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More people are reporting drug side effects than ever. Experts say that could save lives.


More than 1 million reports of side effects were filed with the Food and Drug Administration in 2015. That's five times more than in 2004, the Milwaukee Journal Sentinel reports

Experts say that's good news and will go far in keeping Americans safer. 

The system by which side effects are reported to the FDA is largely voluntary. Only drug companies are required to report problems, not doctors or patients. And since many people don't report side effects, some fear medicines could be more dangerous than they let on.

Sheer numbers have some scientific weight. If 500 people report a problem, it is unlikely they are all wrong.
Thomas Moore, ISMP

Why this matters

Some experts, like Thomas Moore of the Institute for Safe Medication Practices, argue there's strength in numbers. High-profile medications and devices like the Zecuity anti-migraine armband were shut down after dangerous side effects caught attention.

And reporting side effects can kick off the opposite of a vicious cycle: a "virtuous circle," in the words of Advera Health's Brian Overstreet. He argues the more reports the system gets, the more likely it is to get media attention, which means it's more likely to draw more voluntary reports, and the cycle continues.

So far, it's working. In 2004, 45,000 side effect reports, roughly 20 percent of the total, came from consumers. As of 2015, the last year with finalized data, consumers are the source of a majority of reports.

The FDA's take

The FDA, however, warns that using side effect reports for research can be dangerous. There's no scientific vetting process to make sure the side effect was actually caused by the drug. 

Yale University School of Medicine associate professor Joseph Ross said he has tried to use the database before, but it was "very, very clumsy." It lists the number of reports, but that number is often useless without knowing how many people use the drug. 

It reflects that the FDA has allowed drugs to come to market without adequately ensuring safety.
Michael Carome

Seven of the most-reported drugs, according to the Journal Sentinel, carry "black box warnings," the FDA's label for the most serious potential side effects. Michael Carome of the Public Citizen's Health Research Group said he was "concerned."

Some of the most-reported drugs:

  • Vioxx -  painkiller pulled from shelves over fears it could cause heart attacks
  • Avandia - a diabetes drug initially pulled due to heart attack fears but reinstated despite ties to 78,000 side effects and 6,500 deaths
  • Humira - an autoimmune drug linked to 4,200 deaths since 2013, with 2.4 million prescriptions in 2015
  • Revlimd - cancer drug linked to more than 10,000 deaths and 69,000 overall reports 
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