State Food and Drug Administration: Niuhuang Jiedu tablet is forbidden for infants

Recently, the State Drug Administration issued a notice, according to the evaluation results of adverse drug reactions, in order to further ensure the safety of drug use by the public, the State Drug Administration decided to add warning words to the bone grafting tablets and bezoar antidote preparations (tablets, pills, capsules, soft capsules) of the Department of injury, and to add instructions to them and the heart stabilizing preparations (granules, capsules, tablets) [no Good response, taboo and precautions shall be revised According to the evaluation results of adverse drug reactions, in order to further ensure the safety of drug use by the public, the State Drug Administration decided to add warning words to Jiegu Tablet and Niuhuang antidote preparation (tablet, pill, capsule and soft capsule) of the Department of injury, and to add [adverse reactions], [contraindications] and [precautions] to the instructions of its and Wenxin preparation (granules, capsules and tablets), etc Item The relevant matters are hereby announced as follows: 1 All the above-mentioned pharmaceutical manufacturers shall, in accordance with the measures for the administration of drug registration and other relevant provisions, put forward the supplementary application for the revision of the instructions in accordance with the revision requirements of the corresponding instructions (see Annex 1-3), and report to the provincial drug regulatory authorities for the record before May 15, 2019 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 The above-mentioned drug manufacturing 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 relevant drug use and safety issues, and guide doctors to use drugs reasonably 2、 Clinicians should carefully read the revised contents of the above drug instructions, and make full benefit / risk analysis according to the newly revised instructions when selecting drugs 3、 The above-mentioned drugs are prescription drugs, and patients should strictly follow the doctor's instructions, and carefully read the above-mentioned drug instructions before use 4、 Each provincial drug regulatory department shall urge the above-mentioned drug manufacturing enterprises in the administrative region to do a good job in the revision of the corresponding instructions and the replacement of labels and instructions according to the requirements; organize strict investigation and punishment of the illegal behaviors according to law It is hereby announced Appendix: 1 Requirements for revision of the instructions of the bone grafting tablet of the Department of injury; 2 Requirements for revision of the instructions of the heart stabilizing preparation; 3 Requirements for revision of the instructions of the Niuhuang antidote preparation; 1 Requirements for revision of the instructions of the bone grafting tablet of the Department of injury; 1 The warning words should include: 1 Athletes should use it with caution 2 This product contains strychnine powder and cinnabar It can't be taken in over dosage or for a long time 2、 [adverse reactions] items should include: the monitoring data of adverse reactions after marketing and the literature reports show that the following adverse reactions can be seen in this product: digestive system: nausea, vomiting, anorexia, abdominal pain, diarrhea, liver biochemical index abnormality, etc Skin and its accessories: rash, pruritus, erythema, maculopapular rash, urticaria, etc Systemic damage: anaphylaxis, fever, asthenia, shivering and individual anaphylactic shock Mental and nervous system: dizziness, headache, convulsion, insomnia, etc.; respiratory system: chest tightness, suffocation, etc.; others: palpitation, elevated blood pressure, flushing, hematuria, menorrhagia, vaginal bleeding, purpura, arthralgia, tinnitus, etc 3、 [contraindications] should include: 1 Forbidden for pregnant women and lactating women 2 It is forbidden for children under 10 years old 3 It is forbidden in patients with liver and kidney dysfunction 4 It is forbidden to use this product or its ingredients if they are allergic 4、 [precautions] items should include: 1 Those with weak spleen and stomach and loose stools should be used with caution 2 This product contains strychnine powder and cinnabar It can't be taken in over dosage or for a long time 3 Athletes should be careful 4 Patients with fracture should be treated with medicine after reduction and fixation first Please differentiate syndrome and do not take it for a long time 5 In case of adverse reactions after medication, stop the medication in time and go to the hospital for treatment 5、 [children's medication] should include: there is no safety research data for children's medication Not for children under 10 years old 6、 [drug interaction] should include: This product should not be taken together with other drugs containing strychnine, cinnabar and other ingredients Annex 2 requirements for revision of heart stabilizing preparation instructions 1 [adverse reactions] should be added: the monitoring data of adverse reactions after marketing shows that the following adverse reactions can be seen in this product: nausea, vomiting, abdominal discomfort, abdominal distention, abdominal pain, diarrhea, dizziness, headache, rash, pruritus, chest distress, etc 2、 [contraindications] items should be added: it is forbidden to use this product and those who are allergic to its ingredients 3、 [precautions] items should be added: 1 No tobacco, alcohol or strong tea 2 The critical patients should adopt comprehensive treatment 3 This product contains dangshen, which should not be used with Veratrum Annex 3 requirements for revision of instructions of Niuhuang antidote preparation 1 Warning words shall include: This product contains realgar and cannot be taken in excess of dosage or for a long time 2、 [adverse reactions] items should include: monitoring data of adverse reactions after marketing and literature reports show that the following adverse reactions can be seen in this product: digestive system: diarrhea, abdominal pain, nausea, vomiting, dry mouth, stomach discomfort, etc.; case report of abnormal biochemical indicators of liver and gastrointestinal bleeding Skin and its accessories: rash, pruritus, facial edema, etc case reports of severe drug eruption (such as Stevens Johnson syndrome, bullous epidermal necrolysis drug eruption) Excessive or long-term use may lead to skin roughness, thickening, pigmentation and other arsenic poisoning Mental nervous system: dizziness, headache, drowsiness, insomnia, etc Immune system: anaphylactic reaction, anaphylactic shock, etc Cardiovascular system: palpitation, etc Respiratory system: dyspnea, chest tightness, etc Urinary system: case report of hematuria and acute renal injury In addition, cases of arsenic poisoning caused by long-term use have been reported 3、 [contraindications] should include: 1 Forbidden for pregnant women and lactating women 2 Forbidden for infants 3 It is forbidden to use this product or its ingredients if they are allergic 4、 [precautions] items should include: 1 Those with weak spleen and stomach and loose stools should be used with caution 2 This product contains realgar and should not be taken in excess of dosage or for a long time Arsenic poisoning has been reported for more than half a year 3 This product should not be taken together with other drugs containing realgar 4 Use with caution in patients with severe liver damage; use with caution in patients with acute and chronic kidney disease 5 There is no safety data for children No for infants 6 In case of adverse reactions, stop the drug in time and go to the hospital for treatment.