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Center for Molecular Medicine Only Regional Provider of Test Suggested in FDA Alert on Prescribing Codeine to Nursing Mothers

Tuesday, August 21, 2007 General News J E 4
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GRAND RAPIDS, Mich., Aug. 20 The Center for MolecularMedicine (CMM) today said it was the only lab in the Midwest capable oftesting nursing mothers for codeine risks cited in a Friday alert from theU.S. Food and Drug Administration (FDA).

Late Friday, the FDA issued an advisory noting new information about avery rare, but serious, side effect in nursing infants whose mothers aretaking codeine and are also ultra-rapid metabolizers of that drug. The FDAadvisory recommended physicians order a CYP2D6 genotyping test to determinehow the patient will metabolize codeine in advance of its prescription.

The FDA noted that when codeine enters the body and is metabolized, itchanges to morphine, which relieves pain. Many factors affect codeinemetabolism, including a person's genetic make-up. Some people have a variationin a liver enzyme (CYP2D6) and may change codeine to morphine more rapidly andcompletely than other people. Results from the FDA-approved CYP2D6 test,available at the CMM, tell a physician how rapidly a specific patient willmetabolize codeine based on a patient's genetic makeup.

"The CMM was created to offer physicians exactly this type of tool toprevent adverse drug reactions and better manage patient outcomes," said CMMExecutive Director Daniel H. Farkas. "It is vital that any area physicianscontemplating codeine for nursing mothers understand the critical need tocomplete a CYP2D6 test first in order to accurately determine how anindividual's body will process that drug at different dosages."

The CMM performs the CYP2D6 test using the FDA-approved AmpliChip(R)system created by Roche Diagnostics. Using the test, physicians can haveprior knowledge of how certain medications and levels of prescribed doses willaffect their patient before beginning treatment.

Approximately 25 percent of all prescription drugs are metabolized by theenzymes measured by the AmpliChip(R) test. The test need only be done once ina person's lifetime to provide a permanent and critical reference capable ofsignificantly improving care and reducing costs.

About the CMM

The Center for Molecular Medicine, a joint venture between Grand Rapids,Mich.-based Spectrum Health and Van Andel Institute (VAI), brings WestMichigan a cutting-edge laboratory that will aid in early diagnoses andenhance personalized medicine. It offers 21st century molecular technologiesfor investigation of complex diseases like cancer, heart disease, mentalillness and other conditions at the DNA, RNA and protein levels. The Centerbrings new and increased opportunities for diagnostics and pharmaceuticalcompanies to conduct trials in a world-class medical and clinical researchenvironment. For more information, visit www.cmmdx.org.

SOURCE The Center for Molecular Medicine
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