FDA drug approval raises abuse concerns

The Food and Drug Administration is having serious conversations about hydrocodone that could drastically change the future of one of medicine’s most common painkillers.

The biggest surprise came from the FDA’s approval of a new opioid called Zohydro. The drug’s main–and only– ingredient is hydrocodone, an opioid used in drugs like Vicodin to combat serious pain.

According to Zogenix, the manufacturer of Zohydro, the drug is designed for patients with pain that requires “daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.” However, the drug’s potency has raised concern among health officials who specialize in abuse prevention.

“Given that Zohydro is pure hydrocodone, it is a very powerful opioid painkiller and the potential for abusing this drug is high,” Rebecca Aronson said. Aronson is the alcohol and substance abuse prevention specialist at DePaul.

Aronson is one of many officials who find the FDA’s decision puzzling at best. The agency’s advising panel rejected the drug back in 2012, she said, and she’s dismayed by the change of heart. Moreover, she doesn’t believe the FDA did enough to make it resistant to abuse.

“The problem with Zohydro isn’t necessarily its classification…but the fact that the FDA did not require it to be more resistant to abuse,” Aronson said. “OxyContin, for example, has been reformulated so that pills can’t be easily crushed, broken, dissolved or injected. Holding Zohydro to the same standard could help curb the numbers of people who potentially would abuse this medication.”

“This means that people can still crush up Zohydro and get an instant, powerful high from it,” she added.

However, not everyone views Zohydro as a threat to the medical community. Matthew Sorenson, an associate nursing professor at DePaul, believes a pure form of hydrocodone might actually be a healthier alternative for those seeking pain relief. Hydrocodone is usually mixed with Tylenol, he said, which is known for causing serious liver damage. Sorenson added that Tylenol has caused the most accidental overdoses in the United States.

In addition, Sorenson said the lack of Tylenol would provide more effective pain control. A pure form of the drug makes the relief last longer.

“It’s another way of trying to deal with some of those pain issues,” he said.

While he understands the potential for abuse, Sorenson believes some people underestimate how necessary those drugs are for people with pain concerns. He said patients with chronic pain are painted in a negative light if they are required to take painkillers for an extended period of time.

Another FDA decision that’s stirring discussion is its proposal to reclassify hydrocodone as a Schedule II drug. Despite the abuse concerns surrounding Zohydro, this FDA proposal is the agency’s way of attempting to combat prescription drug abuse.

According to Aronson, making hydrocodone a Schedule II means doctors would only be able to give out 90-day prescriptions for hydrocodone, and patients must visit their physician for a refill. In addition, pharmacies could no longer accept prescriptions that were faxed or called in.

Aronson hailed the proposal, but Sorenson sees only trouble if the FDA follows through with it. He said people with chronic pain would be forced to see their physician on an almost constant basis, and some people don’t have the time or money to do that. Plus, he said, more people are starting to take advantage of medical resources now that the Affordable Care Act has kicked into gear.

“It’s going to make it really hard,” he said.

Despite that, Aronson believes prescription drug use is an epidemic that needs to be controlled. She cited the Center for Disease Control and claimed deaths from opioids have exceeded those from other illegal drugs. And at DePaul, 6.3 percent of students reported using prescription drugs illegally in a 2013 survey conducted by the National College Health Association.

“Opioids are very highly addictive- just as addictive as heroin-and it’s very hard to recover from opioid addiction,” Aronson said. “Just because a drug is prescribed from a doctor doesn’t mean it’s risk-free.”