In the throes of an opioid epidemic, the US Food and Drug Administration (FDA) decided in August 2015 to expand the indications for OxyContin, an extended-release form of the narcotic oxycodone, to children aged 11 years and older. The decision sparked outrage in those who fear the move might fuel increasing opioid addiction among young Americans.
Although drug manufacturers are required to include new safety information for pregnant and lactating women on their labels, much more clinical data is needed to determine whether products are safe for that population, according to professors and clinicians.
Should generic drug makers be required to update their drug labels about safety concerns before FDA reviews the change? Should this be done even if the information differs from the brand name drug labels temporarily?
According to a rule proposed by FDA in the Federal Register (December 18, 2014), healthcare providers would receive prescription drug and biologics product labeling information via an electronic system, thus replacing the use of paper to provide such information on the safety and effectiveness of human prescription drugs.
At its late September meeting, the Pediatric Advisory Committee (PAC) to the US Food and Drug Administration (FDA) said it’s time to remind healthcare professionals that Singulair (montelukast) may have adverse effects on mental and behavioral functions.
Despite some key pieces of federal legislation passed in recent years, most drugs—about 93%—are still not studied in neonates. Of those drugs that researchers have studied in this vulnerable population and that bear labels reflecting the changes in pediatric prescribing information, only about half (54%) are used in the neonatal intensive care unit (NICU).