Ireland Reviewing Codeine's OTC Status
Executive Summary
Ireland’s drug regulator HPRA has initiated a formal regulatory procedure to determine if OTC remains the appropriate classification for codeine-containing products. The agency says the move is in response to a growing understanding of the potential impacts of addiction to codeine at low doses.
You may also be interested in...
OTC Codeine Cough Syrups Meet UK Conditions For Rx Reverse Switch, Says Expert Body
Could codiene linctus cough syrups be reverse-switched from OTC to Rx status in the UK? A panel of independent medicines experts suggests they should be, based on UK drugs law and their use in illegal cocktail Purple Drank.
Estonia Ends OTC Access To Codeine
Concerns over addiction to, and deliberate misuse of, codeine in Estonia has led the national regulator to reverse-switch the opioid from OTC to prescription-only status.
EMA Specifies New Warnings For Codeine/Ibuprofen Combination Drugs
A warning about the risk of severe hypokalemia and renal tubular acidosis is set to be added to the product information of fixed dose combinations of codeine and ibuprofen marketed in the EU following an investigation by the EMA's PRAC.