Arabinosine monophosphate is a synthetic adenine nucleoside antiviral drug. Its pharmacological effect is to bind to the viral DNA polymerase, reducing its activity and inhibiting DNA synthesis. In recent years, the number of reports of vidarabine monophosphate for injection in the national adverse drug reaction case report database has shown a rapid growth trend. There are more reports of serious adverse reactions, and the phenomenon of off-label drug use is more prominent. Children under 14 years old use injectable monophosphate. About 80% of reports of adverse reactions to vidarabine phosphate occur.
1. Overall situation of adverse reaction reports
From January 1, 2004 to December 31, 2015, Mitsubishi Japan, there were a total of 4118 case reports on vidarabine monophosphate for injection in the national adverse drug reaction case report database. Adverse reactions of vidarabine monophosphate for injection mainly involve the system: skin and appendage damage (47.14%), systemic damage (13.91%), gastrointestinal damage (13.76%). Adverse reaction reports mainly involve children under 14 years old. , accounting for 80.47%. Among them, there were 208 reports of serious adverse reactions, accounting for 5.05% of the total reports, involving 402 cases of adverse reactions, mainly involving systemic damage (33.33%), skin and appendage damage (24.38%), immune dysfunction and infection ( 9.95%), cardiovascular system damage (9.95%), etc. Adverse reactions mainly include high fever, anaphylactic shock, cyanosis, dyspnea, convulsions, leukopenia, etc.
2. Serious adverse reactions
Injectable vidarabine monophosphate can cause severe allergic reactions, such as anaphylactic shock. Among serious case reports, cases of severe allergic reactions such as anaphylactic shock, anaphylactoid reactions, dyspnea, and cyanosis accounted for 61.97% of the serious reports of this drug. Injectable vidarabine monophosphate may also cause mental disorders and nervous system damage (accounting for 11.54%). The main adverse reactions include tremor, numbness of limbs, convulsions, disturbance of consciousness, hallucinations, confusion, etc. Injectable vidarabine monophosphate may also cause damage to the blood system (6.25%), mainly manifested as bone marrow suppression, reduction of red blood cells, reduction of leukocytes, reduction of platelet count, etc.
Typical case: A 4-year-old child, male, was given intravenous infusion of 0.1g vidarabine monophosphate for herpesangina. About 10 minutes later, he developed convulsions, eyes staring upward, trismus, and cyanotic lips. , the hands and feet twitched, and the head tilted to one side, the drug was immediately stopped, metamizole was administered intranasally, and oxygen was administered. After 1 minute of twitching, the child’s symptoms were controlled, and 30 minutes later, the child’s condition was stable.
3. Off-label drug use
The approved indication of vidarabine monophosphate for injection in my country is “antioxidant 168″ for the treatment of stomatitis, dermatitis, encephalitis and cytomegalovirus infection caused by herpes virus infection.” However, under surveillance Data analysis found that there is serious off-label use of drugs, accounting for about 79.98% of the total reports, such as for bronchitis, pneumonia (25.50%), respiratory infections (23.65%), tonsillitis (4.52%), hand, foot and mouth disease (3.78%), etc. The pharmacological effect of vidarabine monophosphate is to bind to the DNA polymerase of viruses, reducing its activity and inhibiting DNA synthesis. It is only effective against DNA viruses and can cause bronchitis, pneumonia, hand and foot disease, etc. Common oral viruses such as rhinovirus, coronavirus, influenza virus, parainfluenza virus, respiratory syncytial virus, adenovirus, echovirus, coxsackie virus, etc. are all RNA viruses and should not be treated with vidarabine monophosphate.
Typical case: A 7-year-old child, female, took 0.1 g of vidarabine monophosphate for injection due to aversion to cold, fever, nasal congestion, and sneezing. Half an hour after taking the medication, the child developed dizziness, pale face, and difficulty breathing. The medication was stopped immediately, and the blood pressure was measured at 68/49 mmHg. Adrenaline 0.5 mg plus 5 ml of normal saline was given intravenously, and dexamethasone 5 mg plus 3 ml of normal saline was given intravenously. Promethazine 15 mg was injected intramuscularly, and 30 minutes later, the blood pressure rose to 90/60mm Hg, the heart rate was 100 beats/minute, and the clinical symptoms were gradually relieved.
