HEALTHFDA approves genotype test for drug responseGenetic medicine experts hope this test will lead to a reduction in adverse medication reactions.By Victoria Stagg Elliott, amednews staff. Jan. 31, 2005. The Food and Drug Administration approved the first DNA microarray test that indicates whether a patient is more or less likely to experience side effects from several common heart drugs, antidepressants and chemotherapy agents. The agency last month gave its nod to the AmpliChip Cytochrome P450 Genotyping test for use with the Affymetrix GeneChip Microarray Instrumentation system. "Physicians can use the genetic information from this test to prevent harmful drug interactions and to assure drugs are used optimally, which in some cases will enable patients to avoid less effective or potentially harmful treatment choices," said Acting FDA Commissioner Lester M. Crawford, DVM, PhD. Experts praised the agency's action for providing a uniform tool that may lead to more personalized prescribing. P450 testing is carried out currently, usually in a research setting, but standards vary widely. "It's a great step forward," said Floyd Sallee, MD, PhD, vice chair of psychiatry at the University of Cincinnati. Dr. Sallee authored a case study in the spring 2000 Journal of Child and Adolescent Psychopharmacology about a 9-year-old boy who died from an overdose of fluoxetine. Postmortem testing revealed polymorphisms in his P450 gene family. But while the FDA decision received praise, many questions persist about exactly how this new tool should be used and whether testing would be most appropriate when making a prescribing decision or just when side effects appear. [...]Full text of American Medical News content is available to AMA members and paid subscribers.
Copyright 2005 American Medical Association. All rights reserved.
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From the vault: 5 years agoGenetic testing issues land in primary care practices Nov. 8, 2004 
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