What's the matter with the revision of Wan Tong Jin Gu Pian's manual? As we all know, Wan Tong Jin Gu Pian is a drug for the treatment of lumbago and leg pain. What's the new content in the manual? Let's learn about it.
Beijing Youth Daily learned from the State Food and drug administration that according to the evaluation results of adverse drug reactions, in order to further protect the public drug safety, the State Food and Drug Administration decided to revise the "adverse reactions", "Taboos" and "precautions" in the instructions of Wantong Jingu tablet. It is required to add the contents such as "use according to the indications and dosage specified in the drug manual, not suitable for long-term use", "no evidence on the safety and effectiveness of children's use of the product" and "forbidden for infants and young children".
The "adverse reactions" item has increased the monitoring data after marketing, which shows the visible adverse reactions of the product, including the digestive system: nausea, vomiting, flatulence, heartburn, abdominal pain, diarrhea, constipation, etc.; the neuropsychiatric system: dizziness, headache, lethargy, numbness of mouth and tongue, tremor, etc.; the skin reaction: rash, pruritus, skin flushing, etc.; the cardiovascular system: palpitation, blood pressure rise, heart General reactions: chest distress, fatigue, edema, allergic reactions, etc., with fever and shivering case reports; others: with dyspnea and hematuria case reports.
In the revised manual, two kinds of people are forbidden to use Wantong Jingu tablets: those allergic to this product and its ingredients, and infants. Relevant contents have also been added in "precautions". For example, this product contains Chuanwu, Caohu and strychnine. In case of adverse reactions, the drug should be stopped and treated in time; it should be used according to the indications and dosage specified in the drug manual, not suitable for long-term use; it should be used with caution for lactating women and those with liver and kidney dysfunction. The patients with weak spleen and stomach should be cautious to use it; there is no evidence for the safety and effectiveness of this product in children.
The State Food and Drug Administration pointed out that the manufacturers of Wantong Jingu tablets should, in accordance with the measures for the administration of drug registration and other relevant regulations, put forward the supplementary application for the revision of Wantong Jingu tablets' instructions (see the annex), and report to the provincial drug regulatory authorities for the record before October 31, 2018. If the revised contents involve drug labels, they shall be revised together; the instructions and other contents of the labels shall be consistent with the original approved contents. Within 6 months after the supplementary application is filed, the ex factory drug instructions and labels shall be replaced. Wantong Jingu tablet production enterprises shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job in the publicity and training of Wantong Jingu tablet use and safety issues, and guide doctors to use drugs reasonably.