black-box warnings

A new study in JAMA suggests that nearly one-in-three drugs approved by the FDA between 2001 and 2010 had post-market safety issues, which caused safety communications to physicians and consumers, "black-box" warnings on labels, and drug withdrawals. It is not clear how many patients may have died or otherwise harmed by these issues...Lead author Joseph Ross, M.D., noted: "No drug is completely safe, and during premarket evaluation, we are not going to pick up all the safety signals," and urged "that we have a strong system in place to continually evaluate drugs and to communicate new safety concerns quickly and effectively."

Read More »