Whether taking an over-the-counter (OTC) drug or one prescribed by a doctor, patients generally assume that medications are safe. How the drug got its approval by the Food and Drug Administration (FDA), which regulates the safety of medicines sold in the United States, is not usually questioned.
The agency, which effectively oversees $2.4 trillion of the U.S. economy, issues warning letters about the safety of drugs that are already on the market. These warnings are at their lowest level since 2008.
Still, a recent report shows that about a third of the medications permitted on the market by the agency between 2001 and 2010 had safety concerns issued later on. These included three withdrawals, 61 boxed warnings — which are meant to call attention to serious risks associated with the drugs — and 59 safety communications. Medications prescribed to treat mental illness and those subjected to an accelerated approval process had more problems.
Dangerous drugs can slip past the FDA and find their way to consumers. Regulations, guidelines and drug laws change as new research emerges, showing negative effects that were unknown before.
Some of the drugs on our list of recalls were approved after 1988 when the government allowed a “fast track” approval process to make medications aimed at treating serious and life-threatening conditions available sooner.
To identify 18 of the worst drug recalls in history, 24/7 Wall St. reviewed scores of reports and safety alerts issued by the FDA, as well as numerous news articles about medications that have been pulled off the market.