China Business Daily / China Business Network (reporter Jie Yuxing) "hypoglycemic miracle drug" metformin was exposed to contain carcinogens in recent days has attracted attention from the outside world. According to the official website of the U.S. Food and Drug Administration (hereinafter referred to as FDA), the content of n-nitrosodimethylamine (hereinafter referred to as ndma) in metformin sustained-release preparations exceeded the standard, and it is recommended that five manufacturers voluntarily recall their products. At present, apotex corp and amneal pharmaceuticals llc have issued recall information, and the relevant pharmaceutical companies in China have not been affected.
It is reported that the common dosage forms of metformin in the clinic mainly include ordinary dosage forms, intestinal solvent types and extended-release dosage forms, and the drugs involved in exceeding the standard are mainly extended-release dosage forms.
Lin Xiaofang, an expert in the consulting and management of the pharmaceutical industry, introduced to the China Business Daily reporter that metformin is currently a widely used hypoglycemic drug in the world, with better efficacy and low price, and is a first-line drug for type 2 diabetes, which is known as "hypoglycemic miracle drug" in the industry.
However, recently fda issued a document saying that in some metformin sustained-release preparations, the carcinogenic nitrosamine impurity content exceeded the standard, and recommended that some companies voluntarily recall. "Hypoglycemic miracle drugs" are not safe, what is the impact on relevant pharmaceutical companies?
It is understood that the metformin extended-release tablets of domestic pharmaceutical companies such as BAHEAL Pharmaceutical, CSPC Ouyi, and Haizheng Xuantai have previously received FDA approval. At present, Lei Jifeng, director of BAHEAL Pharmaceutical, said that BAHEAL Pharmaceutical's testing of APIs and preparations, third-party testing, FDA testing and other results show that the metformin controlled-release agent Nida produced by the company is safe, and patients with type 2 diabetes can completely use drugs with confidence.
The China Business Daily reporter called two other pharmaceutical companies to conduct interviews on issues related to the metformin impurity incident, but as of press time, the above companies have not replied. In addition, the reporter tried to contact the domestic manufacturers of metformin sustained-release preparations, including Renhe Pharmaceutical, Yuekang Pharmaceutical, etc., but the other party did not reply.
In addition, according to the "Economic Daily" report, multinational pharmaceutical companies Merck Pharmaceutical responded to this incident, in recent times, the United States, South Korea, Japan, Canada and other international markets have been recalled in different dosage forms including plain tablets and extended-release tablets, in view of the diversity and complexity of the causes of ndma, and has not yet formed a unified testing specifications and evaluation standards, Merck Pharmaceutical has set up a cross-functional team of experts to carry out research and testing work on ndma. At present, Merck Pharmaceutical has conducted multiple batches of tests on the RAW Materials and Tablets of Gehuazhi XR (Metformin Extended-Release Tablets) according to the requirements of the drug regulatory department, and the results show that the Gehuazhi XR (Metformin Extended-Release Tablets) produced by Merck meets the safety requirements.
Relevant professionals introduced to the China Business Daily reporter that ndma is a common nitrosamine substance. Such substances may be found in bacon, grilled meats, pickled pickles, and pickled aquatic products that people love to eat. At present, the temporarily acceptable intake of ndma is 96ng/day, but excessive intake will cause damage to the body and may even die, such as the poison in Huang Yangzhong, the victim of the Fudan University poisoning case that shocked the whole country, which is ndma.
On May 8 this year, the Drug Evaluation Center of the State Drug Administration issued the Technical Guidelines for the Research of Nitrosamine Impurities in Chemical Drugs (Trial Implementation) (hereinafter referred to as the Guiding Principles). The guidelines suggest that long-term exposure to mutagenic carcinogens such as ndma above acceptable levels may increase the risk of cancer, but people who take drugs containing drugs equal to or below acceptable levels of ndma daily for 70 years do not increase their risk of cancer.
The above guiding principles indicate that according to current knowledge, in the process of drug production, nitrosamine impurities are produced for a variety of reasons, such as different processes, degradation routes, etc. will produce such substances.
However, the FDA recommends that even in the event of a recall, patients should continue to use metformin until medical professionals find other alternative drugs, abruptly stopping the drug or putting their lives at risk.