China stopped producing and selling phenolphthalein tablets. What is the reason why this medicine was stopped?

The State Administration of Pharmaceutical Products recently issued the Announcement on Cancelling the Drug Registration Certificate of Phenolphthalein Tablets and Phenolphthalein Buccal Tablets. According to the announcement, according to Article 83 of the Drug Administration Law of People's Republic of China (PRC), the State Administration of Pharmaceutical Products organized the post-marketing evaluation of phenolphthalein tablets and phenolphthalein buccal tablets. It was found that there were serious adverse reactions in phenolphthalein tablets and phenolphthalein buccal tablets, and the risks in domestic use outweighed the benefits. It is decided to stop the production, sale and use of phenolphthalein tablets and phenolphthalein buccal tablets in China from now on, and cancel the drug registration certificate (drug approval number). Phenolphthalein tablets and phenolphthalein buccal tablets that have been marketed are recalled by the production enterprise, and the recalled products are destroyed under the supervision of the drug supervision and administration department where the enterprise is located.

According to the description of related drugs, phenolphthalein tablets are also often called? Directing movies? , mainly used to treat habitual and intractable constipation. Adverse reactions include dermatitis, drug eruption, itching, burning pain, enteritis and bleeding tendency.

Article 83 of the Drug Administration Law of People's Republic of China (PRC) stipulates that the holder of drug marketing license shall regularly evaluate the safety, effectiveness and quality controllability of listed drugs after marketing. When necessary, the drug supervision and administration department of the State Council may order the drug marketing license holder to conduct post-marketing evaluation or directly organize post-marketing evaluation. After review, the drug registration certificate shall be cancelled for drugs with uncertain curative effect, large adverse reactions or harmful to human health for other reasons. Drugs whose drug registration certificate has been cancelled shall not be produced, imported, sold or used. Drugs whose drug registration certificate has been cancelled or whose validity period has expired shall be destroyed under the supervision of the pharmaceutical supervisory and administrative department or other harmless treatment measures shall be taken according to law.

Phenolphthalein tablets and phenolphthalein buccal tablets have serious adverse reactions. Phenolphthalein tablets, also known as Daozhi tablets, are mainly used to treat intractable constipation. ?

But taking these drugs for a long time has great risks, which will stimulate people's gastrointestinal mucosa and trigger a series of serious drug reactions. Phenolphthalein tablets have a very strong catharsis ability, so after patients take phenolphthalein tablets, the food in the gastrointestinal tract will be excreted before it is fully digested and absorbed, which will lead to the loss of human nutrition over time, causing patients to have symptoms such as dull complexion, fatigue, palpitation and shortness of breath, which will lead to the decline of human immunity and increase the incidence of heart disease for a long time. ?

In addition, a large number of animal experiments prove that phenolphthalein may induce cancer. Long-term consumption of phenolphthalein tablets will cause irritation and damage to intestinal mucosa, which will not only lead to intestinal dependence, but also lead to the occurrence of patients with black bowel disease. Once black bowel disease occurs, it will even increase the chance of intestinal cancer. ?

Previously, many countries, including the United States, explicitly prohibited drugs containing phenolphthalein from entering the market. ?

The reason why it is widely used is mainly because it is cheap and effective. There are also some unscrupulous merchants who package phenolphthalein tablets into diet pills and sell them to people who need to lose weight in order to make huge profits. ?

The suspension of production and sales involves a number of listed companies according to the list of phenolphthalein tablets and phenolphthalein buccal tablets produced by the State Pharmaceutical Products Supervision and Administration. The suspension involves listed companies such as Li Sheng Pharmaceutical, Changshan Pharmaceutical, Special Pharmaceutical, Hanyu Pharmaceutical and Harbin Pharmaceutical?

A shares: Tianjin Li Sheng Pharmaceutical Co., Ltd. (Li Sheng Pharmaceutical), Hebei Changshan Biochemical Pharmaceutical Co., Ltd. (Changshan Pharmaceutical), Teyi Pharmaceutical Group Co., Ltd. (Teyi Pharmaceutical), Hunan Hansen Pharmaceutical Co., Ltd. (Hansen Pharmaceutical), Gansu Ji Cheng Biopharmaceutical Co., Ltd. (Hanyu Pharmaceutical Subsidiary), Inner Mongolia Lantai Pharmaceutical Co., Ltd. (China Tobacco Chemical Subsidiary), Harbin Pharmaceutical Group No.3 Refined Pharmaceutical Factory Co., Ltd. Guizhou Shengjitang Pharmaceutical Co., Ltd. (subsidiary of Shengjitang), Sinopharm Xinjiang Pharmaceutical Co., Ltd. (55% owned by Hyundai Pharmaceutical), Henan Shuanghe Huali Co., Ltd. (subsidiary of Shuanghe Pharmaceutical), Guilin Nanyao Co., Ltd. (Fosun Pharmaceutical Sun Company), Shanghai Xinyi Jiufu Pharmaceutical Co., Ltd. (Shanghai Pharmaceutical Sun Company) and Jilin Yatai Yongantang Pharmaceutical Co., Ltd. (Yatai Group Sun Company);

Hong Kong stocks: Yuanda Pharmaceutical (China) Co., Ltd. (Yuanda Pharmaceutical Subsidiary), Zheng Da Tianqing Pharmaceutical Group Co., Ltd. (China Bio-pharmaceutical Subsidiary) and Unocal Ou Yi Pharmaceutical Co., Ltd.;

New Third Board: Yuanhe Pharmaceutical Co., Ltd., Renhetang Pharmaceutical Co., Ltd. (parent company Yu Xiang Pharmaceutical New Third Board listed), Diaoyutai Pharmaceutical Group Jilin Tian Qiang Pharmaceutical Co., Ltd. (original New Third Board listed).