PAIN PATCH APPROVAL SHOULD WAIT FOR OVERLAY STUDY RESULTS
Mylan Technologies wants the FDA to hold off on approving pain patches until studies show that overlays to keep the devices stuck to the skin are safe.
Manufacturers and those seeking premarket approval for the devices need to conduct studies on how patch overlays for Duragesic fentanyl transdermal patches could affect the safety of drug delivery, and the FDA needs to require firms to update device labeling to address the issue, John O'Donnell, Mylan's chief scientific officer, said in recent letters to the agency.
In a citizen petition he filed with the agency March 16, O'Donnell cited a July 15, 2005, FDA alert indicating the patches and their generic equivalents have problems sticking to the skin. This could compromise proper delivery of the drug into the bloodstream and "may cause death from overdose," the agency said.
The Duragesic labeling states that if the patch is cut or damaged, "controlled drug delivery will not be possible, which can lead to the rapid release and absorption of a potentially fatal dose of fentanyl," O'Donnell pointed out.
O'Donnell's concerns center on whether overlays used to keep the patch from falling off could lead to breaches in the patch or alter the levels of fentanyl absorbed by the body.