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West Virginia’s Sen. Manchin asks FDA, DEA to consider rescheduling gabapentin


The Register-Herald

BECKELY, W.Va. — U.S. Sen. Joe Manchin, D-W.Va., is calling on the Food and Drug Administration and the Drug Enforcement Administration to consider rescheduling a type of medication connected to overdose deaths in West Virginia.

Sen. Joe Manchin, D-W.Va.

In a letter to FDA Commissioner Scott Gottlieb and Acting DEA Administrator Robert Patterson, Manchin asked the officials to consider rescheduling and requiring additional risk mitigation for gabapentin, a nerve-pain medication labeled as a “drug of concern” by the West Virginia Board of Pharmacy.

“While our focus is appropriately on the devastating impact of prescription opioids, there are other prescription drugs that are also contributing to this crisis,” Manchin wrote. “In fact, the West Virginia Board of Pharmacy recently designated the nerve-pain medication gabapentin as a ‘drug of concern’ after the number of overdose deaths related to the drug increased from 36 in 2012 to 106 in 2016.”

Gabapentin is currently listed as a Schedule V drug under the U.S. Controlled Substances Act, but officials in Kentucky and Ohio have also increased regulation on and surveillance of the drug.

In the letter, Senator Manchin asked the FDA and DEA heads to answer the following questions: Are the FDA and DEA currently investigating the rise in abuse of gabapentin and related overdose deaths?; Are the FDA and DEA considering rescheduling this drug given the larger public health impact and the potential for abuse when taken with other dangerous medications?; Is the FDA considering implementing new REMS for gabapentin to ensure that prescribers and patients are fully aware of the danger of this drug when taken with other medications, including opioids?

Manchin highlighted a recent study focused on gabapentin abuse. Many patients were using the drug in combination with opioids, benzodiazepines and others.

“Given the recent rise in overdose deaths associated with gabapentin and the studies funding increased abuse of this drug, I am urging the FDA and the DEA to consider rescheduling this drug and requiring additional risk mitigation measures including physician and patient education around the potential for abuse, addiction, and overdose deaths when this drug is prescribed and used with other dangerous medications, including opioids.”

Email: [email protected]; follow on Twitter @WendyHoldren

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