As our blog followers and much of the opioid media and political opioid-vote-seekers know, controversy surrounding Zohydro ER has exploded in the past three weeks. Just today, the American Academy of Pain Management issued a Statement on Extended-Release Hydrocodone (Zohydro ER), also available on their website that mirrors much of the discussion outlined below. This blog will help separate fact from the array of fictions that some lawmakers, governors and state attorneys general are spewing forth. Then we can debate the real issues.
First, let’s start with the sound bites being splattered throughout the media. Please note: none of the responses to the statements below are debatable. The responses are based on science.
Statement: “Zohydro ER will result in overdoses because it contains PURE hydrocodone.”
Duh. All prescription drugs approved by the FDA contain pure drug. Lortab and Vicodin each contain PURE hydrocodone and PURE acetaminophen. The hydrocodone in Zohydro ER is no more or less PURE than any other prescription hydrocodone.
Statement: “Zohydro ER is 5-10x more potent than Lortab or Vicodin.”
No. Hydrocodone is equipotent to morphine and about 20-30% less potent than oxycodone. The hydrocodone in Zohydro ER is still hydrocodone. It is no more or less potent than the hydrocodone in any other prescription drug. Any “experts” who have been quoted in the mainstream media as stating otherwise should be embarrassed and review pharmacology 101.
Statement: “There’s no need for Zohydro ER or an extended release hydrocodone.”
Untrue. Many patients are not able to tolerate certain opioids but can tolerate hydrocodone. There are five general chemical classes of opioids. Hydrocodone belongs to a class known as phenanthrenes, more specifically dehydroxylated phenanthrenes. There are two other oral products available in that chemical (dehydroxylated) class, OxyContin (oxycodone extended release) and Opana (oxymorphone extended release). Both brand named products have abuse deterrent (AD) technology, however the generic form of Opana is not AD, just like Zohydro ER. Some patients cannot tolerate drugs from the other chemical classes, and some cannot tolerate oxycodone; some patients don’t respond to some of the other options; some patients have drug-drug or drug-disease interactions precluding their use of other options.
Statement: “All other extended release opioids on the market have AD technology.”
False. The ones that DO NOT have abuse deterrent technology are all extended release brands and generics of morphine (and there are a lot of them), which as mentioned above is mg for mg equivalent to hydrocodone. Other extended release opioids that DO NOT have AD formulations are generic oxymorphone ER, fentanyl transdermal, and Nucynta ER. Methadone is not an extended release product, but it hangs around for a long time in the blood – no methadone formulations have AD technology. The same is true for levophanol.
Statement: “There’s no need to have a ‘PURE’ hydrocodone.”
Untrue. Patients with elevated liver enzymes or documented significant liver disease should not take acetaminophen chronically. Also, there are several drugs that interact with acetaminophen, and, therefore, for some patients acetaminophen should be avoided.
Statement: “Zohydro ER will cause increased deaths because people will overdose it or snort it.”
Unclear. There are no data to support or dispute this because it hasn’t happened yet, nor do drug companies test patients in advance with a specific endpoint to see who dies.
This last item is the only debatable point. But, in my humble opinion, anybody that overdoses on Zohydro ER most probably died of natural causes, took more than prescribed, and/or combined the drug with other sedative-hypnotics that were not prescribed. Or the prescriber did something wrong or the dispensing pharmacist did something wrong.
I suspect that anybody who chooses to take more than prescribed, and/or combine the drug with other sedative-hypnotics that were not prescribed would have gotten hold of another opioid and overdose on that instead. So will opioid overdoses increase overall? Not likely. Will some people die from abusing this drug? Probably, but they likely would have died from another opioid, and if it was injectable heroin, they may have the pleasure of dying from an infectious disease such and HIV or Hep C or right-sided infectious endocarditis.
On the flip side, tens of thousands of people with legitimate chronic pain stand to benefit from Zohydro ER for the reasons outlined above.
So there you have it. Want to argue? Have at it!