News from the Beijing News (Reporter Wang Kara) On March 22, the State Food and Drug Administration issued an announcement that according to the results of the adverse drug reaction assessment, in order to ensure the safety of public medication, the State Food and Drug Administration decided to reduce phlegm in children. The instructions [Adverse Reactions], [Contraindications] and [Precautions] of cough suppressant preparations have been revised uniformly, including over-the-counter and prescription drugs.
In the revision of over-the-counter drug inserts, adverse reactions should include: monitoring data show that the pediatric anti-phlegm and anti-cough preparations have vomiting, nausea, diarrhea, abdominal pain, rash, itching, sweating, Dizziness, headache, allergic reactions and other adverse reactions reported. Contraindications should include “prohibited for those who are allergic to this product and its ingredients”. Precautions should include “infants should take it under the guidance of a physician”, “patients with liver disease, kidney disease and diabetes should take it under the guidance of a physician”, “use with caution in people with allergies”, “use with caution in children with heart disease”, “in patients with spleen deficiency and easy diarrhea” There are a total of 13 items, including “Be Careful”.
Adverse reactions and taboo items of prescription drugs are the same as those of non-prescription drugs, but the “precautions” need to be added with four items, namely “this product contains Ephedrine hydrochloride“, “Use with caution in athletes”, “Use with caution in children with heart disease”, and “Use with caution in patients with spleen deficiency prone to diarrhea”.
According to the database of the State Food and Drug Administration, there are 69 approvals for Pediatric cough and phlegm preparations, including Pediatric Huatan Zhike Granules, Pediatric Huatan Zhike Syrup, Pediatric Huatan Zhike Granules, Involving Tongjitang (Guizhou Pharmaceutical) of Sinopharm Group, Shenwei Pharmaceutical, Fangsheng Pharmaceutical, Liangmianzhen Yikang Pharmaceutical, Taiji Group Sichuan Nanchong Pharmaceutical, Sunflower Pharmaceutical, Golden Throat Pharmaceutical, Yanan Bikang and other dozens of drugs Enterprise.
Proofreading Li Ming