Related Experiment Videos
Mianserin and agranulocytosis in New Zealand
1National Toxicology Group, Medical School, University of Otago, Dunedin, New Zealand.
Abstract:
The frequency with which agranulocytosis was associated with mianserin in New Zealand was calculated, by two methods, from spontaneous reports to the Intensive Medicines Monitoring Programme (IMMP)--one gave a frequency of 1 in 1354 (95% CI 1 in 3145 to 1 in 685) and the other gave a rate of 1 in 1743 (95% CI 1 in 2895 to 1 in 1116). There were 3 deaths. Age and dose seemed to be related to occurrence of agranulocytosis. The frequency of the complication seemed to be higher than that reported for other countries, perhaps because higher doses were prescribed in New Zealand but also perhaps because of a selection bias in surveys elsewhere. The occurrence of agranulocytosis with mianserin in New Zealand is higher than that of white-cell dyscrasias reported with use of chloramphenicol, phenylbutazone, and oxyphenbutazone, and although the case-fatality rate of agranulocytosis is lower with mianserin than with the other drugs, the overall mortality rate may be higher.
Insights
Agranulocytosis, a serious blood disorder, occurred more frequently with mianserin in New Zealand than in other countries. Higher doses and patient age may increase risk, with a potentially higher overall mortality rate.
Area of Science:
- Pharmacovigilance
- Clinical Pharmacology
- Hematology
Background:
- Mianserin is an antidepressant medication.
- Agranulocytosis is a severe adverse drug reaction characterized by a significant reduction in neutrophils.
- Spontaneous reporting systems are crucial for detecting rare but serious adverse drug events.
Purpose of the Study:
- To determine the frequency of agranulocytosis associated with mianserin use in New Zealand.
- To compare the incidence of mianserin-induced agranulocytosis with other countries and drugs.
- To identify potential risk factors for agranulocytosis.
Main Methods:
- Analysis of spontaneous adverse event reports submitted to the Intensive Medicines Monitoring Programme (IMMP).
- Calculation of agranulocytosis frequency using two distinct methods.
- Comparison of incidence rates with historical data and other medications.
Main Results:
- Two calculation methods yielded frequencies of 1 in 1354 and 1 in 1743 for mianserin-associated agranulocytosis.
- Three deaths were reported.
- Age and dosage appeared to be associated with the occurrence of agranulocytosis.
- The observed frequency in New Zealand seemed higher than in other countries, possibly due to higher prescribing doses or study biases.
- Mianserin-associated agranulocytosis occurred more frequently than white-cell dyscrasias with chloramphenicol, phenylbutazone, and oxyphenbutazone.
Conclusions:
- The incidence of agranulocytosis with mianserin in New Zealand is notable.
- Higher prescribed doses in New Zealand may contribute to the increased frequency.
- While the case-fatality rate for agranulocytosis is lower with mianserin, the overall mortality risk may be higher compared to other implicated drugs.