The UK drug regulatory bodies (Medicines Control Agency and the committee on the Safety of medicines), in a rare request for self justification, have been asked to defend their recommendations on the dosage of pimozide, following the death of a patie
The dosage given the patient was 40 mg per day well within the limits of 60 mg set by the Data Sheet but twice that of the upper limit recommended by the US Food and Drug Administration. The US also limits the drug's use to Tourette Syndrome because of the drug's cardiovascular risks.
The CSM had cut the upper dosage to 20 mg, but only after it had received reports from doctors about problems of irregular heart beats and 13 deaths.
"This is one of many cases in which UK drug regulators seem to have failed to act, long after risks were known," charges Charles Medawar of watchdog agency Social Audit, who said it shows the shortcomings of voluntary reporting of drug side effects.