Taking a drug that combines ibuprofen and codeine in higher doses than prescribed can be fatal.
The European Medicines Agency (EMA) issued a warning this week regarding the consequences of taking these two drugs, an anti-inflammatory and an over-the-counter alkaloid in pharmacies in some European countries.
The EMA’s Pharmacovigilance Risk Assessment Committee recommends that the package insert for these drugs should include a warning once morest “serious harm, including death, especially if taken for prolonged periods at doses above recommended ones”.
“The committee reviewed several cases of renal, gastrointestinal and metabolic toxicity that have been reported in association with cases of codeine abuse and dependence, with ibuprofen combinations, some of which have been fatal,” adds the European Medicines Agency.
Ibuprofen is one of the most widely used analgesic, antipyretic and anti-inflammatory drugs in the world.
It belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs) along with aspirin, ketoprofen and naproxen, among others, and works in the body by reducing hormones that cause pain and swelling.
Codeine is an opioid, like morphine or oxycodone. When it enters the body, a small part of the substance is transformed into morphine and acts on the central nervous system and the brain to block pain.
It is used to treat moderate or severe pain when paracetamol, aspirin or ibuprofen alone are not enough. It is also recommended for cough reduction when other medications have not worked.
Codeine also reduces anxiety and stress caused by pain.
“Codeine has historically been used postoperatively, following minor surgeries. If you have your tonsils removed or you have minor surgery, you may be told to take codeine for a few days,” she told BBC Mundo Peter Chai, emergency physician and medical toxicologist at Harvard University Medical School.
Mr. Chai said that in the United States, codeine is combined with paracetamol rather than ibuprofen, but this opioid is still out of use due to its disadvantages, including the fact that each person metabolizes it “in very different ways and at very different rates”.
Another major downside of codeine is that it is addictive, so using it for more than three days is not recommended.
“There are two aspects to consider in a combination pill of codeine and ibuprofen. There is definitely abuse potential for codeine because it is an opioid like morphine, oxycodone or hydromorphone” , Mr. Chai said.
“But if someone is abusing or addicted to codeine co-formulated with ibuprofen, they are in trouble because there are known toxicities, which are associated with ibuprofen such as gastrointestinal symptoms and kidney damage,” he added.
EMA reports that when this drug is taken in higher than recommended doses or for a prolonged period of time, it may cause renal tubular acidosis, which is damage to the kidneys that prevents them from properly eliminating blood acids in urine.
Poor kidney function can lead to very low potassium levels in the blood, causing muscle weakness and dizziness.
In older people who already have kidney or blood pressure problems, ibuprofen can also cause kidney damage because it decreases blood flow to that area, Peter Chai explained.
“There has been a push to move away from these combination products because they bring problems to those who use them,” said the expert and professor at Harvard University.