The Official Council of Official Colleges of Pharmacists has recalled through an official note that the Spanish Agency for Medicines and Health Products (Aemps) already reviewed the possible reactions associated with the active ingredient metanizol (Nolotil) in 2018. “on the occasion of the notification to the Spanish Pharmacovigilance System of cases of agranulocytosis, particularly in patients of British origin. He also consulted the Committee on Safety of Medicinal Products for Human Use of the European Medicines Agency and clinical experts on this matter”.
The prescription of this medication has achieved important relevance, after the Association of People Affected by Drugs (ADAF), presented a lawsuit against the Ministry of Health last November in the National Court. According to this entity, it has been reporting adverse reactions related to metamizole for years and claims to have identified 350 cases of agranulocytosis between 1996 and 2023. Of all of them, 170 were British.
In the information note issued by the Aemps, recommendations were made to use metamizole under the approved conditions of use, at the minimum dose and for a maximum of 7 days. If a longer treatment is required, perform periodic blood tests to early detect the reduction in leukocyte levels.
Monitor the appearance of symptoms of leukopenia and agranulocytosissuch as general malaise, chills, fever or mouth ulcers among others, and inform the patient to stop treatment if they appear.
Interview the patient in depth before prescribing to avoid prescribing it in patients with risk factors for agranulocytosis.
Finally, it was requested to pay special caution in elderly patients and avoid prescribing it in patients in whom it is not possible to carry out follow-up.to.
Metamizole is a drug with analgesic, antipyretic and antispasmodic activity, although its mechanism of action is not fully clarified. It is indicated for the treatment of moderate or intense acute pain, or fever that does not respond to other therapeutic alternatives.
The recommended dose is 575 mg up to a maximum of 6 times a day, each dose separated by 4-6 hours. It is usually well tolerated, with hypotension being the most common adverse reaction. However, it can also lead to allergic reactions, agranulocytosis and neutropenia. The mechanism of appearance of these adverse reactions seems to be immunological.
The risk of these adverse reactions is usually greater in elderly people, as well as in prolonged treatments longer than one week. A greater predisposition has also been observed in patients of British origin, although the cause is unknown, although it is possibly due to a genetic component of these populations.
2023-11-29 18:23:11
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