ID-10013611The FDA recently approved Zohydro ER, the first single-entity and extended release hydocodone product. The new drug has been approved only in severe, chronic pain which requires daily, around-the-clock treatment and for which alternative treatments are inadequate, due to the high risk of over-dosage and abuse.  Common side effects include constipation, nausea, drowsiness, fatigue, dry mouth, and vomiting. Post-marketing studies of this new schedule II drug will be conducted to further evaluate adverse effects as well as potential of abuse with long term use. This is the first medication that follows the updated labeling requirements for all ER/LA opioid analgesics announced by the FDA in September 2013. What are your thoughts/concerns about this new product as a pharmacist?

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