Is the FDA Sending Mixed Messages Regarding Hydrocodone Drugs?

Although the Food and Drug Administration recently announced it will recommend up-scheduling hydrocodone drugs from a Schedule III to a Schedule II drug due to its potential for abuse, the agency has just approved the first ever extended release hydrocodone drug, Zohydro™ ER. Hydrocodone is a semi-synthetic opioid derived from codeine.

As we reported in October of 2012, the Food and Drug Administration released a briefing on hydrocodone in anticipation of a 2012 Drug Safety and Risk Management (DSaRM) Advisory Committee meeting which devoted considerable time to the topic of hydrocodone abuse and risks. Over the past few years the DEA has repeatedly petitioned the FDA to reschedule these drugs. On October 24, 2013, the FDA announced its plan to work to reclassify the drugs:

…However, in recent years, the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States. While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse…By early December, FDA plans to submit our formal recommendation package to HHS to reclassify hydrocodone combination products into Schedule II. We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products.

The day after announcing the plan to reclassify the drugs, the agency announced its approval of Zohydro ER, an extended release hydrocodone product without acetaminophen, noting:

Zohydro ER is in the class of extended-release/long-acting (ER/LA) opioid analgesics. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief.

The Milwaukee Sentinel reported that the doses of the drug will contain five to ten times more narcotics than more traditional hydrocodone products such as Vicodin®, which combines hydrocodone and acetaminophen, an over the counter pain reliever. The drug will be available in six dosage levels. The drug’s warning label contains numerous warnings, including that of the risk of abuse and dependency.  Many news agencies have noted that agency staff previously recommended against Zohydro ER, according to the Milwaukee Sentinel:

A November 2012 memo from the FDA’s own staff warns that the drug will be abused more than traditional hydrocodone products. The memo compares what likely will occur with Zohydro to what happened with extended-release, oxycodone-containing opioids.

Critics of Zohydro ER note that if chewed or crushed the extended release coating is rendered useless, allowing for a large dose of narcotics at one time. Because Zohydro ER is not mixed with an over the counter pain reliever, which might mitigate some recreational users concerns about ingesting it in a crushed form.

In July 0f 2012, the FDA released a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioid medications. The REMS was in response to a variety of factors including the Centers for Disease Control and Prevention (CDC) statistics that show that 15,597 Americans died from overdoses involving opioids in 2009, an almost four-fold increase from 1999. The makers of Zohydro ER will be required to implement a REMS for the drug, per the FDA. Despite the implementation of REMS,  local communities are working hard to combat the issue of rampant opioid abuse, as reported here New York City made headlines in early 2013 when it announced a city policy that emergency departments: (1) will not prescribe long-acting opioid painkillers; (2) may prescribe no more than a three-day supply of opioids; and (3) will not refill lost, stolen or destroyed prescriptions.

For previous Wolters Kluwer articles on opioids, please click here.