32% of new drugs flagged for safety events in the USA

Research published in the Journal of the American Medical Association (JAMA) has found that a third of drugs approved by US regulators are subsequently flagged for a safety event.

While postmarket safety events vary in severity and significance, they are important as they can change how drugs are used in clinical practice.

The researchers, led by Yale professor Joseph Ross, looked at 222 novel therapeutics approved by the US Food and Drug Administration between 2001 through 2010, finding that 71 were affected by an event such as withdrawal, the addition of a boxed warning, or a safety communication.