Drug Reactions on the Rise

unduhan-17If you’ve ever gotten a rash from taking an antibiotic or gained weight on an antidepressant, you know that taking medicine means balancing the benefit of the drug against the possible risk of unpleasant, and sometimes even dangerous, side effects. The U.S. Food and Drug Administration (FDA) calls these unwanted consequences “adverse events,” and once a drug is on the market, watches closely to see if it needs to reevaluate a drug’s safety. FDA does this in part through their MedWatch program, where health professionals and the general public can report any reactions or problems they suspect may have been caused by a medication. Medwatch reports and those submitted by drug manufacturers are combined into a single database for drug safety evaluation, the Adverse Event Reporting System (AERS).

According to a study recently published in the Archives of Internal Medicine, the reporting of serious adverse events through AERS (those that can lead to hospitalization, significant health problems, or even death) has increased dramatically in recent years — a 2.6-fold increase in serious events and a 2.7-fold increase in deaths reported between 1998 and 2005 (the last year for which data was available for the study).

In fact, half of the 2.2 million total reports in the database since its inception in 1969 were received in just the past 10 years, the study found, increasing at a rate of more than 11 percent per year. Slightly more women than men had adverse events (55 percent compared to 45 percent).

Does This Mean Our Medicines Have Become More Dangerous?

Not necessarily, says the study’s lead author, Sheila Weiss Smith, PhD, director of the Center for Drug Safety at the University of Maryland. The spike could be due to several factors:

  • Greater awareness of the reporting system
  • Access to the Internet, making it easier for people to report problems than the old system (in which you had to call, fax, or mail a report to FDA)
  • The fact that people are taking more drugs for longer periods of time (thus increasing the potential for side effects, as well as interactions between drugs)
  • The aging of the U.S. population (older people often experience more problems with drugs)