Study: Restricted fentanyl given to ‘alarming’ number of patients

Researchers found that the FDA and opioid manufacturers failed to monitor the restricted use of a powerful type of fentanyl even after problems were discovered


By EMS1 Staff

BALTIMORE — A recent study found that patients were unnecessarily given a highly potent form of fentanyl at an “alarming” rate.

According to the study, conducted by Johns Hopkins Bloomberg School of Public Health researchers, the US FDA and opioid manufacturers did not adequately monitor the restricted use of Transmucosal Immediate-Release Fentanyl, which is 100 times more powerful than morphine.

Researchers found that the FDA and opioid manufacturers failed to monitor the restricted use of a powerful type of fentanyl even after problems were discovered. (Photo/FDA)
Researchers found that the FDA and opioid manufacturers failed to monitor the restricted use of a powerful type of fentanyl even after problems were discovered. (Photo/FDA)

The study said the FDA’s Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy, a program that was launched to prevent inappropriate prescriptions, failed to make any substantive changes, even after problems were discovered by officials.  

"We found alarming use of these products in patients who never should have received them," said G. Caleb Alexander, senior author G. Caleb Alexander said. "The prescribing of this medicine was supposed to be closely monitored and contained but was not. What we found was that several years after the program was started, there were alarming deficiencies identified, and yet little was done by the FDA and drug manufacturers to effectively address these problems."

Researchers looked at 4,877 pages of reports from 2012-2017 about TIRFs, which are meant for cancer patients only who are already on around-the-clock opioid regimens.

The fentanyl is delivered through lozenges, sprays and tablets, and goes into the bloodstream within seconds. Alexander said it is "one of the most highly potent and rapidly acting opioids on the market.”

The study found that thousands of patients, more than half of those who used the drug, should never have been prescribed it.

"These drugs are dangerous enough, they should never be used in patients who aren't already on around-the-clock opioids," Alexander said.

Researchers found in the documents that the FDA said the program was "not meeting its overall goal or most of the objectives."

Opioid Police Research Collaborative co-director Andrew Kolodny told CNN the research highlights a “total failure by the FDA to protect the public.”

"Despite overwhelming evidence of problems with TIRFs, the FDA has done nothing to change and is continuing the status quo,” he said. "The majority of the TIRF patients don't have cancer and aren't tolerant of opioids. This is very disturbing.”

FDA officials said they are concerned as well about whether or not the program is “working as intended.”

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