Last year, the FDA received nearly 180,000 reports of serious, disabling, and fatal adverse drug events in the United States – most of them through drug makers – that affected up to 4 million Americans, which makes an industry watchdog group wonder if anybody out there cares. “In fact, the 2011 data illustrate that many of the reports of patient deaths from drug manufacturers are of such low quality as to be nearly useless,” according to a shocking analysis from the Institute for Safe Medication Practices' QuarterWatch.
“(Drug) therapy stands as one of the most significant perils to health resulting from human activity. Major health benefits can be achieved through safer medication use, which should be a much higher priority for medicine, government, and the public,” according to the group.
The two most complained-about drugs were the anticoagulants dabigatran (brand: Pradaxa) and warfarin (Coumadin), which shows “that the combination of a vulnerable patient population and a powerful pharmacological action rank among the highest risks in prescription drug therapy,” the group says. “While a therapeutic goal of preventing strokes, pulmonary embolism, and other harm through unwanted blood clots is a worthy objective, these results demonstrate that treatment is accompanied by substantial risks. We identified both similarities and differences between the two widely used anticoagulant drugs.”
Last year, there were twice as many adverse drug event reports connected to lawsuits against drug manufacturers for alleged patient injuries – 43,819 – as it had direct reports made through health professionals and patients, QuarterWatch said. “On one hand, if tens of millions of dollars are being spent in litigation on behalf of thousands of patients, it is often a signal of a major drug safety issue,” the report said. “On the other hand, the filing of a lawsuit claiming that a drug caused harm is not proof that a drug-induced injury occurred.”