The number of serious adverse drug events (ADEs) reported to the FDA has more than doubled in recent years, according to a new analysis from the Institute for Safe Medication Practices.Between 1998 and 2005, ADEs increased 2.6-fold (from 34,966 to 89,842), while the number of fatalities almost tripled (from 5,519 to 15,107). However, the rate of fatalities was fairly stable, accounting for 15.8% of events in 1998 and 16.8% in 2005.
“The overall relative increase was four times faster than the growth in total U.S. outpatient prescriptions, which grew in the same period from 2.7 billion to 3.8 billion,” the authors wrote (Arch Intern Med. 2007;167:1752-1759).
A small minority of medications accounted for 87% of serious ADEs. Of the top 15 drugs associated with fatalities, seven were pain medications and four were directed at the immune system.
Meanwhile, a study at the University of California, San Diego School of Medicine suggests that ADEs may be underreported.
Researchers wanted to assess how doctors responded to patient complaints about ADEs. They surveyed 650 adults who believed they had suffered common side effects of statins, such as muscle pain, numbness, or memory loss. In most cases, the patients’ concerns were brushed aside. The clinicians blamed the symptoms on aging, denied the symptoms could be connected to the drugs, or simply dismissed the complaints.
“Rejection of a possible connection was reported even for symptoms with strong literature support for a drug connection, and even in patients for whom the symptom met presumptive literature-based criteria for probable or definite drug adverse effect causality,” the researchers wrote (Drug Saf. 2007;30:669-675).