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FDA Approves Opioid Zohydro Without Abuse-Deterrent Formula

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By Rheyanne Weaver
Created 10/31/2013 – 06:09
Opioid-Zohydro Approved by FDA
A new powerful painkiller called Zohydro was approved by the FDA last week, yet many experts are concerned about the new opioid’s lack of ingredients that deter people from abusing it.
This approval comes during a time when prescription drug abuse is notoriously high, and other drug makers have been required to make formulas that help prevent abuse.
The drug Zohydro is considered a single-entity hydrocodone pill that uses extended release capsules, according to an FDA news release.
The FDA issues the following warning statement in its news release:
“Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with [extended-release/long-acting] opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”
Mental health experts have their own opinions about what this new opioid on the market could mean for people at risk for prescription drug abuse.
Dr. Kenneth Thompson, medical director at Caron Treatment Centers, said in an email that “hydrocodone is already one of the most abused opioids.”
“Making it available in a long-acting form, when attempts are being made to tighten controls on prescription drugs that contain this ingredient, is dangerous and potentially lethal,” Thompson said.
“There have been many deaths associated with abuse of the slow release version of OxyContin before it was reformulated, and abuse of prescription painkillers is a growing epidemic.”
He said there are already many other options for pain management so he doesn’t think it’s wise to release yet another opioid option.
“It’s difficult to say if it will cause an increase in prescription drug abuse, but it certainly doesn’t help the current public health crisis,” Thompson said.
Thompson lists some common signs and symptoms of opioid abuse in women:
1) “Excessive mood swings or hostility.”
2) “Changes in sleep.”
3) “Stealing, forging or selling prescriptions.”
4) “Consistently ‘losing’ medication so new prescriptions must be written.”
5) “Borrowing money or spending excessive amounts of money without explanation.”
6) “Appearing to be revved up or alternatively sedated.”
Dr. Michael H. Lowenstein, medical director of the Waismann Method® Medical Group, is board certified in pain medicine, addiction medicine and anesthesiology.
He said in an email that it’s surprising the painkiller was approved due to all the bad press surrounding drugs like Oxycontin, which could be crushed and easily abused.
“The FDA required the makers of Oxycontin and Opana ER to develop tamper resistant technologies,” Lowenstein said. “I am very surprised that this was not required for a medication that contains hydrocodone, the most abused prescription pain medication in the country.”
There is also the fact that the FDA went against its own advice.
“It had met with resounding negative reviews the year before by the agency’s own outside board of advisors,” Lowenstein said.
He said a drug like Zohydro could be particularly dangerous, especially for people prone to prescription drug abuse, because it is 10 times more potent than Vicodin, and it doesn’t contain acetaminophen.
Previously, Lowenstein said that people addicted to drugs like Vicodin would still try to limit their dose because acetaminophen (Tylenol) can cause liver damage in high doses.
“By eliminating the fear of liver injury, people might feel it is safer to use higher and higher dosages, which could result in an increased risk of respiratory depression and death,” he said.
He added that at first the cost and availability will be a deterrent to people looking to abuse the drug, but eventually abuse and overdose will happen.
For women who take drugs like Zohydro, Lowenstein said it’s important to be aware of the tendency for increased tolerance and to increasingly use the drug for emotional pain.
“One of the most important things is not to confuse the effects of the physical pain relief caused by the opiate with the overall sense of well-being opiates can have on your emotions,” Lowenstein added.
“When patients request an increase in their medication in the absence of new or further injury, it is very important to question them about depression, anxiety, insomnia and increased stress, and if present to treat these issues with appropriate medication and therapy.”
Sources:
Fiore, Kristina. FDA OKs Drug Without Anti-Abuse Protection. Web. October 30, 2013.
http://www.medpagetoday.com/PainManagement/PainManagement/42511
U.S. Food and Drug Administraction. FDA approves extended-release, single-entity hydrocodone product. Web. October 30, 2013.
https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm395456.htm
Fauber, John. FDA OKs high-dose narcotic painkiller Zohydro, raising abuse concerns. Web. October 30, 2013.
http://www.jsonline.com/watchdog/watchdogreports/fda-oks-high-dose-narco…
Thompson, Kenneth. Email interview. October 30, 2013.
https://www.caron.org/about/caron-experts/kenneth-thompson
Lowenstein, Michael. Email interview. October 30, 2013.
https://www.naatp.org/facility/waismann-method-medical-group/
Reviewed October 31, 2013
by Michele Blacksberg RN
Edited by Jody Smith

 
Source: EmpowHER, October 31, 2013.

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