Posted by Michael Wonder on 30 Sep 2020
Study identifies shortcomings in FDA evaluations for new opioid drug approvals over two decades
29 September 2020 - Systematic assessment of safety-related outcomes has been lacking, researchers find.
Approvals of prescription opioids by the U.S. FDA over more than two decades have been based on evaluations in narrowly defined patient groups for which certain safety related outcomes have been rarely systematically assessed, according to a new analysis from researchers at the Johns Hopkins Bloomberg School of Public Health.
For their study, the researchers examined clinical trial data provided by manufacturers to the FDA for all new opioid applications approved by the agency between 1997 to 2018, a total of 48 applications. The researchers found that for products labeled for the treatment of chronic pain, no trials lasted for longer than three months. These trials often excluded patients who could not tolerate the drugs and failed to systematically assess some important and well known opioid-related adverse events.
