Pain and fever medications containing metamizole, such as Algocalmin, may be withdrawn from several European countries following reports of rare adverse reactions.
According to Ziara The European Medicines Agency (EMA) has launched an investigation into these drugs, including more than 15 products available in various countries, among them Algocalmin, Piafen, and Algozone.
Finnish Agency Raises Alarm
The primary concern is the potential for these medications to cause a rapid decrease in white blood cells, a condition known as agranulocytosis.
The Finnish Medicines Agency was the first to raise concerns about the safety of metamizole-containing medications. Although these products remain authorized for now, they are under close scrutiny due to the possibility of severe side effects.
The Romanian Medicines Agency has confirmed its participation in the European investigation, which is expected to conclude in September 2024. Depending on the findings, recommendations could include the complete withdrawal of metamizole from the market.
Historical Context and Regional Variations
Metamizole has been in use for over 100 years, with its potential to cause agranulocytosis known and documented in patient leaflets.
Health Minister Alexandru Rafila noted that the incidence of this immune-allergic condition is higher in Northern Europe compared to Southern Europe.
This discrepancy influences the risk-benefit analysis conducted by regulatory bodies in each member state. In 2010, similar concerns led to the restriction of metamizole sales to prescription-only status. '
The current review will determine whether further action is necessary to protect public health.
