Health Alert
WARNING ABOUT ZOHYDRO ER HYDRODOCONE TABLETS

The Delaware Division of Public Health (DPH) is issuing this health alert to provide the healthcare community with Zohydro ER caution information.

Summary

Zohydro ER was recently released into the US market and has generated significant public health concerns including a potential heightened risk of accidental overdose. Several states (including Delaware) are considering or have already put restrictions on its use.

Background

The medication is a single entity hydrocodone tablet (not combined with an analgesic such as acetaminophen) that is available in six different strengths from 10 mg to 50 mg and is to be prescribed to be used no more than every 12 hours. Zohydro is only formulated in an extended released formulation and has no immediate release form and thus is not approved for “as needed” pain relief.

Several properties of the medication raise serious concerns. According to the FDA, although it approved the medication, the drug has a greater risk of overdose and death than other extended-release opioids. The medication is not tamper-resistant so unlike other extended release opioids, if the tablet is chewed or crushed, there could be an immediate and unpredictable release of the opiate into the patient’s system. In addition, the drug does not have an abuse deterrent formulation (for example, antagonist combinations, specialized delivery system or aversion formulation if the drug is manipulated prior to ingestion).

Recommendations

• Avoid prescribing Zohydro to any patient if another alternative is available.
• Do not prescribe to the elderly and debilitated patients and those with respiratory depression or hypercarbia.
• If a patient is identified with mental health or addiction issues, refer for appropriate treatment as soon as possible.

Additional Information

Visit the FDA Risk and Evaluation (REMS) website of up-to-date information on specific opiate medication-risks: http://www.fda.gov/drugs/drugsafety/informationbydrugclass/ucm163647.htm

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