MORE NEWS ON TORADOL IN EUROPE

European Union members are split over the risk-benefit ratio of the injectable form of the post-operative painkiller ketorolac (Syntex' Toradol), according to a pharmacovigilance opinion issued by the EU's Committee for Proprietary Medicinal Products.

Germany, Greece, France, the Netherlands and Portugal consider that the interim restrictions on Toradol use which the CPMP recommended last June are inadequate, and that the injectable product's risk-benefit ratio is unfavorable based on currently available data. Belgium, Denmark, Spain, Italy, Luxembourg and the UK feel that the risk-benefit ratio justifies the drug continuing to be used under restricted conditions. Ireland says that it cannot authorize the product until the results of a comparative study on efficacy and safety have been submitted and reviewed.

Thus, while the majority of CPMP members have backed limited ketorolac use, some countries are still reluctant to lift the suspension. It has never been sold in the Netherlands, Greece and Portugal, and Syntex ceased supplies of the drug to Germany in June 1993. France suspended the drug's product license in December pending the CPMP review.