Drug regulators in the Republic have succeeded in blocking the reapproval of a commonly-used painkiller linked to liver failure following representations to a high-powered European Commission drug-safety body yesterday.
The anti-inflammatory drug nimesulide was taken off the market here last May by the Irish Medicines Board (IMB), but following a safety review by the European Medicines Agency (EMEA) in September it was declared safe to use.
The Irish Timesunderstands that the decision by the European Commission Standing Committee on Pharmaceuticals for Human Use to reject an EMEA recommendation is an extremely rare event, and reflects deep concerns expressed to the EU on behalf of a number of national drug-safety agencies.
The original decision to reapprove nimesulide, marketed under the trade names Aulin, Mesulid and Mesine, was very close, with a number of countries, including Ireland, Germany and the Netherlands, coming together to publish a dissenting opinion.
Had the decision by the EMEA been approved by the European Commission the drug could have been legally remarketed here.
The EMEA must now reconvene its committee for human medicines and carry out a full review of the drug's safety.
A spokeswoman for the IMB last night welcomed the European Commission decision.