayer Pharmaceuticals on June 2, 20 1 1 also shows that up to now, compound oral contraceptives are one of the most systematic and widely used drugs in clinical research. Clinical research of more than 15 years and post-marketing clinical research of nearly 10 years show that no matter what kind of progestin is contained, all compound oral contraceptives rarely have such serious side effects as venous thrombosis. "These large-scale studies are recognized by many experts in the industry as the most complex and excellent experiments. These designs control key confounding factors and reduce the risk of deviation. "
Investigated by China Industrial and Commercial Department.
Foreign media reported that Bayer China was investigated by the industrial and commercial departments. Yesterday, Bayer Healthcare Co., Ltd. confirmed to the Yangcheng Evening News reporter that the industrial and commercial department of China did go to an office of the company at the end of August to investigate whether it was suspected of unfair competition. It said that it is fully cooperating with the work of the industrial and commercial departments.
Acquisition of Dianhong
201April 19, the German pharmaceutical giant Bayer announced that it had signed an equity transfer agreement with Yunnan Dianhong Pharmaceutical, and Bayer would acquire all the shares of Dianhong Pharmaceutical as a whole. According to former Dianhong executives, the acquisition amount may be as high as 3.6 billion yuan.