Zohydro ER has been heavily criticized for lacking safeguards that would diminish abuse potential. In its current form, Zohydro ER can be easily crushed, snorted, or injected. Zohydro ER is only currently available in capsule form; hence, it can easily be opened, making pure hydrocodone available. Critics of the drug’s approval suggest that it should have included an “abuse-deterrent” formulation, such as additives like naloxone or niacin that cause unwanted side effects when the drug is snorted or injected but are tolerable when taken orally as prescribed. Zohydro ER does not contain any ingredients that would safeguard against abuse. In the companies’ defense, these additives seem logical but have not been a proven deterrent to abuse.

Purdue Pharma, the maker of Oxycontin, has completed testing of an abuse-resistant version of the painkiller hydrocodone. Purdue Pharma says it plans to submit its extended-release hydrocodone drug to the FDA in late 2014. It will be interesting to see if clinicians adopt this potentially safer formulation.⁴

What’s a Physician to Do?

As a practicing toxicologist, I err on the side of caution with adopting newer potent opiates. For example, this drug is potentially so potent that an opiate-naive patient could die of an overdose from just two to four pills and a toddler from one capsule. Following overdose or accidental ingestion, it is prudent for patients to undergo an extended observation period. In my opinion, such patients should be observed at least 12 hours, assuming no naloxone was used, until future data are collected.

In summary, the FDA approved Zohydro ER for the management of pain severe enough to require daily, around-the-clock long-term opioid treatment and for which alternative treatment options are inadequate. At least initially, if you prescribe this drug, be aware of this indication. Be aware that the peak may not occur for six hours in “normal” patients in “ideal” circumstances. Be aware that Zohydro ER is metabolized via P450 interactions P450 3A4, and drugs such as macrolides or azole antifungals that inhibit this cytochrome may increase hydrocodone levels. Be aware that ethanol and other CNS depressants potentiate the effect. Be aware that clearance is altered, namely decreased in patients with hepatic and renal disease (not further identified). An FDA-approved patient medication guide, which is available with the product information and can be accessed at www.fda.gov/downloads/Drugs/DrugSafety/UCM374009.pdf, must be dispensed with this medication. Currently, it is approved as a Schedule II drug and can only be dispensed through a physician’s written prescription, and no refills are allowed. There are also stringent recordkeeping, reporting, and physical security requirements for Schedule II controlled substances. Considering the risk-benefit ratio, is this too much to be aware of for one drug?