Controversial FDA Panel Approves Drug For Use By Children; New DNA Test Alerts Physicians And Parents To Potential Harm

Main Category: Arthritis / Rheumatology
Also Included In: Genetics;  Pediatrics / Children's Health
Article Date: 08 Dec 2006 - 0:00 PST

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An FDA advisory panel's recommendation to allow Celebrex to be marketed for children suffering from juvenile rheumatoid arthritis (JRA) has some experts concerned over long-term health effects.

While the issue of short-term efficacy and safety did not seem a big issue with the FDA panel, long term safety was a matter of concern.

The disease affects some 60,000 children nationally. Celebrex is a member of the COX2 inhibitor class of drugs that include Vioxx and Bextra, both pulled from the market by the FDA because of serious or fatal heart-related injuries or stroke associated with the drug.

According to Howard Coleman, CEO and Founder of Genelex Corporation (Seattle), "thousands of children have an inability to process Celebrex safely. A simple DNA test that tests for the CYP2C9 enzyme alerts parents and physicians that the drug could cause harm to the child." It is estimated that 5 percent of the population has trouble processing Celebrex. If the drug is inadequately processed, it can build to dangerous levels in the bloodstream.

"No medicine that could potentially harm patients should ever be prescribed without knowing how that individual processes the drug. It is time patients and parents responsibly determine how a drug will affect them before it is ever swallowed," continued Coleman.

Adverse drug reactions are responsible for more than 100,000 deaths in the US every year.

Strattera, another drug approved by the FDA for use by children suffering from ADHD, can cause serious damage to the liver -- damage that could be averted.

"Celebrex, Strattera and hundreds of other prescriptions, are potentially very helpful medications," Coleman stated. "Correspondingly, doing appropriate DNA testing in advance would save lives."

Genelex provides consumer-friendly DNA tests that determine whether prescription, over the counter, and herbal remedies are potentially harmful to the patient.

The tests, available to the public without prescription at http://www.genelex.com/, are simple to take. DNA is captured by vigorously rubbing the inside of the cheeks with a swab. The swabs are sent to Genelex for testing. Results are sent directly back to the patient, who may share the results with their physician or pharmacist.

For further information, contact Howard Coleman, President and Founder of Genelex (Seattle), at 206-382-9591.

Genelex Corporation
http://www.genelex.com/