In my 15 plus years as a licensed pharmacist I have never seen so many people, including healthcare professionals and respected media outlets, misrepresent the properties of a drug. You have seen the headlines and statements:
“Is The Super Potent New Opiate Painkiller Zohydro Just Too Dangerous?”
“A new opiate painkiller with 5 to 10 times the power of Vicodin.”
“States try to block new powerful painkiller Zohydro.”
“What puzzles all of us is the recent FDA action to approve a new opiate that's stronger and likely to be even more addictive because of its strength.”
These are just a few statements about Zohydro ER (hydrocodone Extended Release Capsules) that was approved October 2013 for chronic pain management and has since faced extreme backlash. Zohydro is the first and only extended release hydrocodone without acetaminophen. Listening to all the commentary, which all sound the same, you would think that mention of the name Zohydro will turn you and loved ones and everyone you know into zombie addicts. What is even more shocking is that there is little mention of those who Zohydro may potentially help.
Are we really so indifferent to the suffering of those with chronic pain and the challenges of chronic pain management that we focus so much on the few that may abuse opioids? The calls for withdrawing Zohydro are really saying that chronic pain patients have enough options and they do not need Zohydro. Is this really true?
As stated by the American Academy of Pain Medicine “100 million Americans suffer from pain and treatment of pain in the Unites States cost half a trillion dollars per year. Pain is one of the most common reasons people consult a physician. Yet it frequently is inappropriately treated.”
To clarify and address some of the misconceptions floating around in social media and news outlets let's examine the arguments for banning Zohydro and clarify facts from fiction.
Zohydro is a super potent opioid pain killer
The common belief is that Zohydro is a very potent pain killer and media sources have painted a picture that Zohydro is the most potent opioid pain killer available. That is quite far from the truth. Scientists classify Hydrocodone, the active ingredient in Zohydro, as a mid potency opioid drug. It has similar potency as oxycodone and methadone. Fentanyl is more potent than all of them.
The confusion in the media may stem from the misuse of the word potency. Potency in pharmacology is the effect of a drug on milligram per milligram bases. What is the effect of a drug per milligram? For example, the effect of one milligram of fentanyl is equivalent to about 100 milligrams of hydrocodone (Zohydro)—fentanyl is 100 times more potent than hydrocodone. Hydrocodone, methadone, and oxycodone are equal in potency, in other words equipotent. Oxymorphone, the active ingredient in Opana is more potent than hydrocodone.
Zohydro is 10 times more potent than Vicodin
This statement makes no sense since the opioid in Vicodin is also hydrocodone. Milligram for milligram hydrocodone in Vicodin and Zohydro are the same potency (see potency definition above). Zogenix the manufacturer of Zohydro has not reformulated hydrocodone to increase its potency. If they tried to make such a claim the FDA will levy heavy penalties on them. However, the media is planting this erroneous seed. What the media really is trying to say is that Zohydro is available in higher dosage strengths than you would find in Vicodin. Zohydro dosage strengths are 10, 15, 20, 30, 40, and 50 mg. The highest Vicodin strength has 10 mg of hydrocodone.
It is accurate to say a Zohydro 50 mg capsule has 5 times more hydrocodone than Vicodin 10 mg? That would be correct but only part of the picture. We must also consider that Zohydro is given twice a day because it is an extended release drug while Vicodin is given 1 to 2 tablets every 4 to 6 hours (4 to 6 times daily) because it is an immediate release formulation. Therefore someone taking two 10 mg tablets of Vicodin every 4 hours will take 12 tablets or 120 mg of hydrocodone in 24 hours. That compares to someone taking 50 mg twice daily (100 mg) of Zohydro. Let's also remember that Vicodin contains 300 mg of acetaminophen and in our example 3600 mg of acetaminophen will also be ingested by the Vicodin recipient. The maximum dose of acetaminophen is 4000 mg daily. Looking at this scenario just how potent is Zohydro compared to Vicodin? Is it really 10 times more potent? Do practitioners really want to subject patients with chronic moderate to severe pain to acetaminophen which is not useful for severe pain and causes liver failure?
For completeness the dosage strengths for oxycodone (OxyContin) are 10, 15, 20, 30, 40, 60, 80 mg. Should we now conclude that OxyContin is much more potent than Zohydro because its highest dosage strength is 80 mg?
Zohydro is likely to be more addictive than other opioids
There is no scientific bases for this statement. All opioids are addictive. However, individuals derive different degrees of pleasure from each type of opioid and it varies for each individual. There is certainly no scientific bases to state that Zohydro will be more addictive than Vicodin or other hydrocodone containing drugs or oxycodone.
We do not need another opioid painkiller
This suggests that clinicians have adequate tools for managing chronic moderate to severe pain which is a very difficult condition to treat and in under treated. Here are some reasons chronic pain patients need more options:
- Disease progression
- Lack of response
- Opioid-induced hyperalgesia (new or worsening pain caused by opioids)
- Side effects
The FDA should withdraw Zohydro
This is simply not going to happen unless the FDA can show Zohydro is not effective or less safe than other opioids. For this same reason and probably other legal reasons the Massachusetts ban on Zohydro will not stand. In fact a Federal judge just lifted the ban on sale of Zohydro in Massachusetts.
Zohydro should contain acetaminophen to deter abuse
This already exists in the form of Vicodin, Lortab, Norco and the various generic formulations. These drugs are actually less safe than Zohydro because of the risk of liver damage due to their acetaminophen component. Acetaminophen limits the usefulness of combination narcotics in treatment of moderate to severe chronic pain and this difference is why Zohydro is important to patients with chronic pain. Is acetaminophen really preventing the abuse of combination opioids? If so why is Vicodin and similar drugs so widely abused?
No one can ignore the prevalence and real consequences of opioid abuse. However, opioid dependence is a side effect that can be prevented. Fear of opioid abuse should not prevent the proper and responsible treatment of pain when use of an opioid is appropriate. Preventing the marketing of Zohydro will not change the incidence of opioid dependence but it may prevent access to another treatment option for chronic pain.
The Zohydro backlash is a widespread display of the stigma of addiction that causes unnecessary withholding of opioids and under treatment of pain. Healthcare providers should educate themselves on the proper use of opioids and how to maximize their benefit while reducing the risk of addiction.