Patients with spleen and stomach deficiency and coldness are prohibited from taking Coptis chinensis supernatant preparations

On the 8th, the State Food and Drug Administration released the "Announcement on the Revision of the Instructions for Use of Coptis chinensis Supernatant Preparations" (hereinafter referred to as the "Announcement") on its official website, stating that based on the results of the adverse drug reaction assessment, in order to further ensure the safety of public drug use, the State Food and Drug Administration decided to uniformly revise the [Adverse Reactions], [Contraindications] and [Precautions] items in the instructions for use of Coptis chinensis Supernatant preparations (including pills, tablets, granules and capsules).

The revision requirements for the instructions for prescription drugs of Coptis chinensis supernatant preparations show that the [Adverse Reactions] item should include monitoring data showing that Coptis chinensis supernatant preparations have adverse reaction reports such as diarrhea, abdominal pain, nausea, vomiting, rash, itching, increased bowel movement, abdominal discomfort, fatigue, allergies or allergic reactions. The [Contraindications] item should add that it is contraindicated for people with spleen and stomach deficiency and contraindications for people who are allergic to this product and its ingredients. The [Precautions] item should include avoiding spicy food and using with caution for people with allergies.

The revision requirements for the instructions for over-the-counter drugs of Coptis chinensis supernatant preparations show that the [Adverse Reactions] item should include monitoring data showing that Coptis chinensis supernatant preparations have adverse reaction reports such as diarrhea, abdominal pain, nausea, vomiting, rash, itching, increased bowel movements, abdominal discomfort, fatigue, allergies or allergic-like reactions. The [Contraindications] item should add that it is contraindicated for people with spleen and stomach deficiency and those who are allergic to this product and its ingredients. The [Precautions] item should add that patients with hypertension, heart disease, diabetes, liver disease, kidney disease, etc. should take the product under the guidance of a physician; children, breastfeeding women, and the elderly and infirm should take the product under the guidance of a physician; take it strictly according to the usage and dosage, and this product should not be taken for a long time; if the symptoms do not improve after taking the medicine for 3 days, or other serious symptoms occur, go to the hospital for treatment; use with caution for people with allergies.

The announcement states that all the marketing authorization holders of the above-mentioned drugs should revise the instructions in accordance with the relevant provisions of the "Drug Registration Management Measures" and the requirements of the corresponding appendix, and report to the provincial drug supervision and administration department for filing before November 30, 2020. If the revision involves the drug label, it should be revised at the same time; the other contents of the instructions and labels should be consistent with the original approved content. Drugs produced from the date of filing shall not continue to use the original drug instructions. The drug marketing authorization holder shall replace the drug instructions and labels that have been shipped within 9 months after filing.

The announcement requires that drug marketing authorization holders should conduct in-depth research on the mechanisms of new adverse reactions, take effective measures to carry out publicity and training on drug use and safety issues, and guide physicians and patients to use drugs rationally.

The announcement reminds that clinical physicians should carefully read the revised contents of the above-mentioned drug instructions and conduct a full benefit/risk analysis based on the newly revised instructions when choosing medications. Patients should carefully read the drug instructions before taking medications and strictly follow the doctor's instructions when using prescription drugs.

The announcement emphasized that provincial-level drug supervision and administration departments should urge the drug marketing authorization holders of the above-mentioned drugs within their administrative regions to revise the corresponding instructions and replace labels and instructions as required, and severely investigate and punish illegal and irregular acts in accordance with the law.