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Study Suggests Post-Approval Safety Problems Come up for Many Drugs

A drug receiving approval from the U.S. Food and Drug Administration doesn’t mean that no new safety issues will come up regarding the drug after its release. In fact, a recent study indicates that post-release safety problems are actually pretty common among FDA-approved medications.

The study looked at 222 prescription drugs that received FDA approval. These drugs were approved between 2001 and 2010. They make up all the prescription drugs approved over that period.

The FDA conducts post-release monitoring of the drugs it approves. The study looked at the monitoring of the above-mentioned prescription drugs to see which ones had safety problems that came up post-release.

The study found that 71 of the drugs had such issues arise. The problems covered a range of side effects and complications, some of which were even life-threatening. Biologic drugs and psychiatric drugs and were the drugs that most commonly saw such safety issues.

According to the study’s lead author, one thing this study points to is the effectiveness of the FDA’s efforts to monitor drugs for safety problems after they are approved. However, the study’s results also appear to raise questions as to whether drugs are adequately tested for safety problems before being approved. Do you think any changes should be made to the FDA’s processes for approving medications?

Safety problems that come up after a drug has been approved can have serious impacts on a person’s life. Exposure to major side effects or complications from a dangerous drug can leave a person with significant health problems. Such problems can have major costs for a person, financial and otherwise. For some individuals, pharmaceutical litigation may provide a route to get compensation for such costs. Individuals harmed by dangerous drugs can go to lawyers skilled in such litigation for guidance regarding their legal options.

Source: AP, “Study: Side effects emerge after approval for many US drugs,” Lindsey Tanner, May 9, 2017