Evaluating the safety of drugs
The post-marketing surveillance of new drugs is described, particularly the prescription event monitoring carried out by the Drug Safety Research Unit. Case histories of the prescription event monitoring of the calcium antagonists, amlodipine, nicardipine, isradipine and diltiazem; the anti-inflammatory nabumetone; and the angiotensin II antagonist losartan are given. The paper concludes that prescription event monitoring provides important information on drug safety in large cohorts of patients and can also help allay fears about particular drugs. It does not contribute significant new data on drug efficacy.