Health: ANSM alert on Antarène Codeine, potentially fatal

The National Medicines Safety Agency (ANSM) has just published a warning on Antarene Codeine. This drug which combines ibuprofen and codeine can be dangerous in the long term.

Serious side effects. Following the death of some patients, the National Medicines Safety Agency (ANSM) published a press release on February 13, warning of the potential dangers of Antarene Codeine.

According to the ANSM, “several cases of renal, gastrointestinal and metabolic toxicity have been reported” in countries where the drug “is available without a prescription”. Since 2017 in France, all medicines containing codeine are subject to compulsory medical prescription.

Combining ibuprofen and codeine, Antarene Codeine is prescribed for the treatment of moderate to severe pain.

According to the agency, “prolonged intake of this drug causes kidney damage (kidney failure) and a significant drop in the level of potassium in the blood (hypokalaemia) which can cause muscle weakness and disorders of the awareness. Perforations and haemorrhages in the stomach or intestines as well as severe anemia have also been observed”.

Thus, these particularly dangerous side effects can in particular lead to “death” during prolonged and abusive use.

The European Medicines Agency (EMA) has therefore requested that these side effects be added to the summary of product characteristics (SPC) and the package leaflet.

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