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Anti-Seizure Drug Targeted for Controlled Substance Restrictions

Feb. 9, 2022, 5:01 AM

The popular pain and seizure drug gabapentin is under fire for its alleged role in America’s overdose crisis, with an influential consumer advocacy group urging the government to classify the prescription medication a controlled substance.

Almatica Pharma’s Gralise and Pfizer‘s Neorontin are among the brand-name drugs that would be under U.S. Drug Enforcement Administration watch should Public Citizen convince the government to categorize gabapentin and gabapentin enacarbil under Schedule V of the Controlled Substances Act.

Public Citizen is no stranger to calling on the government to classify prescription drugs as controlled substances. The group has petitioned for the DEA to mark the opioid tramadol up from a Schedule IV to the more closely-monitored Schedule II substance ranking.

Classifying gabapentin under Schedule V would require manufacturers, hospitals, distributors, and others on the drug supply chain to register with the DEA, keep records, and abide by other agency requirements.

The drug is used to treat certain types of epilepsy and nerve pain. The Centers for Disease Control and Prevention has previously recommended prescribing gabapentin to treat pain in place of opioids. In 2016, gabapentin was the most commonly prescribed drug in the U.S., with doctors doling out the drug for various types of pain, according to the New England Journal of Medicine.

Public Citizen says the drug is misused too much.

“The drugs have a marked potential for abuse with serious consequences that include psychological effects, physical dependence, seizures, suicide, and overdose death,” Public Citizen said in a Wednesday petition to the Food and Drug Administration and DEA.

The petition comes amid efforts to slow America’s rising overdose numbers, which have only gotten worse during the Covid-19 pandemic. CDC data show over 101,000 overdose deaths for the year up to June 2021.

Timely Petition

Public Citizen’s petition comes in the wake of a renewed look at opioid use in the U.S. during the pandemic. Lawmakers have made opioids a key component in their efforts to address mental health and in considering the nomination of Robert Califf to head the FDA. Some Democrats worry that Califf was slow to address the crisis when he led the FDA in the Obama administration.

Meanwhile, prosecutors and others have gone after pharmacies, companies, and executive leaders for enabling the opioid epidemic. A former drug distributor CEO was recently convicted of conspiring to sell opioids to businesses that diverted the medications to street dealers.

Gabapentin, according to Public Citizen, has been shown to increase risk of overdose deaths when used alongside opioids. Public Citizen also points to gabapentin’s similarity to pregabalin—a Schedule V drug for treating seizure and neuropathic pain—in making its case.

“Gabapentin has been dangerously unscheduled as a controlled substance for too long despite increasing evidence of abuse and misuse and despite its strong similarity to pregabalin, which has been a Schedule V drug for more than 15 years,” Michael Abrams, senior health researcher for Public Citizen’s Health Research Group, said in a statement.

Some states have taken their own actions to restrict gabapentin distribution. The Journal of the American Pharmacies Association said that as of 2020, seven states had classified gabapentin a controlled substance.

Following a petition, the DEA can investigate a drug to see whether it should be federally categorized a controlled substance, considering things like potential for abuse and risks to public health. Schedule V drugs include cough medicines with codeines.

To contact the reporter on this story: Ian Lopez in Washington at ilopez@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com

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