Dangers of over the counter codeine medications not made clear enough to consumers with risk of severe kidney damage outlined as part of investigation

Serious risk from codeine-containing medicines were not being spelled out clearly enough in product information, according to a report from the Irish Health Products Regulatory Authority (HPRA).

The HPRA is currently leading an EU investigation of the controversial combination painkillers following research on serious adverse reactions, including fatalities, for people who had developed dependence on the drugs.

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” as a result of a dependence that had developed.

The HPRA said healthcare providers needed to be alerted to the risk and to raise patient awareness of “the potentially clinically significant consequences of codeine addiction”.