State Food and Drug Administration
The State Food and Drug Administration plans to release the 70th “Adverse Drug Reaction Information Bulletin” to draw attention to the safety risks of vidarabine monophosphate for injection.
Single imported carbon black phosphate vidarabine is a synthetic adenine nucleoside anti-Tosoh matte powder virus drug. Its pharmacological effect is to combine with the viral DNA polymerase to reduce its activity. And inhibit DNA synthesis. It is clinically used to treat stomatitis, dermatitis, encephalitis and cytomegalovirus infection caused by herpes virus infection. Monitoring results show that the number of reports of adverse reactions to vidarabine monophosphate for injection has shown a rapid growth trend in recent years, with more reports of serious adverse reactions and the phenomenon of off-label drug use being more prominent.
Injectable vidarabine monophosphate can cause severe allergic reactions, such as anaphylactic shock, anaphylactoid reactions, dyspnea, etc. Vidarabine monophosphate may also cause mental disorders and neurological damage (such as tremors, Numbness of limbs, convulsions, disturbance of consciousness, etc.) and bone marrow suppression (such as decrease in red blood cells, decrease in leukocytes, decrease in platelet count, etc.). In the National Adverse Drug Reaction Case Report Database, reports of serious adverse reactions to vidarabine monophosphate for injection accounted for 5.05% of the total reports, and reports of adverse reactions in children under 14 years of age accounted for approximately 80%. The approved indication of vidarabine monophosphate for injection in my country is “for the treatment of stomatitis, dermatitis, encephalitis and cytomegalovirus infection caused by herpes virus infection”. Monitoring data shows that this variety has off-label use. , accounting for approximately 79.98% of the total number of reports, such as for bronchitis, pneumonia, respiratory infections, tonsillitis, etc.
Based on the data analysis of the National Adverse Drug Reaction Case Report Database, the State Food and Drug Administration recommends:
1. Injectable vidarabine monophosphate is prone to severe allergic reactions, such as anaphylactic shock, anaphylactoid reactions, dyspnea, etc., and may also cause mental disorders, nerve damage, and bone marrow suppression. Medical staff should ask patients in detail about their allergic history before using this product. People allergic to the ingredients contained in this product should not use it, and people with allergies should use it with caution. Observe the patient closely during the administration period. If any abnormality occurs, the medication should be discontinued immediately and treatment should be provided.
2. The phenomenon of off-label use of vidarabine monophosphate for injection is quite prominent in clinical use. It is recommended that medical personnel should strictly control the indications according to the drug instructions when using this product. There is currently no systematic research data on the safety and effectiveness of injectable vidarabine monophosphate in children. It is recommended that children weigh the pros and cons when using it.
3. It is recommended that manufacturers strengthen the safety monitoring of vidarabine monophosphate for injection, pay special attention to the safety of children’s medication, and at the same time strengthen publicity and training for medical personnel to ensure that product safety information is communicated to doctors in a timely manner and patients, to guide rational clinical use of drugs to reduce the occurrence of serious adverse drug reactions.
Tips:
1. Which disease is vidarabine monophosphate for injection used to treat?
Vidarabine monophosphate is the monophosphate compound of vidarabine. It is a synthetic adenine nucleoside antiviral drug. It is clinically used to treat stomatitis, dermatitis, and brain disease caused by herpes virus infection. inflammation and cytomegalovirus infection.
2. What are the main serious adverse reactions of vidarabine monophosphate for injection?
Injectable vidarabine monophosphate can cause severe allergic reactions, such as anaphylactic shock, anaphylactoid reactions, dyspnea, etc.; it may also cause mental disorders and nerve damage, with main manifestations including tremor, numbness of limbs, and convulsions. , disturbance of consciousness, hallucinations, confusion, etc.; bone marrow suppression may also occur, mainly manifested as decrease in red blood cells, leukopenia, and platelet count.
3. Which viral infections is vidarabine monophosphate for injection effective?
The pharmacological effect of vidarabine monophosphate is to bind to the DNA polymerase of viruses, reducing its activity and inhibiting DNA synthesis. Therefore, it is only effective against DNA virus infections and causes bronchitis, pneumonia, hand, foot and mouth, etc. Most of the viruses are RNA viruses and should not be treated with injectable vidarabine monophosphate. Off-label use of this drug will not only fail to bring therapeutic effects to patients, but may also bring safety risks to patients with adverse reactions.
4. What should you pay attention to when using vidarabine monophosphate for injection?
When medical staff use this product, they should strictly control the indications according to the drug instructions. They should ask the patient’s allergic history in detail before taking the drug. It is prohibited for those who are allergic to the ingredients contained in this product, and those with allergies should use it with caution. Observe the patient closely during the administration period. If any abnormality occurs, the medication should be stopped immediately and treatment should be carried out. There is currently no systematic research data on the safety and effectiveness of injectable vidarabine monophosphate in children. It is recommended that children weigh the pros and cons when using it.
