The Research on Adverse Drug Events and Reports (RADAR) system has successfully uncovered previously unknown, serious reactions among 14 commonly used drugs, according to a report published in the Journal of the American Medical Association (May 4, 2005). Investigators have found that in the past 6 years the drug-monitoring system went beyond the FDA's information gathered after new drugs entered the marketplace.
The FDA's reporting system relies on information voluntarily submitted by pharmaceutical companies and physicians through the Adverse Events Reports System and the Manufacturers' User and Device Experience. The researchers noted that the flaw in these systems is that they require sifting through huge amounts of data to uncover safety issues.
The RADAR system is formatted differently. Instead of relying on huge databases, it starts with 25 physicians at academic medical centers located in Chicago, Albuquerque, San Antonio, Salt Lake City, and New Orleans. These physicians have their clinical "ears to the ground." If something has potential, word goes out to a broad group of clinicians, and researchers search for other cases.
To date, RADAR has detected 16 serious, often deadly, and previously unknown types of drug and medical device reactions connected with 14 commonly used drugs. The medications include the anemia drug epoetin, the cancer drug gemcitabine, and the drug ticlopidine, used to lower the incidence of strokes. The system has picked up serious adverse drug reactions in 954 patients. Of these patients, 169, or 18%, died. Although some of the data came from the FDA's own files, RADAR was able to find a pattern of adverse reactions faster than the FDA.
Timeliness is imperative in saving lives, said study author Charles Bennett, MD, PhD. Every year adverse drug reactions account for 100,000 fatalities. The FDA has mandated that manufacturers add 45 drug reactions to package inserts. Identifying more than half of these reactions, however, took more than 7 years after the drugs had been approved. "Our goal is to decrease that to 11/2 to 2 years," said Dr. Bennett.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
Clinical features with downloadable PDFs