FDA Takes Action to Prevent Fentanyl Harm

Washington, DCThe US Food and Drug Administration (FDA) has taken action to prevent problems with fentanyl patches and other opioid drugs. The agency, in cooperation with the White House, has announced a plan to combat the prescription drug abuse crisis, which has put patients at serious risk of side effects from the fentanyl Duragesic patch and other opioid drug side effects. The move, which affects the Duragesic patch, requires makers of opioid pain relievers, including fentanyl patches, to come up with a Risk Evaluation and Mitigation Strategy (REMS).

That strategy affects all extended-release and long-acting opioid medications, which are used to treat moderate and severe pain. Included in that are Duragesic pain patches (Duragesic is known generically as fentanyl), OxyContin and Avinza. According to the FDA, these drugs are often misprescribed, misused and abused, putting patients at risk of overdose and, in some cases, death.

The new REMS focuses on educating doctors about pain management and patient selection to ensure the drugs are only prescribed to patients who meet criteria for opioid treatment. Furthermore, companies that manufacture the pain relievers are being asked to include a medication guide that explains safe use of the drugs. Manufacturers must propose their REMS plans within 120 days of the FDA's April 19 announcement.

In making its announcement, the FDA noted that more than 33 million Americans aged 12 and older misused opioid medications in 2007.

A Risk Evaluation and Mitigation Strategy is a plan developed and implemented by a drug company—at the request of the FDA—to manage serious risks associated with a medication. The strategy is used to ensure that a drug is used properly and that the drug's benefits still outweigh the risks.

The FDA determined that a REMS was required for long-acting and extended-release opioid medications because they were being prescribed for patients who did not need the strength of the opioid drugs and because some patients use them improperly, either on purpose or accidentally. The problem with long-acting or extended-release opioids is that they often contain a much higher amount of opioid than the immediate release medications and can take hours to be removed from the body. This can increase the risk of overdose and, potentially, death.

Duragesic pain patches are different from other opioids in that they are delivered via a transdermal pain patch—a patch that is placed on the skin. Fentanyl pain patches have been recalled numerous times because of issues with manufacturing that have resulted in patients receiving much more of the active ingredient (fentanyl) at once than intended. Fentanyl patches are recommended only for patients who have chronic, debilitating pain that is not controlled with other painkillers and who have a tolerance for opioid medications. Lawsuits against the makers of fentanyl patches allege that improper manufacturing resulted in the accidental deaths of some fentanyl patients.