Zohydro. Is it a road to pain relief or a path to destruction? That depends on how it is used.
Some legislators and law enforcement officers want the FDA to pull approval for the new powerful painkiller, Zohydro, which is an extended release formulation of pure hydrocodone. However, the new formulation provides another weapon in the arsenal to fight chronic pain.
Hydrocodone is a relatively old drug that has been on the market for decades under brand names such as Vicodin and Lortab. Those formulations contain acetaminophen along with hydrocodone. Acetaminophen, the active ingredient in Tylenol, is hard on the liver. While hydrocodone combination drugs are among the most popular pills for prescription opiate addicts, they can’t be made to pack a more powerful punch by crushing and snorting or injecting them.
Zohydro, which just hit the market, when taken as prescribed, releases a certain amount of the drug over a 12-hour period. But it can be crushed to circumvent the timed-release action and then snorted, ingested or injected, creating a high that can be deadly.
This is what happened with OxyContin when it first entered the market, leaving a trail of addicts and overdose victims in its wake. The makers of OxyContin retooled and introduced a tamper resistant pill that when crushed simply becomes flat rather than a fine powder making it difficult to circumvent the time-release action.
“I see this will become the abuse drug of choice, and I see more overdoses and overdose deaths,” Bowling Green-Warren County Drug Task Force Director Tommy Loving said about Zohydro “It will be the OxyContin epidemic that we dealt with in the early 2000s. This will at least be comparable to that.”
Kentucky sees about 82 drug overdose deaths per month.
Hydrocodone is already the most common opioid prescribed in the United States, said Bowling Green pain management physician, Dr. Ram Pasupuleti of The Center for Pain Management. Ninety-eight percent of the hydrocodone produced in the world is consumed in the U.S.
“There are plenty of countries that don’t have hydrocodone,” he said. “They do OK. How much is needed or not needed is hard to say. We have to ask ourselves why are these numbers like that.”
Earlier this month, Congressmen Stephen Lynch, D-Mass., and Hal Rogers, R-Ky., introduced the Act to Ban Zohydro. The bill seeks to withdraw approval for the drug in a formulation that is not abuse deterrent.
“While the FDA continues to send mixed signals to drug companies about the need to invest in abuse deterrent technologies, the Act to Ban Zohydro will make it abundantly clear – life saving measures are critical to the development of powerful painkillers like Zohydro,” Rogers said in a release. “Someone dies every 16 minutes from a prescription drug overdose, making it the leading cause of accidental deaths in the United States.
“In southern and eastern Kentucky, we lost nearly an entire generation when crushable OxyContin was first prescribed, and I fear this crushable, pure hydrocodone pill will take us backwards with a new wave of addiction and tragic, untimely deaths. While there isn’t a silver bullet, abuse deterrent formulations offer common sense measures to curb the tide of overdose deaths in this country,” Rogers said.
Van Ingram, executive director for the Kentucky Office of Drug Control Policy, agrees that the pills should have an abuse deterrent feature.
“We’re very concerned about it,” Ingram said. “Our state’s history with extended release opioids is not a good one.
“We really were the epicenter of the OxyContin epidemic,” Ingram said. “When they changed it to an abuse deterrent formulation, that drug became much less used on the streets. This medicine comes at a high dosage with an extended release feature that when it is crushed and snorted or injected, it will release 12 hours worth of medication that will go directly to the brain in seconds that will produce a very euphoric effect and dangerous one. I’ve heard some physicians have said that an opioid naive person could overdose.
“We just feel like it would have been more prudent” to wait until the company could release an abuse-deterrent formula, he said.
As a pain management doctor, Pasupuleti sees both advantages and disadvantages of Zohydro.
“The advantage of Zohydro is, one, it does not have any Tylenol. Two, it is an extended release pill. It lasts 12 hours,” Pasupuleti said.
“Is it good or bad? It’s a very difficult question for me to answer. What I personally feel, it is a pain medication which has been around for along time, the only difference now is it is an extended release form.
“The Zohydro does not have the popular tamper resistant technologies,” he said. “Does it make it easier for people to abuse it? Yes, it does. But to be fair, a lot of other opioids in circulation do not have tamper-resistant formulations. I’d be happier if it had a tamper-resistant formulation. That would make it safer.
“It is dangerous if it is not used properly,” Pasupuleti said. “Even if it is used properly, any (opiate) pain medication can kill a person. There is a chance that it will stop them from breathing. Doses need to be adjusted to age and physical condition.”
Pasupuleti urges doctors who prescribe pain medication to do their “due diligence.” First, establish that a person truly has a need for pain management and treat the cause of the pain. Try injections, physical therapy and even surgery when that could fix the problem creating the pain. Then, he said, follow state law and conduct a Kentucky All Scheduled Prescription Electronic Reporting record to make sure the patient isn’t receiving pain medications from other physicians in the state and require patients to sign a contract that they will not abuse or divert their pain medications. Also, conduct routine urine drug screening on patients.
Even though there are many narcotic pain medications on the market, Pasupuleti explained that Zohydro has a place.
“There are a lot of choices, but what we need to realize is that every patient processes a medication differently. I have a lot of patients who hydrocodone doesn’t work for them. Each person processes opioids completely different,” he said. Pasupuleti has patients where only one medication works for them and they have to find that medication.
Pasupuleti expects that he will prescribe Zohydro when he sees a patient with a true need for that medication.
“A good example would be a patient who has been taking hydrocodone for the past 10 to 15 years. A patient like that, it probably makes a little more sense. The biggest advantage is that they don’t have to get the dose of Tylenol every day. Any person with chronic pain who has been used to opioids before would be a good candidate.”
For someone who has not been on opiate therapy, “it would not be my first drug of choice for sure,” Pasupuleti said.
“It definitely has a place in pain management for people in pain, but like any opioid, you have to be cautious in prescribing that medication.”