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Wednesday, November 30, 2022

Drugs with ibuprofen and codeine, Ema: “They can damage kidneys and intestines”

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The Pharmacovigilance Committee of the European Medicines Agency has commissioned an update of the package leaflet of medicines containing codeine and ibuprofen to highlight the possibility of harm related to the use of the medicines, in particular when they are taken for longer periods and in doses higher than those recommended

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The combination of codeine and ibuprofen can “cause severe kidney and gastrointestinal damage.” This was stated by the Pharmacovigilance Committee (Prac) of the European Medicines Agency, which has ordered an update of the package leaflet for medicines containing codeine and ibuprofen to reduce the possibility of harm, including death, associated with the use of medicines. especially if taken for longer periods and in doses higher than recommended. Among the drugs containing codeine and ibuprofen we find Brufecod, a drug indicated for the symptomatic treatment of mild to moderate pain in adults, if it is not sufficiently relieved by other analgesics.

Risky combination

The combination of codeine (an opioid analgesic) and ibuprofen (one of the most popular anti-inflammatories) is used in the treatment of pain. At its Sept. 26-29 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) analyzed several cases of renal, gastrointestinal, and metabolic toxicity associated with drug abuse, often linked to codeine addiction. Some of them have been fatal. In particular, the committee focused mainly on kidney damage, pointing to the addition of tubular acidosis (a complication that causes acid buildup in the blood) and hypokalaemia (ie low levels of potassium in the blood) as possible side effects of the drug.
The committee also suggested adding messages to make it clear to patients that they should consult their doctor if they plan to take the drug for longer periods or at higher doses than recommended. In addition, he recalled that in the European Union there are medicines containing codeine and ibuprofen that can be bought by patients without a prescription. Since most cases of complications have occurred in countries where the drugs are available without a prescription, the committee recommends limiting access to submitting a prescription.

In Italy you need a doctor’s prescription

In Italy, the drug is available on prescription to be renewed from time to time. In addition, the package insert already calls for caution when using the product in patients with addiction. With regard to renal complications, in patients with mild renal impairment it is recommended to use it at the lowest possible dose. The drug, on the contrary, is completely contraindicated in patients with severe renal insufficiency.

Source: TG 24 Sky

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