Fight Looms as Arizona, Other States Seek Tighter Controls on Painkiller Zohydro ER

A new prescription painkiller that was recently approved by the Federal Drug Administration (FDA) has public officials in some states, including Arizona, scrambling to ban the drug.

The drug, called Zohydro ER, according to various media reports, is as much as 10 times stronger than other painkillers. In Arizona, the Attorney General has signed a letter requesting that the FDA take back its approval of the drug.

Two east coast states have already made getting the drug more difficult. Vermont Gov. Peter Shumlin announced an emergency order that makes it harder for doctors to write prescriptions for Zohydro ER. In Massachusetts, Gov. Deval Patrick issued an outright ban on Zohydro ER prescriptions.

U.S. Sen. Joe Manchin (D-W.Va) and U.S. Reps. Stephen Lynch (D-Mass) and Hal Rogers (D-Ky) introduced separate bills last week to ban Zohydro ER and any future drug formulations that lack abuse-deterrent mechanisms. The FDA has been considering such a ban, which is also being sought by attorneys general from 29 U.S. states (including Arizona).

Why All the Uproar?

Because it is so much stronger than other prescription painkillers, the main fear is that people will abuse Zohydro ER. Since it comes in a capsule, the powder inside can be taken out and either snorted or injected by users.

Zohydro ER is an opiate – just like oxycodone and heroin – and that has public health officials worried that its abuse could lead to a new wave of painkiller addiction in Arizona and across the nation and the world. Some critics have said it’s like taking 10 Vicodin in one pill. The drug also has no safety coating, it’s not crush-proof, and a child picking it up off the floor could die from overdose.

For its part, the maker of the drug, San Diego-based Zogenix, first had countered with a statement that Zohydro ER “is no more potent than any other hydrocodone medication available,” and that “there are many marketed opioids that are more potent than hydrocodone such as oxymorphone, methadone, hydromorphone and fentanyl.”

Zogenix then issued a statement saying that Massachusetts’ ban on Zohydro ER unfairly restricts access “to the only hydrocodone pain reliever available for long-term, daily, severe chronic pain patients” obtaining relief from short-acting hydrocodone combination products, “but who are at risk for potentially fatal liver toxicity due to their daily intake of acetaminophen.” (Zohydro ER contains no acetaminophen.)

Now, the drug maker has sued Massachusetts in federal court, seeking to overturn that state’s ban on the sale of Zohydro ER even as it’s taking steps to ensure doctors and patients understand the drug’s risks.

What Are the Risks of Zohydro?

As an opioid painkiller, Zohydro ER has a number of risks which are clearly identified in boxed warning and safety information. These include:

  • Zohydro ER exposes users to risks of addiction, abuse and misuse, which can lead to overdose and death.
  • Serious, life-threatening respiratory depression may occur.
  • Accidental consumption of Zohydro ER, especially in children, can result in fatal overdose.

Zohydro ER contains hydrocodone, a Schedule II controlled substance, although Zohydro ER is a combination drug currently classified under Schedule III. In addition to the risks of addiction, abuse and misuse, as a modified-release product, Zohydro ER delivers the opioid over an extended period of time. This poses a greater risk for overdose and death due to the larger amount of hydrocodone present.

What will be the fate of Zohydro ER? Lawsuits take time. Expect a volley of publicity as pro- and anti-Zohydro ER camps weigh in over the next few months. Chronic pain patients who need such medication shouldn’t be restricted from receiving prescriptions for the drug, but stricter controls, possibly reclassification of the drug and other abuse-deterrent mechanisms may be on the horizon for Zohydro ER.

Posted on November 5th, 2014

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