JAMA is running a report on the new RADAR System (Research on Adverse Drug Events and Reports). Current FDA-led information-gathering relies on voluntary pharmaceutical company disclosures, and takes years to generate new warnings. RADAR may be faster and more complete. From USA Today:
Instead of relying on huge databases, it starts with 25 doctors at academic medical centers in Chicago, Albuquerque, San Antonio, Salt Lake City and New Orleans with clinical “ears to the ground” looking for potential adverse events. When any of them sees something that looks interesting, word goes out to a broad group of clinicians, and researchers search for other cases.
So far they’ve found 16 serious, often-fatal and previously unknown types of drug and medical device reactions associated with 14 commonly used drugs, the report says. These include the anemia drug Epoetin, the cancer drug Gemcitabine and the drug Ticlopidine, used to reduce the chance of strokes. All told, RADAR has picked up serious adverse drug reactions in 954 patients, of whom 169, or 18%, died as a result of the reaction. Some of the data came from the FDA’s own files, but RADAR sometimes was able to find a pattern of adverse reactions more quickly than the FDA.
More at JAMA…