China stopped the production and sale of phenolphthalein tablets, which have long been abandoned abroad due to carcinogenesis

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On January 14, the State Drug Administration’s official website issued the “Announcement on Canceling the Registration Certificate of Phenolphthalein Tablets and Phenolphthalein Lozenges Drugs (No. 6 of 2021)” stating that it has decided to stop the use of phenolphthalein tablets and phenolphthalein lozenges in my country from now on. Production, sales and use, cancellation of drug registration certificate (drug approval number).

It is understood that phenolphthalein tablets are laxatives and laxatives, mainly used to treat habitual intractable constipation. The National Medical Products Administration organized a post-market evaluation of phenolphthalein tablets and phenolphthalein lozenges. The evaluation concluded that phenolphthalein tablets and phenolphthalein lozenges have serious adverse reactions, and the risks of use in my country outweigh the benefits.

The State Drug Administration requires that phenolphthalein tablets and phenolphthalein lozenges that have been on the market be recalled by the manufacturer, and the recalled products should be supervised and destroyed by the drug regulatory authority where the company is located.

According to the list of manufacturers of phenolphthalein tablets and phenolphthalein lozenges issued by the State Food and Drug Administration, the suspension involves listed companies such as Lisheng Pharmaceutical, Changshan Pharmaceutical, Teyi Pharmaceutical, Hanyu Pharmaceutical, and Harbin Pharmaceutical.

Phenolphthalein tablets, phenolphthalein lozenges, and fruit guide tablets (phenolphthalein tablets) are irritant laxatives. Due to its remarkable curative effect and low price and easy availability (1~4 yuan/100mg*100 tablets), it is still a common medicine for treating constipation in hospitals, especially in primary hospitals. Due to insufficient awareness of the severity of its adverse reactions, it is not only used by some "Ms. Aimei" to lose weight, but also used by some clinical patients to treat constipation and take it for a long time.

1. Due to carcinogenic effects, it has been withdrawn from the market in the United States

Phenolphthalein tablets or lozenges are commonly used clinically to treat habitual intractable constipation, and are also used for colon and rectal endoscopy or bowel cleansing before enema.

After phenolphthalein is taken orally or taken, it forms soluble sodium salt under the action of alkaline intestinal juice, thereby stimulating intestinal cells, enteric neurons and smooth muscle , increasing intestinal peristalsis, and at the same time inhibiting the absorption of water in the intestine, so that water and electrolytes The colon accumulates and produces a laxative effect.

Long-term use of phenolphthalein tablets or lozenges can cause gastric mucosal inflammation and even erosion and bleeding. Even in normal use, it will cause a certain degree of damage to the intestinal mucosa, and long-term use can cause irreversible enteric nerve damage.

Phenolphthalein has been found in animal experiments to induce tumors in rats or mice. Due to concerns about its safety in long-term use, products containing phenolphthalein have been withdrawn from the market in many countries.

2. Oral phenolphthalein tablets can cause severe hypokalemia

High-dose or prolonged use of phenolphthalein tablets may cause hypokalemia. If the patient's appetite decreases, the variety is monotonous, or strenuous exercise, even taking phenolphthalein tablets for a short time may cause hypokalemia.

The patient was male, 19 years old, active military. Constipation was diagnosed due to unresolved stool and lower abdominal pain on the 4th. Give 20ml of Kaisailu for external use, phenolphthalein buccal tablets orally, one tablet each time, once a day . On the first day after the medication, the patient relieved his stool and the abdominal pain relieved; on the second day, the patient continued to take the medication, and the limbs were weak and unable to walk.

The patient is generally healthy and denied having a history of family genetic diseases and allergies. Physical examination: body temperature 36.9℃, pulse rate 102 beats/min, blood pressure 110/82mmHg. The muscle strength of the limbs is significantly reduced, the tension is decreased, and the double Achilles tendon reflexes are significantly reduced. Emergency ECG examination showed low T wave and abnormal U wave. The clinical diagnosis is hypokalemia caused by drugs.

Special reminder: Phenolphthalein can cause allergic reactions, often rashes or pimples. It can also cause toxic epidermal necrolysis , manifested as diffuse, pleomorphic erythema, tenderness, accompanied by blisters of different sizes, the eyes, mouth, respiratory tract, digestive tract, digestive tract mucosa are simultaneously affected, and there are erosions and ulcers. And blindness.

3. Do not take phenolphthalein tablets for more than three days

About 15% of phenolphthalein tablets are absorbed after oral administration, and some of the absorbed drugs are excreted into the intestinal cavity through bile, and are reabsorbed in the intestine to form intestinal-hepatic circulation, prolonging the action time, and it takes 3 to 4 for one administration to eliminate day.

Continuous oral phenolphthalein tablets can accumulate in the body. Overdose or long-term use can induce arrhythmia, increase blood sugar, cause electrolyte disturbance, muscle spasm, fatigue, and even dependence on drugs. Therefore, take phenolphthalein tablets continuously, do not exceed 3 days.

Young women can't take phenolphthalein tablets casually to lose weight. Long-term use may also cause endocrine dysfunction, even affect fertility, and lead to infertility.

Tips:

Phenolphthalein tablets are forbidden for people with hypertension, congestive heart failure and weight loss;

Phenolphthalein can turn urine color into magenta or orange red;

The usual dose is 50~200mg, once a day. Soft stools are discharged 4 to 8 hours after oral administration and should be taken before going to bed.

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Origin blog.csdn.net/Bio12345/article/details/112606366