The new problems that arise after the drug is put into clinical use need to be adjusted in time. In particular, the specification needs to be revised. Recently, the State Drug Administration has revised the instructions for preparations of Chinese medicine of Tripterygium wilfordii.

Food and Drug Administration (Drugs and Drugs Supervision Bureaus) of provinces, autonomous regions, and municipalities directly under the Central Government:

According to the results of the assessment of adverse drug reactions, in order to control the risk of drug use, it was decided to amend the specifications of the preparations of TWP. The relevant matters are hereby notified as follows:

First, the preparation instructions for Chinese medicine preparations of Tripterygium wilfordii are revised in accordance with the revised requirements (see Annex). The other contents of the manual should be consistent with the original approval.

Second, please inform the pharmaceutical production enterprises in the administrative area to do the relevant work:

(1) Pharmaceutical manufacturers should revise their manuals as soon as possible and file them according to relevant regulations. Pharmaceuticals that have been manufactured since the date of approval of the supplementary application may not continue to use the original drug instructions. Pharmaceutical production companies should actively track the safety of clinical application of drugs, collect adverse reactions according to regulations and report in a timely manner.

(2) Pharmaceutical production enterprises shall promptly notify the relevant medical institutions, drug management companies and other entities of the contents of the revision, and promptly replace the exempted pharmaceutical instructions. The adverse consequences caused by the failure to replace the manual in a timely manner shall be the responsibility of the drug manufacturer.

(3) If the drug label involves related content, it shall be revised together.

Attachment: Amendment Requirements for Tripterygium Chinese Medicine Preparation Specification October 18, 2012 (public nature: voluntary disclosure)

Annex Amendments to the Instructions for Preparation of Tripterygium Chinese Medicine Preparations I. Increase the number of warnings, as follows:

Warning: The adverse reactions of Tripterygium sinensis preparations may involve multiple system damages. They should be used strictly under the instructions of the physician.

Second, the "adverse reactions" item should include:

1. Digestive system: dry mouth, nausea, vomiting, fatigue, loss of appetite, abdominal distension, diarrhea, jaundice, elevated transaminases; severe acute liver toxicity, gastric bleeding.

2. Blood system: leukocytes, platelets decreased; severe cases can appear agranulocytosis and pancytopenia.

3. Urinary system: Oliguria or urine, edema, renal dysfunction and other kidney damage; severe acute renal failure can occur.

4. Cardiovascular system: palpitations, chest tightness, arrhythmia, elevated or decreased blood pressure, abnormal electrocardiogram.

5. Reproductive, endocrine system: Women's menstrual disorders, less menstruation, or amenorrhea; men's sperm count decreases and vitality decreases.

6. Nervous system: dizziness, dizziness, lethargy, insomnia, neuritis, diplopia.

7. Others: rash, itching, hair loss, facial pigmentation.

Third, taboo items should include:

1. Children, pregnant women of childbearing age, pregnant women and nursing women are prohibited.

2. Cardiac, hepatic, and renal insufficiency are contraindicated; severe anemia, leukocytopenia, and platelet depletion are prohibited.

3. Patients with active gastric and duodenal ulcers are disabled.

4. Severe arrhythmia disabled.

Fourth, [Note] items should include:

1. This product is administered in strict accordance with the instructions in the instructions under the guidance of a doctor, and should not be used in excess.

2. During the medication should pay attention to regular follow-up and check the blood, urine, and electrocardiogram and liver and kidney function, if necessary, stop and give appropriate treatment.

3. Continuous medication should generally not exceed 3 months. If you continue to use medication, it should be decided by the doctor based on the patient's condition and treatment needs.