The State Food and Drug Administration announced that the drug was banned for children

On November 19, the State Food and Drug Administration issued two announcements to revise the drug specifications of cerebrosine and carnosine injection and compound osteopeptide injection respectively According to the requirements of the announcement, all manufacturers of cerebrosine and carnosine injection and compound osteopeptide injection shall, in accordance with the measures for the administration of drug registration and other relevant regulations, put forward the supplementary application for the revision of the instructions in accordance with the corresponding requirements for the revision of the instructions, and report to the provincial drug regulatory authorities for the record before January 8, 2020 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 Replace all drug instructions and labels that have been delivered within 6 months after the supplementary application is filed According to the requirements of the State Food and drug administration, the drug Manual of brain glycoside and carnosine injection shall be added with [warning words], as follows: This product contains monosialotetrahexose ganglioside Cases of acute inflammatory demyelinating polyneuropathy (also known as Guillain Barre syndrome) that may be related to the use of ganglioside products were found in the post marketing monitoring of drugs at home and abroad If the patient is unable to hold things, has weakness of limbs, and has flaccid paralysis during the period of medication (generally within 5-10 days after medication), he should be treated immediately This product is not allowed in patients with Guillain Barre syndrome As early as November 2016, the former State Food and Drug Administration issued a document to revise and add warning words to the drug Manual of sialyl tetrahexosylganglioside injection, while brain glycoside and carnosine injection, as a compound preparation, was not within the scope of the revised manual at that time According to the data, Guillain Barre syndrome (GBS) is an autoimmune peripheral neuropathy characterized by demyelination of peripheral nerve and nerve root and infiltration of small vessel inflammatory cells The classic GBS is called acute inflammatory demyelinating polyneuropathy (AIDP), and its clinical manifestation is acute symmetric flaccid limb paralysis According to the requirements of the State Food and drug administration, the compound osteopeptide injection should add [warning] on the basis of the original instructions: This product has serious allergic reaction case report, and it is forbidden to use for those allergic to this product The product should be used in the medical institutions with rescue conditions The user should have received the rescue training of anaphylactic shock If there is anaphylactic reaction or other serious adverse reactions after the application, the drug should be stopped immediately and the treatment should be carried out in time At the same time, on the basis of the original taboo, add the following content: Disabled for children It is forbidden for pregnant women and lactating women Severe hepatorenal insufficiency is forbidden Before that, when many drugs were modified, there was a special reference to children's prohibition or careful use It can be seen that all parties pay more and more attention to the drug safety of children It is believed that you have found that the two drugs mentioned in the revised instructions are the first batch of national key controlled rational drug use categories Wu Jianlong, director of the Pharmaceutical Department of Shenzhen No.2 People's Hospital, told sablan that it is a very responsible attitude for the relevant national management departments to revise the instructions for the two varieties in view of the collected information and adverse reaction monitoring data, indicating that the previous instructions for these drugs did not provide enough information for doctors, pharmacists and patients to refer to and assess the benefit risk before use He also reminded that when the public needs to use such drugs, they can consult doctors and pharmacists for benefits and risks before use, pay attention to prevent relevant risks, and seek medical treatment in time in case of suspected adverse reactions In addition to the introduction of the key monitoring catalogue, in this year's adjustment of the medical insurance catalogue, all the key monitoring drugs have been transferred out of the national medical insurance catalogue In the subsequent work of cleaning up the local medical insurance catalog, it was also reported that drugs in the key monitoring catalog were the first to be removed from the medical insurance catalog According to the data of mienei.com, the market sales of cGMP in 2018 is about 3.3 billion, with a market growth rate of - 10.66% From the chart below, we can see that the market growth rate of cGMP has been declining in recent years, with negative growth since 2017 (data source: minenet) And compound osteopeptide has a similar situation According to the data of minenet, the market sales of compound osteopeptide in 2018 is 820 million, with a market growth rate of - 13.64% The market also has a negative growth since 2017 (data source: minenet)