Zohydro ER: Mixed Messages in FDA Painkiller Advice
Written by Karen on October 30, 2013
The Food and Drug Administration has made two moves involving hydrocodone that can both help and hinder people addicted to painkillers. On October 24, the FDA recommended changing the restriction level of painkillers like Vicodin and Lortab, which contain the opioid hydrocodone combined with acetaminophen. The next day, the FDA approved a new extended-release, hydrocodone-only painkiller called Zohydro ER.
Hydrocodone is an opioid painkiller, much like oxycodone, although it has been treated differently. First, hydrocodone had only been sold in pills combined with other, non-opioid drugs like acetaminophen. The mixed dosage had been thought to be less addicting, although the use of acetaminophen can put patients at risk for liver damage if the drugs are used to excess. This combination meant that hydrocodone drugs were classified as schedule III by the Drug Enforcement Administration, which means they have ‘moderate to low potential for abuse.’ As schedule III drugs, they faced fewer restrictions (prescriptions could be called in, not written) and could be refilled more often.
The FDA is recommending that the hydrocodone drugs be moved from schedule III to schedule II, the grouping for oxycodone drugs and those with ‘high potential for abuse.’ If approved by the DEA, that change will make it harder for people to get and renew those prescriptions. That’s good news for people fighting opioid drug abuse, bad news for people with chronic pain.
The second drug approval is the flip side of that story. The FDA approved Zohydro ER, an extended-release, hydrocodone-only drug, which will be in schedule II, like oxycodone, as a chemical with high potential for abuse. The FDA acted against the recommendations of an outside advisory panel, which voted 11-2 against approving the new drug. The drug is an effective painkiller, but the panel thought its potential for abuse far outweighed the advantages of approving another addictive drug.
The concerns come from the lack of abuse-deterrent technology for Zohydro. OxyContin helped usher in the current era of opioid abuse because its original formula could be crushed or snorted for a high. In 2010, a new formulation of OxyContin made it difficult to crush or liquefy. The FDA has drafted a statement requiring abuse deterrence for new painkillers, but it has not been finalized and Zohydro was approved without them. Some doctors fear that Zohydro will become as abused as the original form of OxyContin.
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