May 27, 2011 -- If you flip through a consumer magazine and come across a prescription drug ad or even glance at a medication package insert, you will likely find a long list of potential side effects, many of which may be frightening.
Some doctors contend that this is information overload and may have a chilling effect on some people who could benefit from certain prescription medications.
A new study in Archives of Internal Medicine puts a number on it. The average prescription drug label lists 70 potential side effects, and many of the more commonly prescribed medications list around 100-such risks. One medication in the study lists 525 potential side effects.
“It has gotten out of control,” says Jon Duke, MD, an assistant professor of medicine at Indiana University School of Medicine in Indianapolis and a researcher at the Regenstrief Institute. “These are 20,000- to 30,000-word massive documents.”
Warnings on Drug Labels
In 2006, the FDA set rules to make drug labels easier to read and understand and reduce "overwarning” on drug labels, but this may have had the opposite effect.
In the new study, researchers analyzed 5,600 drug labels comprising 500,000 side effects. Antidepressants and antiviral drugs tended to have the longest list of potential side effects, as did some newer medications for restless leg syndrome and Parkinson’s disease. Medications prescribed by psychiatrists and neurologists had the most complicated labels, and drugs used by dermatologists and ophthalmologists were the least complicated.
“We put a number on it so we can begin to make a real case to FDA, drugmakers, and other stakeholders to address this head on,” Duke says.
He and his colleagues are developing software to help filter, prioritize, and personalize relevant drug safety information. He says he envisions “a dynamic label that uses electronic medical records to pull in the information that is most relevant.”
Unless and until such changes are made, “the key thing is to ask your doctor about side effects because doctors are pretty good filters,” Duke says. “There are some things that most people will never, ever get yet patients are often afraid to take the medicines because of how scary the labels are."
Check With Your Doctor or Pharmacist
Drug companies are now required to do post-marketing studies of their drugs after they are approved, says Olveen Carrasquillo, MD, an associate professor and chief of general internal medicine at the University of Miami in Florida.
As a result, a lot more information is being reported about medications’ potential side effects.
Previously, these regulations were too lax and certain highly-prescribed drugs were found to cause serious side effects after approval, but the pendulum may have swung too far in the other direction, Carrasquillo says.
“I get patients who will call me and say, 'This drug can cause 100 things. Why did you prescribe that to me?’” Carrasquillo says. “I explain that the companies are required to report this information, and I discuss the major side effects that they have to worry about."
Some people may just decide to stop taking a potentially life-saving drug because of a tiny risk of a rare side effect. “If you have a concern, don’t stop on your own, communicate with your doctor,” Carrasquillo says.
“Every drug has a side effect and every treatment has an upside and downside,” says Diane C. Pinakiewicz, the president of the National Patient Safety Foundation President in Boston.
She says the problem is that this information is not disseminated in a “patient-friendly” manner. “The intent was pure, but it is just so consumer-unfriendly,” Pinakiewicz says. “Some package inserts are so long that you could wear them like a shawl."
Her advice: Talk to your pharmacist. “Ask them to talk you through anything you are concerned about. … Always ask questions to get as much information as you can and have someone help you put risks into context, so you don’t jump to the wrong conclusion."