According to the State Food and Drug Administration website, a few days ago, the State Food and Drug Administration issued the No. 43 drug adverse reaction information bulletin to remind medical staff and patients concerned about the risk of severe allergic reactions caused by vitamin K1 injection.
Vitamin K1 injection is a 2009 version of the National Essential Drug List, which is mainly used for the treatment of various bleeding disorders caused by vitamin K deficiency. According to the data from the case report database of the National Center for Adverse Drug Reaction Monitoring, there are certain safety risks in vitamin K1 injection, and some unreasonable phenomena in clinical use, such as over-indication, overdose, and inappropriate route of administration, etc. Big risk of clinical use of vitamin K1 injection.
From January 1, 2004 to May 31, 2011, there were 893 cases of serious adverse reactions/events of vitamin K1 injection in the case report database of the National Center for Adverse Drug Reaction Monitoring, including 328 cases of anaphylactic shock (36.7%). Serious allergic reactions are the most prominent adverse reactions of vitamin K1. Serious adverse events/events are mainly systemic, respiratory, and cardiovascular system damage. Cases of serious adverse reactions were mainly administered intravenously (95.3%).
The State Food and Drug Administration recommends:
1. Medical personnel should ask the patient's history of allergies in detail before using the drug, and those who are allergic to the ingredients contained in vitamin K1 and injections should be banned, and allergic persons should be used with caution. During the administration period, the patient should be closely observed. Once allergic symptoms occur, the patient should be stopped and treated immediately.
2. Medical staff should strictly control the indications of vitamin K1 injection, weigh the advantages and disadvantages of the treatment of patients, and prudent use of drugs; strictly in accordance with the instructions and dosages prescribed by the drug instruction; choose a reasonable route of administration, and strictly control the speed of administration.
3. Manufacturers should revise the relevant contents of the description, increase the description of adverse reactions, especially serious allergic reactions; strengthen the promotion of clinical rational drug use, ensure that product safety information is communicated to patients and doctors in a timely manner; implement active monitoring, develop and implement effective risk Management plan to ensure drug safety.
Vitamin K1 injection is a 2009 version of the National Essential Drug List, which is mainly used for the treatment of various bleeding disorders caused by vitamin K deficiency. According to the data from the case report database of the National Center for Adverse Drug Reaction Monitoring, there are certain safety risks in vitamin K1 injection, and some unreasonable phenomena in clinical use, such as over-indication, overdose, and inappropriate route of administration, etc. Big risk of clinical use of vitamin K1 injection.
From January 1, 2004 to May 31, 2011, there were 893 cases of serious adverse reactions/events of vitamin K1 injection in the case report database of the National Center for Adverse Drug Reaction Monitoring, including 328 cases of anaphylactic shock (36.7%). Serious allergic reactions are the most prominent adverse reactions of vitamin K1. Serious adverse events/events are mainly systemic, respiratory, and cardiovascular system damage. Cases of serious adverse reactions were mainly administered intravenously (95.3%).
The State Food and Drug Administration recommends:
1. Medical personnel should ask the patient's history of allergies in detail before using the drug, and those who are allergic to the ingredients contained in vitamin K1 and injections should be banned, and allergic persons should be used with caution. During the administration period, the patient should be closely observed. Once allergic symptoms occur, the patient should be stopped and treated immediately.
2. Medical staff should strictly control the indications of vitamin K1 injection, weigh the advantages and disadvantages of the treatment of patients, and prudent use of drugs; strictly in accordance with the instructions and dosages prescribed by the drug instruction; choose a reasonable route of administration, and strictly control the speed of administration.
3. Manufacturers should revise the relevant contents of the description, increase the description of adverse reactions, especially serious allergic reactions; strengthen the promotion of clinical rational drug use, ensure that product safety information is communicated to patients and doctors in a timely manner; implement active monitoring, develop and implement effective risk Management plan to ensure drug safety.
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