The FDA wants to make sure doctors don’t respond to the opioid epidemic by over-prescribing another class of addictive drugs—nerve pain drugs advertised on television.
Known as gabapentinoids, these drugs, like Pfizer’s Neurontin (gabapentin) and Lyrica (pregabalin), are approved for a variety of conditions, including postherpetic neuralgia, fibromyalgia, and neuropathic pain.
Gabapentinoids can be addictive and prescriptions are on the rise, Kent Runyon, chief strategy and compliance officer of Novus Medical Detox, a Florida-based drug and alcohol addiction treatment center, told me. In fact, gabapentin was the 10th most commonly prescribed medication in the U.S. in 2016, with 64 million prescriptions dispensed that year, up from 39 million in 2012, according to an August 2017 article published in the New England Journal of Medicine.
The Food and Drug Administration is investigating whether their abuse or misuse is also increasing and, if so, what should be done to address the problem, FDA Commissioner Scott Gottlieb said Feb. 15 at a workshop on opioids. Doctors told me potential actions on these drugs should include more education for prescribers on their abuse potential and possibly their categorization as controlled substances.
“It makes a lot of sense for the FDA to look into it,” Runyon said. Before the opioid epidemic, opioid prescriptions rose dramatically. “We’re seeing that same trend now with this medication,” and “that’s certainly a red flag,” he said.
One reason for the increase in prescriptions is that doctors are looking for alternatives to opioids, but “it’s a risk if those alternatives put another medication into people’s hands that can be abused, can be addictive, or can be misused by people who are already misusing other medications to get a better high,” Runyon told me.
“I think we need to do more with education around this medication” for physicians on its abuse potential, Runyon said. He also said it makes sense to consider making gabapentinoids a controlled substance. A controlled substance is a drug whose manufacture, possession, or use is regulated by the Drug Enforcement Administration.
But there’s a concern that making gabapentinoids controlled substances would put burdens on the patients who need them.
“Less than 2 percent of people who take a gabapentinoid abuse it” and “to make it a controlled substance would make the rest of the 98 percent of the patients taking this medication go through lots of burdens,” Jianguo Cheng, president-elect of the American Academy of Pain Medicine (AAPM), told me. They wouldn’t be able to get more than a certain amount of their medication, and they would be subject to other restrictions, he said. The AAPM, based in Chicago, represents physicians practicing in the field of pain medicine.
Cheng said there isn’t sufficient evidence to make gabapentinoids a controlled substance. Cheng also is a professor and physician at the Cleveland Clinic.
Read my full article here.
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