Adverse Drug Reactions Reported to FDA Result in Negative Consequences
Leading drug safety expert Dr. Charles L. Bennett and a team of researchers just released results of a study of 15 drugs, including Levaquin and Cipro, and one medical device that revealed there were exceedingly negative consequences for patients, clinicians and manufacturers when very serious adverse drug reactions (ADRs) had been reported to the FDA. Among the highlights:
61% reported harms including verbal threats from manufacturers, and one lost a faculty position after reporting ADRs.
It took an average of 7.5 years for ADRs to be reported to the FDA.
It took another average of 7.5 years before the FDA issued warnings or removed one of the studied drugs or device from the market.
753,900 patients were awarded $38.4 billion in legal settlements by manufacturers for injuries purportedly caused by these 15 drugs and one medical device.
To qualify for the study, each item had to have generated at least $1 billion in sales, be identified as having high toxicity effects, have had very serious adverse effects reports, have generated at least $1 billion in legal settlements, had to have been considered for market removal by the FDA at one time, or have injured 1,000 or more patients. Because the impacts of ADRs are so large, researchers concluded that independently-funded pharmacovigilance centers of excellence should be established.
