FDA Reclassification of Hydrocodone

The FDA has announced that it intends to reclassify analgesics that contain hydrocodone from schedule III to schedule II, which means, among other things, that prescriptions can no longer be written for refills. More prescriptions are written for Vicodin (and its generics), a combination of hydrocodone and acetaminophen, than for any other drug in the US, and the ease of obtaining refills may well have contributed to its popularity. For treatment of pain, hydrocodone has been available here only in fixed-dose combinations with acetaminophen or ibuprofen, but the FDA recently announced approval of an extended-release, single-entity hydrocodone (Zohydro ER), which we will review in an upcoming issue of The Medical Letter. Single-entity hydrocodone will be a schedule II drug.

Opioids, unlike NSAIDs, have no ceiling on their analgesic effects. The only limitations are imposed by their side effects, which we reviewed in our April, 2013 article in Treatment Guidelines from The Medical Letter on Drugs for Pain. Sedation, dizziness, nausea, vomiting, pruritus, sweating and constipation are the most common adverse effects of opioids; respiratory depression is the most serious. Tolerance usually develops rapidly to the sedative and emetic effects of opioids, but not to constipation, which is often a major problem for people who take these drugs chronically. Opioids also can increase prolactin levels and reduce levels of sex hormones, resulting in reduced sexual function, decreased libido, infertility, mood disturbances and bone loss.

I think the FDA is doing a good thing here. The US will be a better, safer place with hydrocodone in or out of combination consigned to schedule II.

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