FDA Information

Dipyrone (metamizole) was banned in Sweden in 1974, and then in the United States in 1977. More than 30 countries including Japan, Australia, and most of the European Union, have followed suit. In these countries, metamizole is still occasionally used as a veterinary drug.

Nevertheless, some pharmaceutical companies, notably Hoechst and Merck, continue to develop metamizole and market them in some countries. In Germany it became a prescription drug, sold under the brands NovalginŽ, AnalginŽ, BerlosinŽ, MetalginŽ, Metamizol-PurenŽ, and NovaminsulfonŽ.

In the rest of the world (notably in Mexico, India, Brazil, Russia, and several Third World countries) metamizole is still freely available over-the-counter and remains one of the most popular analgesics. For example, this medication accounts for 80% of the OTC analgesic market in Russia, whereas ibuprofen accounts for 2.5%. Additionally, in Romania it is sold under the brands AlgocalminŽ, NovocalminŽ, AlgozoneŽ, and NevralginŽ, playing an important role in self-medication.

History:

Metamizole (dipyrone) was first synthesized by the German company Hoechst AG in 1920, and its mass production started in 1922. It remained freely available worldwide until the 1970s, when it was discovered that the drug carries a small risk of causing agranulocytosis - a very dangerous and potentially fatal condition. Recent studies estimate that the incidence rate of metamizole-induced agranulocytosis is between 0.2 and 2 cases per million person days of use, with approximately 7% of all cases fatal (provided that all patients have access to urgent medical care). In other words, one should expect 50 to 500 deaths annually due to metamizole in a country of 300 million, assuming that every citizen takes the drug once a month. This is not a very high rate, especially compared to other drugs - for example, the prescription drug clozapine is known to be at least 50 times more likely to trigger agranulocytosis. However, at the time the risk was assumed to be much greater and, as such, excessive for an over-the-counter analgesic, especially considering the existence of safer alternatives ( such as aspirin, paracetamol, and ibuprofen). 

Please visit the official site of the FDA for further information.

 

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