They warn of the risk, even fatal, of combining ibuprofen and codeine

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The EMA warns that taking drugs that combine ibuprofen (anti-inflammatory) and codeine (opioid) – used to treat pain – for a long time or in doses higher than recommended can cause serious damage, and even death.

The prolonged consumption of drugs that combine ibuprofen and codeine is harmful to health and can have serious consequences, including death, as the European Medicines Agency (EMA) has just warned, so the EMA Safety Committee It has recommended that the possible harm that the patient may suffer – especially when taking them for a long period of time or in higher doses than recommended – be added to the information (package inserts and technical data sheets) on the side effects of drugs containing both substances.

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) that is used to relieve mild and moderate pain, among other conditions. Codeine is an opioid with analgesic properties that is also used as a sedative and antitussive (to calm coughs). Combining these two active ingredients is an advantage because, as their mechanisms of action are completely different, using both at the same time obtains a more powerful therapeutic effect and allows moderate pain to be treated without the need to resort to more powerful opioids.

Long-term use of ibuprofen with codeine damages the kidneys

The EMA Safety Committee has reviewed several cases of people who suffered serious kidney, gastrointestinal and metabolic damage that had been reported and were related to the abuse and dependence on the combination of ibuprofen with codeine, and in which the death of the patient. The EMA also indicates that repeatedly combining the opioid codeine with the anti-inflammatory ibuprofen can lead to codeine addiction.

The EMA has detected cases of serious kidney, gastrointestinal and metabolic damage related to the abuse and dependence on the combination of ibuprofen with codeine, which ended with the death of the patient

The conclusion reached by this body after carrying out the analysis is that the repeated use of drugs that combine ibuprofen with codeine and at higher doses than recommended causes damage to the kidneys and prevents them from being able to adequately eliminate acids from the blood causing renal tubular acidosis. Failure of the kidneys to perform well can also cause blood potassium levels to drop, leading to muscle weakness and dizziness, so he recommends adding renal tubular acidosis and low potassium as new effects side effects in the information on the combination of ibuprofen with codeine.

The EMA has warned that most of the cases of adverse effects detected have been found in countries where this combination of drugs is available over the counter and does not require a prescription, so to reduce the risk it advises that they become prescription drugs. In Spain, the most used type of opioid is the combination of ibuprofen and codeine –the tenth most used type of opioid, which accounts for 1.17% of the total consumption of this type of drug–, according to data from the Ministry of Health, although its use has been reduced by 71% in the last 10 years.

The prospectuses and technical data sheets of these drugs will now include warnings about the risks identified by the EMA, although these changes will take time. A spokesman for the Spanish Agency for Medicines and Health Products (AEMPS), dependent on the Ministry of Health, has stated that they are preparing a note to inform the health system about the EMA’s conclusions, and according to sources from this body in Spain “no it is necessary to adopt more measures, such as the withdrawal of medicines or warnings to the population”.

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