A report published in the September issue of Archives of Internal Medicine pinpoints the concerning fact that the number of adverse events caused by drugs have increased alarmingly in the last years. According to the report’s findings the adverse events caused by drug administration reported to the US Food and Drug Administration through its MedWatch system has almost doubled between 1998 and 2005.

The report, which was conducted by Thomas J. Moore, A.B., of the Institute for Safe Medication Practices, Huntingdon Valley, Penn., and colleagues, concluded that during the analyzed period the deaths caused by adverse drugs events had registered a similar tendency.

According to the report in the seven years period a number of 467,809 serious adverse events were reported to the FDA, with a 2.6-fold increase from 34,966 to 89,842.  As for the fatal adverse drug events, they increased 5,519 to 15,107 in the same time frame.

The report also identified the drugs related to the adverse events. A total of 1,489 drugs were associated with adverse events, but a subset of 51 drugs that each had 500 or more reports in any year accounted for 203,957 or 43.6 percent of the total adverse event reports in the study. The dangerous drugs include painkillers like Oxycontin, sold generically as oxycodone, but also insulin, arthritis drugs like Vioxx and Remicade, and antidepressant Paxil.

“Contrary to our expectations, drugs related to safety withdrawals were a modest share of all reported events and declined in importance over time,” the authors write. In the subset of 51 drugs with 500 or more reports in a year, the percentage of reported events associated with drugs related to safety withdrawals declined from 26 percent in 1999 to less than 1 percent in 2005. “Among the most frequently reported drugs associated with fatal events, we observed a disproportionate contribution of pain medications and drugs that modify the immune system”, the authors added

According to the report elderly patients were more frequent in reporting adverse effects, and the number of women affected outstripped the men’s, 55.5 percent compared to 45.5 percent, respectively. Children were reported in only 7.4 cases, fortunately.

Based on their discoveries, the authors said that a new system to manage the risks of prescription drugs is needed because the existing one is not adequately protecting patients and underscores the importance of recent reports urging far-reaching legislative, policy and institutional changes.

FDA’s response came rapidly, highlighting that what is happening is alarming, but the exact cause of it is still not known.

“While some of this has to do with the increasing number of prescriptions, there are clearly other factors responsible for this increase, such as the increase in public attention to drug safety, and use of the Internet to make it easier for the public to submit,” Dr. Gerald Dal Pan of the FDA's Surveillance and Epidemiology Office said quoted by AP.