Regulatory
Published · Updated · 2 min read
DEC reports PRAC recommendation to add nausea and vomiting to diacerein adverse reactions
What it means for practice
Consider nausea and vomiting as possible adverse reactions to diacerein, with frequency unknown. The benefit–risk balance remains unchanged provided the product information is updated.
Summary
The State Expert Centre of the Ministry of Health of Ukraine (DEC) reported a recommendation from the Pharmacovigilance Risk Assessment Committee (PRAC) to update the product information for diacerein-containing medicines. Diacerein is used for the symptomatic treatment of hip or knee osteoarthritis.
Basis for the update
During its assessment of periodic safety update reports, PRAC reviewed data on nausea and vomiting from spontaneous reports and the literature. These included cases with a close temporal relationship and/or resolution after withdrawal or recurrence after re-exposure. PRAC considered a causal relationship between diacerein and these reactions to be at least a reasonable possibility.
Changes to the product information
- Nausea and vomiting should be added to the adverse reactions section under the system organ class “Gastrointestinal disorders”.
- Both reactions should be listed with frequency “not known”.
The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) agreed with PRAC’s conclusions. The benefit–risk balance remains unchanged provided the proposed amendments are implemented. The communication does not provide case counts or a numerical risk estimate.
Source
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Щодо внесення змін до інструкцій для медичного застосування лікарських засобів, що містять діацереїн (diacerein). Державний експертний центр МОЗ України.
Reviewed by: DrugCard editorial team ·
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