FDA knew about dangerous opioid misuse, but failed to intervene, documents show

Physicians have frequently prescribed a class of fentanyl drugs intended for cancer patients with high opioid tolerance to patients with back pain and migraines, which puts a new population of patients at risk for accidental opioid-related overdose and death, according to FDA records cited by The New York Times.

Here are eight things to know:

1. The class of opioids include quick-absorbing fentanyl sprays, tables and lozenges. All of these opioids contain a narcotic up to 50 times stronger than heroin and up to 100 times stronger than morphine.

2. In 2011, the FDA put together a distribution oversight program, attempting to curb inappropriate use of these medications. The FDA placed the drug companies that manufacture and sell the opioids in charge of enforcement. A handful of these companies face legal battles for promoting alternative uses for the opioids.

3. The New York Times cites about 5,000 pages of a report obtained by researchers at Baltimore-based Johns Hopkins Bloomberg School of Public Health via the Freedom of Information Act that prove the FDA had data highlighting widespread off-label use of the opioids.

4. FDA officials told The New York Times they reviewed evidence showing many patients without cancer received the opioids. However, the agency had difficulty measuring the potential harm to patients due to the fragmented nature of the data, gathered from prescriber surveys, insurance claims and industry reports.

5. The documents obtained by researchers contained a 2013 survey in which 40 percent of the physicians prescribing the class of opioids reported giving the drug to patients without cancer to treat chronic pain. Forty-two percent of pharmacists indicated in the survey that the fentanyl-based drugs were appropriate for those ailments.

6. Another survey conducted in February 2017, showed fentanyl-prescribing physicians and about 48 percent of patients believed the drugs were approved by the FDA to treat noncancer illnesses.

7. To address patient access concerns, an industry group representing a specific brand of opioids, removed certain language from the mandatory patient-prescriber agreement form to make it easier for physicians to prescribe opioids to patients without an opioid tolerance in 2013. The group created a form that required physicians to indicate they understood the meaning of opioid tolerance, rather than seeing if the patient was in fact opioid tolerant. The form also did not include a clause affirming the patient receiving the opioids was already getting round-the-clock opioid care.  

"It is not open for debate that the risk of these drugs among patients who lack tolerance is unacceptably high. It's quite clear-cut," said Caleb Alexander, MD, associate professor of epidemiology and co-director of the Center for Drug Safety and Effectiveness at Johns Hopkins.

8. Scott Gottlieb, commissioner of the FDA, said in an August 1 statement, "We're taking the issue of how we manage the safe use of these products to our advisory committee, to bring transparency to what we know about how well these post market safety programs are working and to get their advice on how we could strengthen these restrictions to better protect patients."

More articles on opioids: 

Children in these 3 states experience opioid-related parent loss, incarceration above the national average
Opioid prescriptions static since 2007 despite increased awareness of misuse
Poison control centers report jump in calls over exposure to unapproved drug with opioid-like high

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