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Britain okays banned drug
About the author: 
WDDTY Team

Britain is one of six countries in the European Union (EU) to continue marketing the post-operative painkiller ketorolac (Toradol)

Britain is one of six countries in the European Union (EU) to continue marketing the post-operative painkiller ketorolac (Toradol).

Five other countries are worried that restrictions on the drug are not adequate, while the six including Britain are satisfied that the risk benefit ratio is favourable under restricted use.

Ireland is refusing to authorize the drug until it has studied the results of a comparative study on efficacy and safety, and the drug has never been granted a licence in The Netherlands, Greece and Portugal. Supplies to Germany were stopped in June last year, and it was suspended in France last December.

The restrictions were imposed by the EU Committee for Proprietary Medicinal Products in June 1993 after the Dutch authorities asked it to consider the risk benefit ratios in the light of 80 fatalities linked to the drug.

The manufacturer, Syntex, was given until last December to submit final reports, and it had a hearing with the committee in March.

The other countries to approve its limited usage are Italy, Belgium, Denmark, Spain and Luxembourg.


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