RADAR Finds Drug ReactionsMay 4, 2005 | www.redherring.com
Researchers in Chicago reported Wednesday they have found a large number of previously unknown and often fatal reactions to 14 commonly prescribed drugs and to drug-coated cardiac stents.
The report in the Journal of the American Medical Association is one of the results of an independent pharmaceutical surveillance program known as RADAR (Research on Adverse Drug Events and Reports Project), which looks at the safety of drugs already on the market.
The scientists from Northwestern University scoured academic journals, reports by pharmaceutical companies, and the U.S. Food and Drug Administrationâ€™s database for information about adverse reactions to common drugs.
They identified reactions that affected nearly 1,700 patients, and divided them into three groups of effects: death, severe organ failure, or cases requiring major interventions like CPR or liver transplantation.
The results show that 170 people died from adverse drug reactions. One novel cancer drug alone is associated with 67 deaths.
"RADAR has proved to be a powerful new instrument that supplements existing FDA surveillance systems and has helped save hundreds to thousands of patient lives," said Charles L. Bennett, program director.
The FDA has come under fire recently for not adequately policing the safety of marketed drugs. Several drugs have been withdrawn from the market or re-labeled to warn of additional side-effects.
"Itâ€™s the FDAâ€™s responsibility to make sure that the drugs which go on the market are safe and effective," said Elizabeth Boehm, a senior research analyst with Forrester.
New Jersey-based Merck withdrew its COX-2 inhibitor Vioxx on September 30, after studies showed the arthritis drug caused heart problems. Pfizer followed suit on April 7 with Bextra, and Biogen Idec and Elan suspended sales of multiple sclerosis drug Tysabri on February 28.
Suspicion has also been cast over common painkillers such as Advil, Motrin, and Aleve, as well as Sciosâ€™ heart drug Natrecor, and Novartisâ€™ epilepsy drug Trileptal.
These have prompted calls for post-market monitoring of drugs by independent groups of scientists, such as those involved in RADAR.
According to Ms. Boehm, some drugs are approved after a very short period of testing on the condition that they are continually monitored while on the market.
"Itâ€™s the follow-up on that which is under-resourced. Thatâ€™s the most politically sensitive way I can put it," she said. "The FDA is not staffed to monitor all of these drugs over the long haul."
Currently, itâ€™s largely up to drug companies to report safety issues once a drug is already for sale. "For good business reasons, they arenâ€™t going out there to seek out every adverse drug event," added Ms. Boehm.