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New Study Finds Almost One-Third of New Drugs Approved by USDA Found to Have Serious Side Effects

By Jack H. FarnbauchJune 28, 2017

According to a new Journal of the American Medical Association study, new drugs may be being pushed out too fast. Almost one-third of new drugs approved by U.S. regulators over a decade ended up (years later) with warnings about unexpected, sometimes life-threatening side effects or complications. Many of these drugs are ones you’ve heard of and are potentially using.

The researchers analyzed online FDA data on new drugs and the agency's later safety announcements. Problems surfaced, on average, approximately four years after FDA approval. Almost one-third of new drugs approved by U.S. regulators over a decade wound up with warnings about unexpected, sometimes life-threatening side effects or complications that were not known at the time the product was introduced into the market. 

The results covered all 222 prescription drugs approved by the U.S. Food and Drug Administration from 2001 through 2010. The researchers looked at potential problems that cropped up during routine monitoring once a medicine is on the market. Of the 222 drugs that were analyzed, 71 were flagged for serious side effects. The 71 flagged drugs included top-sellers for treating depression, arthritis, infections and blood clots. Safety issues included risks for serious skin reactions, liver damage, cancer and even death.

You can read the study here.