L’Emathe European Medicines Agency, has given new indications on the combined use of two active substances contained in commonly used medicines, which could cause severe danni to the organism and even lead to death if prolonged over time and with higher doses than those recommended by the health authorities. This is the codeine andibuprofenan opioid and an anti-inflammatory that are frequently prescribed for the treatment of pain.
Repeated use of codeine and ibuprofen together can also lead dependence e all’abuse of drugs that contain them due to the properties of the opiate.
Change the package insert of codeine and ibuprofen: the new side effects
The Pharmacovigilance and Risk Assessment Commission of EMA has examined several cases of toxicity renal, gastrointestinal and metabolic reported in association with intake, abuse and dependence on a combination of codeine and ibuprofen. In many of which the outcome was the death.
Prolonged use in high doses of the two active ingredients combined causes damage to the kidneys, creating an accumulation of acids in the blood (renal tubular acidosis or ATR). Malfunction of the kidneys can also lead to a low concentration of potassium in the blood (hipokalemia), which can cause symptoms such as weakness muscular e dizziness.
All these effects on the organism will therefore be added to leaflets of medicines containing codeine and ibuprofen as new side effects. But the decisions of the EMA are not limited only to the modification of the leaflets.
What changes for the prescription of combinations of codeine and ibuprofen in Italy
There are drugs on the market that contain both molecules, whose combination it is authorized at national and non-EU level. These medicines can also be purchased in Italy. For this reason, the EMA has alerted the competent authorities, in our case Aifa, which in turn will have to update professionals and patients on the risks and damage caused by the abuse and dependence of combined codeine and ibuprofen.
From the assessments of the Pharmacovigilance and Risk Assessment Commission of the EMA it has also emerged that these types of medicines are often supplied in different countries without prescription medica.
In Italy the non-repeatable medical prescription (RNR), and therefore before purchasing the drug it is always necessary to have the authorization of your general practitioner. Also in other states it is not possible to buy combinations of codeine and ibuprofen. However, many patients may be able to get their supplies online – at the risk of buying counterfeit products among other things, as explained here.
For this reason, the indication of the EMA to the member countries of the European Union is to render mandatory the prescription of these categories of drugs throughout the Community. Furthermore, the Commission stresses that doctors should pay even more attention to the patient’s history and possible inclination to addiction and drug abuse before prescribing the two molecules in combination.
Speaking of medicines, from today it could be very difficult to find a long series of medicines in Italy, as anticipated here. At the base of the shortage of products even in pharmacies, there are increases and inflation, which has now reached a record level. We told you about it here.