The release of a new pain relief medication has stirred up fresh concerns about its potential for abuse, especially given the epidemic of overdose deaths linked to existing pain drugs. The new drug, released under the brand name Zohydro ER (hydrocodone bitartrate), is a high-dose extended-release hydrocodone intended for treating chronic pain requiring round-the-clock care. Designed to be used when other pain medications have failed, Zohydro ER is a longer-acting version of existing hydrocodone medications which are already being widely misused, and even sold as street drugs due to their popularity.
According to Center of Disease Control statistics, there have been more than 38,000 overdose deaths linked to painkillers in 2010 alone. Believed to be responsible for at least 420,000 emergency room visits each year in the United States, the number of narcotic deaths associated with fast-acting hydrocodone and oxycodone medications likely exceeds the deaths caused by heroin and cocaine combined.
State regulatory bodies and drug advocacy groups were incredulous when the Food and Drug Administration approved Zohydro for pain patients last year despite intense lobbying. Despite attempts at banning Zohydro in Massachusetts, the manufacturer, Zogenix, successfully overturned the ban in a US District Court. Despite the victory, other states have moved to establish similar ban and state officials have petitioned the FDA to reconsider the approval.
While Zogenix insists that the medication fulfils all the FDA requirements for approval, critics point out that Zohyrdo will be available in capsule form making it easy to be crushed into doses that can be injected or snorted. While other brands of painkiller medication are sold following FDA draft guidance on abuse-resistant formulations, nothing equivalent will be available for Zohydro will be available in the forseeable future. As an alternative, Zogenix is offering security caps on the medication bottles as well as strongboxes to deter theft.
In defending the decision to approve Zohydro for general use, FDA officials state that the medical needs of the 100 million Americans suffering from chronic pain means that more treatment options are necessary. “To say to people with chronic pain who are taking opiates around the clock that we shouldn’t offer them an extended-release option is unnecessarily penalizing the patient,” said Dr. Janet Woodcock of the FDA's Center for Drug Evaluation and Research in an interview with the New York Times. "“We need to balance the medical needs of people in severe pain with the risks of these medications, including the risk of abuse and addiction.”
To monitor potential misuse of Zohydro, the FDA has ordered post-marketing surveys and eliminated automatic refills. The language on warning labels has also been strengthened but critics warn that the new measures may not be enough to prevent further overdose deaths linked to the new medication. Opponents of Zohydro have organized protests across the United States with rallies in Washington, D.C. and Boston as well as the formation of lobby groups to pressure the FDA to reverse its decision. Canadian groups are also pressuring the Minister of Health to block the sale of