Reporting of prescription drug side effects is on the rise

The U.S. Food and Drug Administration received more than 1 million reports of drug side effects in 2015, up nearly 500 percent since 2004, according to an analysis by the Milwaukee Journal Sentinel and MedPage Today.

While 2016 numbers are not yet final, they are also expected to reflect an all-time high. Reported side effects could be as benign as flatulence or as serious as death.

What’s going on?

Experts aren’t sure whether more patients are being harmed or a vigilance in reporting — or both – are behind the numbers.

The FDA’s adverse events system is largely voluntary. Drug companies are required to report problems, but doctors and patients are not.

However, the growing number of reports has drawn more attention. The FDA has relied on reports to increase its scrutiny of certain drugs, including a skin patch created to combat migraines that caused many to experience severe blisters, burns and skin lesions. The product was eventually taken off the market.

Of the 10 most reported drugs, seven have “black box” warnings, the top alert for potential life-threatening side effects, the newspaper’s investigation found. Drugs that treat autoimmune disorders such as psoriasis, rheumatoid arthritis and Crohn’s disease generated a large volume of reports. Because these drugs suppress the immune system, there is an increased risk of serious or even deadly infections.

It’s always a good idea to tell your doctor if you think your symptoms may be tied to a prescription drug. Patients can also report side effects themselves via the FDA’s MedWatch website.

Do you have an experience with medication side effects? Share your story with Voices for Affordable Health.