FDA Answers Critics About Extended-Release Hydrocodone Approval


The US Food and Drug Administration has issued a fact sheet addressing concerns about the dosage and abuse potential of Zohydro ER, approved last December.

The US Food and Drug Administration (FDA) has issued a fact sheet addressing concerns and objections to its approval late last year of Zohydro ER, an extended-release formulation of hydrocodone that does not include acetaminophen.

Key points:

1. Zohydro is the first extended-release long-acting opioid analgesic subject to new labeling changes including:
   --  a revised indication meant to encourage more "careful and thorough" decisions about prescribing it;
    --  more "pointed" warnings about abuse potential;
    --  instructions to monitor patients on the drug.

2.  FDA expects approval of Zohydro ER will not increase use of opioids because in many cases it will replace another opioid the patient was taking.

3.  REMS (Risk Evaluation and Management Strategy) policies require manufacturers to offer training to prescribers of this product.

See also: 

Hydrocodone Restrictions: What Will Happen and What You Can Do

The FDA and Hydrocodone

The fact sheet also addresses some "misperceptions:"

1.  That Zohydro ER is the most potent opioid ever licensed:  Containing 10 mg to 50 mg of hydrocodone released over 12 hours (immediate-release products contain 2.5 mg to 10 mg) it is actually less potent than certain strengths of other currently marketed extended-release opioids such as morphine sulfate, hydromorphone, oxymorphone, and oxycodone. FDA says it can deliver the same amount of analgesia per day with fewer doses.

2.  That the drug is at high risk of abuse because it doesn't include abuse-deterrent packaging or properties. FDA says abuse-deterrent technology is not perfected, and people who intend to abuse these drugs will always find a way around it.

The document concludes by placing physicians squarely on the front line of this battle: They "must play a key role and have a responsibility to ensure that they are treating patients based on their individual needs," receiving adequate training and following responsible prescribing practices to minimize abuse.

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