18 Million Serious Drug Reactions Occur Each Year

The Food and Drug Administration received an astonishing 179,855 reports of serious or fatal adverse drug reactions in 2011. These reports came voluntarily through health professionals or consumers, while a majority of the other reports came from drug manufacturers. Drug manufacturers are required to report adverse drug reactions within 15 days of becoming aware of a serious reaction.

You might not be aware that most serious drug reactions are caused by a ten drugs–Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim. Pradaxa caused the most serious events, such as death, hemorrhage, acute renal failure, stroke and liver failure. Overall, most of these drugs carry serious FDA warnings, suggesting that placing warnings on drugs does not solve the entire problem of managing risks.

It is estimated that only about 1% of adverse drug reactions are reported, with a majority coming from manufacturers. This makes it more likely that 179,855 adverse reactions is a conservative estimate and that it is more likely that there are 18 million serious reactions each year. Surveillance programs, like Quarterwatch, monitors all adverse drug reactions and reports to the FDA. Programs such as these can help stem the problem of serious adverse drug reactions, but it is equally important that consumers and health providers also do their part to report adverse reactions.