Dangers from codeine-containing medicines were not being spelled out clearly enough in the packaging, a new report claims.
The Irish Health Products Regulatory Authority is leading an EU investigation of controversial combination painkillers.
It follows research on serious adverse reactions – including fatalities – for people who had developed dependence on the drugs.
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A report said in addition to well-known “toxicities” from the anti-inflammatory products in the over-the-counter medications, there was also a risk of severe kidney damage from long-term use.
It detailed the development of “severe hypokalaemia in the setting of renal tubular acidosis” following continuous use or misuse of the codeine medications.
The report said this was a “new concern” that had not been properly reflected in product information for codeine and ibuprofen combination drugs. It said the condition appeared in patients where there was “prolonged chronic abuse”.
The HPRA said healthcare providers needed to be alerted to the risk and to raise patient awareness of “the potentially significant consequences of codeine addiction”.
The report described a large number of cases where patients had developed severe issues from overuse of the codeine combination medication.
In one case, a woman had been taking up to 32 tablets almost every day for two months before developing severe renal issues. Another case detailed a woman who had taken 40 codeine combination pills daily for five weeks to try to deal with migraines.
They were among dozens analysed in a review of red flags from hospitals across the EU about over-the-counter codeine medications.
The report said there had also been numerous “fatal reports” as well in which “codeine-ibuprofen dependence appears to have been a significant contributor to the patients’ death”.
And there where were cases of intentional overdose, accidental overdose, and intentional misuse. The report said it was of note that many of those who were becoming ill were relatively young and “without significant comorbidity” – an illness that would otherwise explain their poor state of health.
It added: “[These] represent otherwise healthy patients in whom an addiction to codeine is resulting in serious clinical outcomes as a result of exposure to chronic high doses of ibuprofen.”
The report said it was “paramount” that additional risks from use of codeine ibuprofen medications were highlighted in addition to the “known risks of dependence and addiction”.
And it concluded by saying that countries where such medications were available over-the-counter should consider the continued “appropriateness” of that.
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