Safety fears over new drugs

Nearly one-third of drugs cleared by the Food and Drug Administration are later flagged for serious safety issues, reports the Los Angeles Times. In a review of 222 drugs approved by the FDA from 2001 to 2010, scientists found that 71 were later flagged for safety issues that resulted in a recall, a health risk alert, or a new box label warning about life-threatening health risks. On average, the problems emerged about four years after the drugs were approved. Most drugs are tested on fewer than 1,000 patients, who are studied over six months or less; side effects or complications are more likely to be discovered when a drug has hit the market and been used by a more diverse group of people over a longer period. “No drug is completely safe, and during premarket evaluation, we are not going to pick up all the safety signals,” says lead author Joseph Ross, an associate professor of medicine and public health at Yale University. The findings, he says, illustrate the need for a “strong system to continually evaluate drugs and to communicate new safety concerns quickly.

– ‘The Week’ App.
May 27th 2017