The European Medicines Agency (EMA) has published a direct healthcare professional communication (DHPC) containing important information for healthcare professionals who prescribe medicinal products containing metamizole.
Dear healthcare professional!
<Name of the registration certificate holder>, in agreement with the <European Medicines Agency> and the <National Competent Authority>, informs you of the following:
Brief overview
- Patients receiving treatment with medicinal products containing metamizole must be informed about:
- early symptoms indicating agranulocytosis, including fever, chills, sore throat and painful changes of the mucous membranes, especially in the mouth, nose and throat or in the genital or anal area;
- it is necessary to remain vigilant for these symptoms, as they can occur at any time during treatment, even shortly after treatment discontinuation;
- treatment must be stopped and medical help sought immediately if these symptoms appear.
- If metamizole (metamizole) is taken for fever, some symptoms of developing agranulocytosis may go unnoticed. In addition, symptoms may be masked in patients receiving antibiotic therapy.
- If agranulocytosis is suspected, a blood test (including a complete blood count) should be performed immediately and treatment should be stopped while awaiting the results. If the diagnosis is confirmed, treatment should not be resumed.
- <Routine monitoring of blood counts in patients receiving treatment with medicinal products containing metamizole is no longer recommended.>1
- Metamizole is contraindicated in patients with a history of metamizole-induced agranulocytosis (or agranulocytosis induced by other pyrazolones/pyrazolidines), impaired bone marrow function, or diseases of the hematopoietic system.
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1The text in brackets is subject to change at the national level if the instructions for medical use recommend routine monitoring of blood parameters in patients treated with medicinal products containing metamizole.
Background information on safety issues
Metamizole is a pyrazolone derivative belonging to the group of non-opioid analgesics, with pronounced analgesic, antipyretic and spasmolytic properties, indicated for the treatment of certain types of pain syndrome <and fever>, as stated in the instructions for medical use of each medicinal product containing metamizole. Metamizole is available as single-component <and combination> medicinal products.
Agranulocytosis, which can lead to serious or fatal infections, is a known adverse reaction of medicinal products containing metamizole. It involves a sudden and sharp decrease in the number of granulocytes (neutrophil level below 0,5x109/L).
<The instructions for medical use of various medicinal products containing metamizole state that agranulocytosis occurs with a frequency of "rare" (occurs in 1 out of 1000 people), "very rare" (occurs in 1 per 10 000 people), or "unknown" (cannot be estimated from the available data)>.
Following the Europe-wide review, the contraindications, warnings and precautions for the use of medicinal products containing metamizole, for both patients and healthcare professionals, will be revised in order to minimize the serious consequences of the known risk of agranulocytosis. This includes information on contraindications to the use of metamizole and promoting early detection and diagnosis of metamizole-induced agranulocytosis.
The review included an assessment of all available data, including scientific literature and post-registration reports, some of which contained information on fatal cases.
The review found no evidence supporting the effectiveness of routine monitoring of patients' blood counts for early detection of agranulocytosis caused by metamizole. Metamizole-induced agranulocytosis is not dose-dependent and can occur at any time during treatment, even in patients who previously used these medicinal products without adverse consequences. Therefore, this practice is no longer recommended.
The package inserts for medicinal products containing metamizole will be updated to reflect these important measures to minimize the consequences of the risk of agranulocytosis.
Call to report
It is important to report suspected adverse reactions after registration of a medicinal product. This allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are encouraged to report adverse reactions associated with the use of medicinal products containing metamizole to <the National Competent Authority>.
<In accordance with the requirements of the Procedure for Pharmacovigilance, approved by order of the Ministry of Health of Ukraine of December 27, 2006, No. 898, registered with the Ministry of Justice of Ukraine on January 29, 2007, under No. 73/13340, all suspected adverse reactions should be reported to the State Expert Center of the Ministry of Health of Ukraine at: https://aisf.dec.gov.ua/>
Contact person of the registration certificate holder
<Contact person details for obtaining additional information, including the address(es) of the relevant website(s), telephone numbers and postal address>
The full (original) text of the communication to healthcare professionals on the safety of medicinal products containing metamizole is available at the following links:
