The ANSM warns of the serious adverse effects in the event of prolonged intake of Antarène Codeine, a painkiller which combines ibuprofen and codeine.
- To limit the risks, the European Medicines Agency (EMA) has requested that these side effects be added to the summary of product characteristics (SPC) and the package leaflet.
- In France, all medicines containing codeine have been subject to compulsory medical prescription since 2017 (source: ANSM).
“Kidney and intestinal toxicity that can lead to death”, this is the risk that Antarene Codeine entails when taken in high doses or over a prolonged period, informed the National Agency for the Safety of Medicines and Health Products (ANSM) in a statement released yesterday.
What are the risks of Antarene Codeine?
Several cases of renal, gastrointestinal and metabolic toxicity have been reported in countries where it is available without a prescription: “Prolonged intake of this medication causes kidney damage (kidney failure) and a significant drop in blood potassium levels (hypokalemia) which may cause muscle weakness and impaired consciousness. Perforations and bleeding in the stomach or intestines as well as severe anemia have also been observed”, detailed the ANSM.
Antarene Codeine is a drug noted in case of acute pain of moderate to severe intensitywhich are not relieved by taking a analgesic only. It combines two painkillers, ibuprofen and codeine, an opiate molecule, like morphine.
The risk of abuse and dependence is therefore real: “If you feel the need to consume the drug Antarène Codeine in higher doses or longer durations than recommended, consult a doctor.”, advises the ANSM.
NSAIDs should be taken with caution
Ibuprofen, on the other hand, is one of the nonsteroidal anti-inflammatory drugs (NSAIDs), drugs that have in common four properties : anti-inflammatory (active against inflammation), analgesic (act against pain), antipyretic (help fight against fever) and platelet antiaggregation (thinning the blood).
There are rules for proper use when taking ibuprofen, as with all NSAIDs: “Use the lowest effective dose, for the shortest duration. Stop treatment as soon as symptoms disappear. Avoid NSAIDs for chickenpox. In case of fever, do not prolong the treatment beyond 3 days. In case of pain, do not prolong the treatment beyond 5 days. Do not take two NSAIDs at the same time”, recalls the ANSM.
It is rather advisable to favor paracetamol in case of pain and / or fever, especially in the context of a common infection such as sore throat or cough, taking care, however, to take the lowest dose, for the shortest possible time.