Previously, the national drug authority issued a bulletin on the revision of the chlorazine note (2019 no. 64). According to the bulletin, nine amendments were made to the warning words, negative reactions, taboos, precautions, medication for pregnant and lactating women, medication for children, medicine for old age, drug interaction and overdose。
The bulletin shows that the warning lines add five elements to the problem of particle cell deficiency, epilepsy, physical hypotensive pressure, cardiac arrhythmia, adverse reaction of pervulsions and other cardiovascular and respiratory systems, myocarditis, myocardiosis and incomplete secondary valves, as well as to the increase in mortality among elderly persons with mental illness associated with dementia。
The note added, in addition to the five new elements of the alert, the neural retardant malignant syndrome (nms), delayed motor disorders, high blood sugar, metabolic changes such as high blood resin, increased body weight, drops, increased acidic particle cells, prolonged periods of qt, relapse of mental illness and cholineal retrenchment after sudden stoppage, cerebrovascular malaction, general care, etc. In this context, general attention is drawn to the fact that chlorazine has a clear risk of pelvic cell deficiency and epilepsy, as well as a high risk throughout the treatment process, and therefore it is prohibited to extend the treatment for patients whose treatment with chlorazine does not have a significant effect. In the case of patients who are more effective at chlorazin and still need to continue to take drugs, they should be regularly examined and evaluated. Care should be taken in cases where other drugs have caused particle cell deficiency。
The adverse effects add to the common adverse effects, adverse effects/incidents, other reactions observed in or following monitoring of the exposure to chlorazine clinical trials. Among these, adverse reactions/incidents detected in or after the monitoring of chlorazine in clinical trials include central nervous system, cardiovascular system, digestive system, urinary reproduction system, autonomous nervous system, skin, musculoskeletal system, respiratory system, blood/lymphatic system, metabolism and nutritional disorders, conesular symptoms, symptoms of muscle tension。
The following items have been added to the ban: severe heart, liver, kidney disease, low blood pressure, glaucoma patients; patients who are allergic to chlorazine or other groups of chlorazine; patients with bone marrow amplification disorders; epilepsy patients who are not under effective control; patients with palsy intestinal infarction; patients who have suffered from particle deficiency or severe particle cell reduction due to chlorazine; and patients with severe central nervous system inhibition or coma for various reasons, similar to typical antipsychiatry. It is prohibited to co-exist with other drugs that cause particle cell deficiency or bone marrow inhibition。
According to the bulletin, special attention is drawn to the amendment of the medication for pregnant and lactating women to the fact that there are not enough clinical studies for pregnant women. Pregnant women are banned. Breast-feeding women should stop breastfeeding while using chlorazin。
The item on children's medication has been revised to read that the safety and effectiveness of children using chlorazine is not clear. Children under 12 years of age are unfit for use。
The old-age medicine line was amended to read that a sufficient number of 65-year-old patients were not selected in the clinical study of chlorazine, and it was not clear whether the response of older patients was different from that of younger patients. Older patients, especially those with cardiovascular disorders, should be aware of the negative effects described above. The dose selection of elderly patients is important。
The bulletin requires all chlorazine producers to submit a supplementary request for amendments to the chlorazine statements, in accordance with the relevant provisions, such as the drug registration and management scheme, to the provincial drug regulatory authority by 12 october 2019. Revisions concerning drug labelling should be accompanied by amendments; the instructions and other aspects of the label should be consistent with the original approval. All medical instructions and labels that have been released are replaced within six months of the filing of the supplementary application。
The above-mentioned chlorazine tablet producers should conduct an in-depth study of the new mechanisms for the occurrence of adverse reactions, take effective measures to provide awareness-raising training on the use and safety of medicines, immediately notify drug operators and users in an appropriate manner of changes in content relating to the safety of the use of medicines, and guide physicians and pharmacists in the rational use of medicines. Clinicians and pharmacists should carefully read the revised version of the chlorazine tablets and, in selecting medicines, should conduct a full benefit/risk analysis based on the new revised version. Patients should strictly follow medical instructions, and instructions should be carefully read before using them。
