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Drug Interactions: Implications for Pharmacogenetics in Drug Development

The recent withdrawal of cerivastatin, an effective and clinically popular HMG-CoA reductase inhibitor, highlights the perils of drug-drug interactions that afflict many drugs during their routine clinical use. Cerivastatin was first approved in the USA and the European Union in the middle of 1997 but on 8th August 2001, after a market life of just over four years, Bayer Pharmaceuticals announced that, with immediate effect, they were withdrawing the drug from the markets worldwide. Following post-marketing experience, a major safety-led change was introduced in December 1999 to contraindicate the concurrent administration of cerivastatin and gemfibrozil. However, by August 2001, clinical use of cerivastatin was associated with 31 fatalities due to rhabdomyolysis in the USA. In 12 (39%) of these, cerivastatin was coadministered with gemfibrozil.

Cerivastatin represents the most recent example in a long list of many valuable drugs that have been lost because of their drug interaction potential. Other drugs withdrawn from the market since 1993 due to clinically significant drug interactions observed during their routine clinical use, are shown in Table 1.

Many factors may interact with a drug to alter its disposition or a patient's response to it. These include age, gender, diet, social habits (for example consumption of tobacco or alcohol), physical activity and pathophysiologic states (for example co-morbidity, menstruation). By far the most important factor, however, is the coadministration of another drug resulting in a drug-drug interaction. This brief review is concerned with only the drug-drug interactions.

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By Dr Rashmi R Shah, Senior Medical Officer at the Medicines Control Agency

Dr Rashmi Shah has been a Senior Medical Officer at the Medicines Control Agency, London since 1987. He qualified in medicine from St Mary's Hospital Medical School and is a fellow of the Royal College of Physicians and the Faculty of Pharmaceutical Medicine. He was part of the team that first characterised CYP2D6 and its clinical significance. He was awarded a Doctorate in Medicine for his research into the role of this enzyme in predisposition to perhexiline-induced neuropathy.

His special interests are drug interactions, pharmacogenetics, cardiotoxicity and stereoselectivity in drug toxicity. He has extensive experience in the evaluation of new chemical entities and has played a major role in drafting a number of CPMP guidelines, including the ones on drug interactions, congestive heart failure and investigation of the potential of non-cardiovascular drugs to prolong the QT interval. He currently represents the UK on the Committee for Orphan Medicinal Products and the Scientific Advice Review Group of the Committee for Proprietary Medicinal Products.

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Dr Rashmi Shah
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