Pain and fever pills containing metamizole have come under the scrutiny of the European Medicines Agency after they allegedly caused rare side effects in some European countries.
Medicines containing metamizole could be withdrawn from the market – Photo Archive
Medicines for fever or pain containing metamizole may be withdrawn from several European countries. Among them is Algocalmin, also called noraminophenazone, with the trade name Algocalmin, used in the form of metamizole sodium. All these medicines are under investigation by the European Medicines Agency.
Specifically, several products containing metamizole, present in more than 15 pharmaceutical products sold in Romania as well, including algocalmin, piafen and algozone, are being reevaluated, according to TVR Info.
The reason? The possibility of a rare side effect, which can lead to a rapid decrease in white blood cells. The Finnish Medicines Agency has sounded the alarm in this regard.
These drugs remain licensed for now and are used to treat fever and moderate to severe pain. Careful monitoring of patients is essential to detect and manage any potential adverse effects.
The Minister of Health calls for calm
The Romanian Medicines Agency has announced that it will take part in the European investigation, which will end in September. Following this investigation, recommendations will be made which, depending on the results, may even lead to the withdrawal of metamizole from the market. Until the assessment is completed, the Minister of Health urges to remain calm.
“Metamizole is a product that has been used for more than 100 years, algocalmin. The agranulocytosis that it produces in certain cases, very rarely – between one in 10 thousand and one in 100 thousand cases – was known. It is not an unknown matter. It appears in the prospectus.“, Alexandru Rafila, the Minister of Health, said
There are concerns that this drug could be associated with the onset of agranulocytosis, a serious condition in which the number of white blood cells drops sharply, putting patients at risk of severe infections and fatal complications.
Romanian doctors and authorities have recognized a few severe cases of agranulocytosis related to metamizole, although it is a rare adverse effect. Despite this risk, metamizole remains an effective treatment for fever resistant to other antipyretics, they said.
“In the northern European states, the incidence of this immuno-allergic condition is much higher than in the southern states. The number of reactions at the level of each Member State is taken into account and it is decided whether or not the risk is considered to be greater than the benefit“, said Anca Crupariu, spokesperson, College of Pharmacists in Romania, according to the quoted source.
In the past, metamizole was re-evaluated in 2010 due to the same problem, after which it was restricted to prescription, which must be retained in the pharmacy.
Patients should be aware of the potential danger of metamizole and seek immediate medical attention if they experience fever immediately after administration to avoid the risks associated with agranulocytosis.
