Faster drug approval may lead to missing critical safety concerns

Over the last few years, consumers and pharmaceutical companies urged the Federal Drug Administration (FDA) to move faster through their regulatory process. One of the risks of accelerating this process, however, is that dangers of the drugs may be overlooked or missed.

In fact, a recent study of medications that were moved through the accelerated approval process resulted in a slightly higher incidence of drugs that require additional warnings or are withdrawn from use. Other research on this subject shows similar results.

The new study on drugs receiving FDA approval shows that nearly one-third of them later needed warnings about severe and in some cases, potentially fatal, side effects. These medications most often treat blood clots, depression and other mental illnesses, infections and arthritis. The study’s researchers found a broad range of safety concerns that include:

  • Liver damage
  • Cancer
  • Reactions on the skin
  • Death

Some of the medications needed black-box warnings while manufacturers pulled others from the market.

A few of the medications that received additional warnings but are still on the market include:

  • Abilify
  • Humira
  • Pradaxa

Safety resources for consumers

Wondering if the medications you or your family members take are safe? You can look them up on the FDA’s website or talk to your doctor or pharmacist.

Dangerous and defective medications hurt people every day. If you or a loved one suffers a serious or fatal injury from a medication, you should speak with a lawyer. It may be possible to seek compensation from the negligent manufacturer, but you will need help.

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