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Center for Molecular Medicine Only Regional Provider of Test Suggested in FDA Alert on Prescribing Codeine to Nursing Mothers
Date:8/20/2007

GRAND RAPIDS, Mich., Aug. 20 /PRNewswire/ -- The Center for Molecular Medicine (CMM) today said it was the only lab in the Midwest capable of testing nursing mothers for codeine risks cited in a Friday alert from the U.S. Food and Drug Administration (FDA).

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

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

"The CMM was created to offer physicians exactly this type of tool to prevent adverse drug reactions and better manage patient outcomes," said CMM Executive Director Daniel H. Farkas. "It is vital that any area physicians contemplating codeine for nursing mothers understand the critical need to complete a CYP2D6 test first in order to accurately determine how an individual'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 have prior knowledge of how certain medications and levels of prescribed doses will affect their patient before beginning treatment.

Approximately 25 percent of all prescription drugs are metabolized by the enzymes measured by the AmpliChip(R) test. The test need only be done once in a person's lifetime to provide a permanent and critical reference capable of significantly 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 West Michigan a cutting-edge laboratory that will aid in early diagnoses and enhance personalized medicine. It offers 21st century molecular technologies for investigation of complex diseases like cancer, heart disease, mental illness and other conditions at the DNA, RNA and protein levels. The Center brings new and increased opportunities for diagnostics and pharmaceutical companies to conduct trials in a world-class medical and clinical research environment. For more information, visit http://www.cmmdx.org.


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SOURCE The Center for Molecular Medicine

Copyright©2007 PR Newswire.

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