June 6, 2005

Contact: Angela Heisel, 272-3651

FOR IMMEDIATE RELEASE

Every year the U.S. Food and Drug Administration (FDA) receives 300,000 calls regarding serious adverse effects of prescription drugs. Adverse drug and device reactions (ADRs) also account for as many as 100,000 deaths annually. Prior to FDA approval, drugs are evaluated in well-designed and carefully monitored clinical trials, but more than half of the most serious adverse drug reactions have been discovered seven or more years after a drug has been marketed.

To help track and identify which drugs are causing adverse side-effects in patients, Dennis Raisch, associate professor at the UNM College of Pharmacy, has been working with the National Institutes of Health to investigate and disseminate information on describing serious and previously unrecognized adverse drug and device reactions.

Raisch and a team of multidisciplinary researchers have been working with a monitoring program developed by a Northwestern University researcher who has successfully identified a large number of previously unknown, serious and often-fatal drug reactions associated with 15 commonly used drugs, including Plavix®, thalidomide and drug-coated cardiac stents.

This new, clinically based, hypothesis-driven approach to post-marketing surveillance may supplement existing regulatory surveillance systems and improve patient safety. " Our goal is to recognize these serious effects as quickly as possible," Raisch said. "When one person out of twenty-six thousand people suffers one of these ADR's we want to inform physicians of signs of the adverse experience to keep that from happening to another patient."

Raisch said that rapid treatment or discontinued use of the drug is key but there are many obstacles in getting physicians to recognize that a symptom is caused by a certain drug or device.

Adverse drug reactions are classified as resulting in death, severe organ failure or requiring major therapeutic interventions, such as cardiopulmonary resuscitation, liver transplantation or placing an individual on a respirator.

The mission of the college is to develop innovative leaders in pharmaceutical care and research who enhance the quality of life for the people of New Mexico . For more information on the UNM College of Pharmacy, please visit http://hsc.unm.edu/pharmacy/.