As America’s newest prescription painkiller Zohydro prepares to hit the markets in March, critics have embarked in one final effort to halt its release.
Just earlier this week, more than 40 prominent health care, consumer and addiction treatment groups—including CASAColumbia, Blue Cross Blue Shield, and Hazelden—signed a letter to the FDA to repeal Zohydro.
“In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the petition reads. “We urge you to exercise your authority and responsibility to protect the public’s health by keeping Zohydro off the market.”
This petition is one of many, and the group represents the opinion of thousands of others.
What is Zohydro and why do people want to keep Zohydro off the market?
Manufactured by Zogenix, a pharmaceutical company based in San Diego, Zohydro is a new painkiller that contains pure opioid hydrocodone, the active ingredient in Vicodin.
But unlike Vicodin, which is a combo of a large dose of acetaminophen with just a few milligrams of hydrocodone, Zohydro can contain up to 50 milligrams of pure hydrocodone. In fact, one capsule of Zohydro contains enough opioid to kill a child.
While Zohydro offers an effective alternative for pain control, its sheer potency also increases the likelihood of abuse and addiction.
According to the CDC, the overprescribing of opioids was the main cause of the nation’s opioid epidemic, and the Substance Abuse and Mental Health Services Administration (SAMHSA) reported a 430% increase of treatment admissions for abuse of prescription pain relievers from 1999 to 2009.
Like the popular painkiller Oxycontin, Zohydro can be easily crushed and thus easily abused. Although Zogenix is working on a crush-resistant formula, long-term use of this drug can still lead to tolerance and dependence—even when patients use it as prescribed for medical reasons.
So when the FDA approved Zohydro back in October despite an almost unanimous warning against the drug by the FDA advisory committee, addiction experts launched into a passionate campaign against Zohydro.
Are there safety measures in place to prevent Zohydro from being abused?
Yes. Zogenix and the FDA have set up several barriers to minimize abuse.
Crush-Resistant Formula. As aforementioned, Zogenix is working on a crush-resistant formula of Zohydro, which should be available in the next three years.
External Safety Board. Zogenix has also implemented an External Safety Board, a panel of professionals who will evaluate the prescription and use of Zohydro.
According to the Zogenix press release, the board “will allow external, highly experienced specialists, to provide valuable insight and advice about the impact of introducing this new pain treatment to the community and, if needed, to recommend specific actions needed to ensure that the risk of abuse, misuse and diversion is minimized.”
Decreased risk of liver damage. Because long-term use of acetaminophen can cause liver damage, Zohydro supporters argue that an acetaminophen-free pain medication can reduce the risk of liver failure and provide another therapeutic option of pain control.
Limited prescription. As a Schedule II drug, Zohydro will be strictly monitored, and prescription will be limited for patients whose pain is not relieved by alternative treatment options.
Do the risks outweigh the benefits?
Still, critics still argue that the consequences of bringing another potent opioid drug to the market outweigh the benefit. Although it may be too late now to prevent Zohydro’s release, critics will continue fight to keep similar drugs off the market in the future.