1. Aschenbrenner, Diane S. MS, RN


* The Food and Drug Administration is recommending that drugs containing the narcotic hydrocodone be reclassified as schedule II controlled substances, indicating that they carry a higher potential for abuse than was previously believed.


* The agency also recently approved an extended-release form of hydrocodone, Zohydro ER, as a single entity for the treatment of severe and chronic pain when other treatment options have been inadequate.


* Like other extended-release and long-acting narcotics, Zohydro ER's labeling will carry strong warnings of its potential for abuse or overdose and its possible adverse effects.



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Hydrocodone is a narcotic similar to codeine. Available in combination with other drugs, such as acetaminophen, aspirin, phenylephrine, and guaifenesin, hydrocodone has been classified as a schedule III substance. Concerns have been raised that hydrocodone carries a higher risk of abuse than was initially believed. For several years the Food and Drug Administration (FDA) has been evaluating the literature regarding the abuse potential of hydrocodone, as well as public comments on the subject from patients, health care providers, outside experts, and other government entities. The agency has now recommended that hydrocodone combination products be reclassified as schedule II drugs in recognition of the greater risk of abuse. (Schedule II drugs are described as having a "high potential for abuse," which can "lead to severe psychological or physical dependence"; in contrast, with schedule III drugs the "potential for abuse is less than [with] schedule I or II [drugs]; abuse may lead to moderate or low physical dependence or high psychological dependence.") It's expected that the Department of Health and Human Services and the Drug Enforcement Administration will agree with this recommendation.


Interestingly, the FDA also recently approved a new extended-release, long-acting hydrocodone formulation for use in the management of pain that requires long-term, daily, around-the-clock treatment and for which other treatments are inadequate. This is the first time hydrocodone has been approved as a single entity rather than in combination with another product. Zohydro ER has been approved as a schedule II substance. Abuse of prescription drugs is a growing problem in the United States, and like other extended-release and long-acting narcotics, Zohydro ER carries a risk of abuse. Such drugs also pose a risk of overdose if they're abused. The FDA recently strengthened the warnings concerning all extended-release and long-acting narcotics (see Drug Watch, January); the labeling of Zohydro ER carries the same strong warning about these safety risks and adverse effects.


Nurses prescribing or caring for patients prescribed Zohydro ER should instruct them to swallow the medication whole and not to crush, chew, or dissolve it, which would alter its extended-release action, making more drug available initially and increasing the risk of respiratory depression. Patients should also understand that they shouldn't increase the dose on their own because overdose is possible. If their pain isn't controlled, they should contact the prescriber. Because the drug must be tapered before discontinuation, nurses should also instruct patients not to discontinue Zohydro ER suddenly. Additional education reflects that provided with all other narcotics, including the risks of orthostatic hypotension and constipation, and an impaired ability to drive or operate heavy machinery.


For more on the proposed reclassification of hydrocodone, go to For complete FDA prescribing information for Zohydro ER, go to