The European Medicines Agency (EMA) recently said that it is now looking into drugs that contain metamizole, an opioid. Concerns that the safety measures in place to reduce the risk of agranulocytosis, a potentially fatal side effect, may not be sufficient, are the cause of this reaction.

According to the drug regulator, many EU countries use metamizole to treat moderate-to-severe pain and fever. Patients can use it to treat cancer-induced fevers and pain, as well as to alleviate the pain from surgery or accidents. A dangerous drop in white blood cells, called agranulocytosis, is known to occur as a side effect. This illness can lead to infections that are very bad and potentially fatal. 

According to the product information, agranulocytosis is a very rare or uncommon side effect of metamizole. Despite recent efforts to reduce the risk, reports of cases persist. The Finnish Medicines Agency requested this review because, despite stricter safety rules, Finland continued to report new cases. Once safety concerns surfaced, the sole Finnish company selling metamizole requested a halt.

The European Medicines Agency's safety committee, PRAC, will now look at all metamizole-containing drugs sold in the EU to see if they pose a risk of agranulocytosis. 

The committee will also examine the current use of the drugs and the effectiveness of the safety measures, and will then determine whether the drug's benefits outweigh its drawbacks and whether to alter, postpone, or revoke its marketing authorizations, according to the drug regulator.

EMA has asked the stakeholders, including the general public, to send relevant data for this review, including the public, patient groups, and medical professionals. 

The EU has used metamizole since the 1920s. India currently sells it under the brands Divi A, Bral, Analgin, and Alpagin. Usually, people administer the drug orally, as a suppository, or inject it to treat fever and moderate to severe pain.

All forms of metamizole, whether taken alone or in combination with other drugs, will be the subject of the study. Many European Union countries, including Austria, Belgium, Germany, Italy, and Spain, sell drugs containing methizole. However, Finland is withdrawing from the market for its only metamizole drug due to safety concerns.