Beijing Daily Client | Reporter Yuan Lu
The website of the National Medical Products Administration issued an announcement on November 1 stating that according to the results of the adverse drug reaction evaluation, in order to further ensure the safety of public drug use, the National Medical Products Administration decided to uniformly revise the warnings and adverse reactions, contraindications and precautions in the instructions for injection, astragalus polysaccharide, sodium chlorinate injection and isatis root injection .
The State Food and Drug Administration stated that all marketing authorization holders of the above-mentioned drugs should revise the instructions in accordance with the relevant regulations such as " Drug Registration Management Measures " and other relevant regulations, and submit them to the provincial drug supervision and administration department for filing before January 27, 2023. If the revisions involve drug labels, they shall be revised together; the instructions and other contents of the label shall be consistent with the original approved content. Drugs produced from the date of registration shall not continue to be used in the original drug instructions. The drug marketing authorization holder shall replace the drug instructions and labels that have been shipped out of the factory within 9 months after filing.
At the same time, drug marketing authorization holders should conduct in-depth research on the mechanism of new adverse reactions, take effective measures to promote and train drug use and safety issues, and guide doctors, pharmacists and patients to use drugs reasonably. Clinicians and pharmacists should carefully read the revisions of the above drug instructions. When choosing medication, they should conduct sufficient benefits/risk analysis based on the newly revised instructions.
The State Food and Drug Administration reminds that patients should carefully read the drug instructions before taking the medicine. If they use prescription drugs, they should strictly follow the doctor's advice. Provincial drug supervision and administration departments shall promptly urge the drug marketing authorization holders of the above-mentioned drugs in the administrative area to revise and label and replace the instructions as required, and severely investigate and punish illegal and irregular acts in accordance with the law.
reporter checked the revision requirements of the instructions for isatis root injection. It was found that the warnings that should be added to isatis root injection include: adverse reactions include allergic shock, which should be used in medical institutions with rescue conditions. Users should receive allergic shock rescue training. If allergic reactions or other serious adverse reactions occur after taking the medicine, they must stop the medicine immediately and treat them in a timely manner.
Adverse reactions to isatis root injection should include: allergic reactions or allergic reactions, such as flushing, chills, fever, rash, itching, dyspnea , shortness of breath, palpitations , allergic shock, etc. The skin and its accessories, such as rash, itching, urticaria, erythema, sweating, etc. Systemic reactions, such as chest discomfort, chills, fever, pain, fatigue, , etc. Respiratory system, such as dyspnea, shortness of breath, etc.; gastrointestinal system: nausea, vomiting, diarrhea, etc. Others, such as dizziness, palpitations, increased or decreased blood pressure, eyelid edema, etc.
At the same time, it should be used with caution for special groups such as the elderly and patients who use isatis root injection for the first time, and clinical drug monitoring should be strengthened. Combination and combinations are strictly prohibited and medications are used with caution.
