Fentanyl Pain Patches Get Renewed Warning
The Food and Drug Administration issued another warning for the Duragesic and other fentanyl-containing pain patches, which have been associated with hundreds of accidental deaths.
In the new warning, the agency said patients and doctors often fail to understand the special risks associated with fentanyl patches, including the risk of potentially fatal overdose.
Not Like a Pill
“It’s a unique problem with the patches because of…the way that the drug is delivered to the body and the way that it’s metabolized. It’s complicated by the patch formula,” said Dr. Bob Rappaport of the FDA.
The patches are designed to deliver a steady dose of fentanyl, an extremely potent painkiller, into the body over several days. However, the patches contain a much higher dose of fentanyl than individual pills, and heat may increase the rate at which the drug is released into the skin.
2005 FDA Warning
In 2005, the FDA issued an alert about the risks of accidental overdose associated with fentanyl patches, but safety advocates say the advisory was insufficient and some say the agency still hasn’t gone far enough.
“I think there is more that needs to be done, or else we’re just going to see this [warning] happen again another two years from now. The deaths are going to continue,” said Michael Cohen, president of the Institute for Safe Medication Practices.
A Dangerous Drug
Last year, a study cited more than 3,500 deaths possibly linked to fentanyl, in all its forms, between 1998 and 2005. According to lead author Thomas J. Moore, “the patch was by far the largest contributor.”
Fentanyl patches are sold by various pharmaceutical companies. Duragesic is the brand name of the first fentanyl pain patch introduced to the market in 1990. The patches are intended for treatment of severe chronic pain in cancer patients, but are sometimes used for off-label purposes.