Experts have issued a new warning for Metamizol, one of Germany’s most widely used painkillers. The European Medicines Agency (EMA) has decided to update the product information due to the risk of agranulocytosis, a severe side effect.
Metamizol: Benefits and risks
Metamizol, also known as Novaminsulfon, has been used in Europe since the 1920s to treat moderate to severe pain and fever. It’s available in various forms, including tablets, drops, suppositories, and injectable preparations. The drug is particularly effective in treating:
- Severe pain (post-operative, injury-related, dental, or headaches)
- Cramps and colic (kidney or gallbladder)
- Fever unresponsive to other antipyretics
- Cancer-related pain before opioid use becomes necessary
Despite its widespread use, Metamizol carries a significant risk that has prompted experts to reevaluate its safety profile.
Understanding agranulocytosis
Agranulocytosis is a serious condition characterized by a severe decrease in granulocytes, a type of white blood cell crucial for fighting infections. This dramatically weakens the immune system, increasing the risk of severe infections. Symptoms include:
- Fever
- Sore throat
- Mouth and gum ulcers
- General fatigue
The EMA emphasizes that this risk is dose-independent and can occur at any point during treatment, even in individuals who have previously taken the medication without issues.
New warnings and patient guidance
Following a reassessment initiated by Finland due to recurring cases, the EMA concluded that while Metamizol’s benefits still outweigh its risks, stronger warnings are necessary. The agency has ordered that product information be updated to reflect these concerns.
Patients taking Metamizol who experience symptoms of agranulocytosis should seek immediate medical attention. A blood test is required to confirm the diagnosis. If confirmed, Metamizol treatment is discontinued immediately, and patients often receive antibiotics to treat potential infections. Severe cases may require hospitalization for close monitoring and immune support.
The EMA advises against using Metamizol in patients with an increased risk of agranulocytosis. Patients should be aware that this medication is marketed under various brand names, including Novalgin, Algifen, and Buscopan Compositum, among others.
Sources of information:
- pharmazeutische-zeitung.de: “New warnings for metamizole”
- gesundheitsinformation.de: “Agranulocytosis”
