A powerful new prescription painkiller that’s packed with hydrocodone and provides 12-hour pain relief will be available in pharmacies in the next couple of weeks.
Both the manufacturer of Zohydro and the federal Food and Drug Administration say that the drug, a synthetic opioid, is safe if used correctly and is a necessary alternative for patients who have built up a tolerance to other opioids or can’t tolerate opioids mixed with other medicines.
But local addiction-treatment experts and families who have lost loved ones to opiate overdoses say the new drug will contribute to the deadly heroin and pain pill epidemic. For them, a new prescription opiate is the last thing needed on the shelves of drugstores.
“Zohydro is basically pure synthetic heroin and comes in pills as large as 50 milligrams,” said Avi Israel, a North Buffalo resident whose son, Michael, committed suicide in 2011 after struggling with an addiction to prescription painkillers for the treatment of Crohn’s disease.
Unlike other pharmaceutical opiate pain medications, Zohydro, an extended time-release capsule, consists of hydrocodone without the familiar additives of aspirin or acetaminophen, making it stronger than other painkillers.
The FDA approved Zohydro for public consumption last fall, though the decision was in direct opposition to the FDA’s own outside scientific advisory panel, which voted, 11-2, against approving the painkiller.
Law enforcement officials fear that the medication will fall into the wrong hands and that drug addicts will crush the capsules and consume the medicine at full strength, rather than as it was intended, dissolving over long periods.
“Because it is more pure, there is a high potential for abuse, and we’re going to be on the watch for abuse,” said Michelle Y. Spahn, the resident agent in charge of the Buffalo office of the FDA. “It’s unfortunate. It’s what we are up against. What will it be next year?”
Zogenix, the manufacturer of Zohydro, is not sugarcoating the potential dangers of the new drug, which faced strong opposition when it went through the review process for FDA approval.
The company says it is taking unusual precautions in introducing the medication, which is designed to provide extended relief from one 12-hour dose to the next and serve as an alternative for individuals who do not tolerate opioids that contain analgesics.
In a news release, San Diego-based Zogenix said that it has established an “external safe-use board” of experts in pain management, risk management, addiction, patient care and law enforcement who will meet quarterly to review assessments on the “benefit-risk profile” of the drug.
“Zogenix is committed to promoting the appropriate use of Zohydro ER through a comprehensive suite of voluntary initiatives, which include integrated educational resources for patients, prescribers and pharmacists, surveillance programs to identify misuse, abuse and diversion,” the company stated. The statement also noted the risks of addiction, overdosing and death in the prescribing of the drug.
Dr. Richard D. Blondell, a specialist in addictive medicine in the Buffalo Niagara region, said the risks of prescribing Zohydro far outweigh the benefits and will lead to more overdoses.
“The benefit of having an additional prescription painkiller on the market is pretty minimal when there are hundreds already out there,” said Blondell, who also serves as a professor and vice chairman for addictive medicine at the University at Buffalo’s department of family medicine.
“So when the risk exceeds the benefit, why do it? What’s driving this?” Blondell said, pulling his wallet out during an interview and waving a $20 bill. “The drug business is lucrative, both illicit and licit.”
A last-ditch effort to block Zohydro from entering the market was made a week ago when 42 members of the medical and addiction-treatment communities, along with advocates against the proliferation of pain pills, sent a letter to Dr. Margaret A. Hamburg, the FDA’s commissioner, detailing the dangers of the new opioid.
Urging that public health interests come ahead of the pharmaceutical industry’s interests, the letter cited how the United States is the biggest consumer of hydrocodone and oxycodone in the world and how that has resulted in a parallel increase in opioid addiction and overdose deaths in America.
“The highest available dosage of Zohydro will contain five to 10 times more hydrocodone than Vicodin or Lortab,” the letter stated. “Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child.”
The FDA on Tuesday issued a statement saying that it has not formally responded to the letter but explained that its goal is “to balance the important public health concerns around the misuse and abuse of extended-release opioids with the need for continued patient access to effective pain medications” and that Zohydro was approved after a careful review that met regulatory requirements.
This week, Sen. Charles E. Schumer, D-N.Y., urged U.S. Health and Human Services Secretary Kathleen Sebelius to overturn “a disastrous decision by the federal Food and Drug Administration that allowed an ultra-powerful painkiller to enter the market” in the early part of this month.
Zohydro, Schumer said, lacks adequate protections that would make it “sufficiently tamper-resistant.” Schumer wants the pills to be formulated in a way so that they could not be crushed and snorted or consumed in another unintended fashion.
Anne D. Constantino, president and CEO of Horizon Health Services in Western New York, which provides treatment for addictions, expressed concern that drug dealers will soon find a way to introduce Zohydro to addicts.
“When Zohydro hits the market , the other half of the distribution business is going to be busy figuring out how to procure their supply,” said Constantino, one of the people who signed the letter.
Despite the concerns and objections cited in the letter, the FDA appears to be standing by its justifications for Zohydro’s approval, which occurred last October when Dr. Janet Woodcock of the FDA stated that the drug’s benefits outweighed its risks, saying:
“Having an additional safe and effective option for opioid treatment is important for several reasons. First, individual patients respond differently to different opioids. A patient may experience better pain management and/or more tolerable adverse effects with one opioid compared to another.
“Second, the benefits of one opioid can wane as a patient becomes opioid tolerant. A common clinical practice strategy to address these issues is to rotate the patient from one opioid to another. Also, prescribers now have the option of moving a patient who is responding well to an immediate-release hydrocodone combination product but who would benefit from treatment with an extended-release formulation to Zohydro.”
Israel, the North Buffalo resident, believes that the FDA is wrong to approve the drug.
“That’s a serious mistake that Dr. Woodcock is making, saying she is willing to sacrifice lives so somebody can have relief from lower-back pain,” he said.
“The FDA advisory panel rejected the drug over concerns for its safety, not concern over whether or not there is a need for it on the market.”