Subscription is FREE for qualified healthcare professionals in the US.

Zohydro Debate: Drug Hysteria or True Concern

Page 1 of 2

Much has been written about the controversy surrounding the release of Zohydro (hydrocodone), which won Food and Drug Administration approval despite a 12 to 2 vote against the agent by the advisory committee.

Many experts in pain management and drug psychiatry are concerned that the new drug will become another focal point in the country’s epidemic of opioid abuse. Multiple letters have been sent to the FDA by attorneys general, drug addiction groups, pharmaceutical reform advocates, non-profit awareness groups, and numerous doctors warning the FDA that Zohydro is not ready for the public.

Zohydro could be easily abused, critics say. According to Andrew Kolodny, MD, co-founder of Physicians for Responsible Opioid Prescribing, the pill could be tampered with to give abusers an immediate rush instead of receiving the drug’s effects over the prescribed 12-hour time frame.

“I am all for people getting good pain relief,” wrote David Healy, MD, an expert in psychopharmacology, the founder of Data Based Medicine Limited and one of the co-signers in the letter of protest recently sent to the FDA by a coalition of experts and doctors in the field of pain management, pharmacology and addiction. But pain relief “cannot all be about medications,” Dr. Healy wrote in an email to Practical Pain Management.

Precautions Listed

Zogenix, the manufacturer of Zohydro, has released statements on their website about the drug with warnings about its use. “Zogenix is committed to ensuring the appropriate use of Zohydro,” the company wrote. They noted that the drug “should be reserved for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

Julie Nomart, a company representative for Zogenix, has said that the company is working on developing safety caps and a chart for takers of the drug to try to prevent abuse and dependency. Zogenix also wrote that the drug is not meant to be prescribed as a use-when-needed analgesic.

Much Needed Agent

According to Lawrence Robbins, MD, Zohydro is a much needed new pain drug, and “a better version of the existing forms of hydrocodone [Vicodin, Norco].” In a guest editorial submitted to Practical Pain Management, Dr. Robbins lays out these argument:

Zohydro has none of the acetaminophen that the other hydrocodone tablets contain, eliminating the risk to the liver and kidneys. For a typical 3 times per day prescription of Vicodin/Norco, switching to Zohydro will save patients from being assaulted with 30,000 mg per month of acetaminophen, 360,000 mg per year. Over years, acetaminophen may increase the risk for kidney dysfunction. The liver toxicity associated with acetaminophen is well documented.

In addition, Zohydro is long acting, lasting 8 to 12 hours, much longer than the 2 to 4 hours for the current Vicodin and Norco versions. Zohydro will eliminate the withdrawal felt after 3 hours of a short-acting painkiller. Zohydro is highly controlled, difficult to obtain, and requires additional paperwork and a special prescription. Zogenix is marketing the drug very conservatively. Only select physicians will be prescribing Zohydro.

Unfortunately, there has been an unwarranted firestorm of hysterical protest over Zohydro. On February 26-27th, just prior to the drug’s launch, multiple print, TV, and radio outlets ran pieces slamming the drug. Every review of Zohydro was negative. The only physicians interviewed were addiction specialists, who do not treat chronic pain. Incredibly, the media chose to omit the opinions of pain specialists and patients. A number of media outlets used the exact same words to describe Zohydro, most likely obtaining their statements from information written by a competing drug company. This is a multibillion-dollar class of drugs, and competing companies will gain hundreds of millions of dollars if the FDA withdraws Zohydro.

“Some of the falsehoods perpetuated by the media were:

Zohydro will kill people as soon as it is released (nobody has died)

  • Zohydro is 10 times stronger than Vicodin (it is the same strength)
  • It only takes 1 or 2 tablets to kill a patient (untrue)
  • Children who take 1 pill will die (unlikely, and how will a child have access?)
  • This is the worst decision by the FDA, a disaster and tragedy for this country (it was the right decision)
  • Zohydro is more powerful than anything on the market (it is actually the least powerful opioid in its class, when compared to oxycodone or morphine)

The media parroted these statements, each more ridiculous than the last, without any balanced opinion by an expert in pain medications.

Last updated on: May 19, 2015
First published on: May 1, 2014