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FDA Approves Opioid Zohydro Without Abuse-Deterrent Formula

By HERWriter
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Opioid Zohydro Without Abuse-Deterrent Formula approved by FDA Benis Arapovic/PhotoSpin

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.”

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EmpowHER Guest

Read Expert Opinion on Drug Safety’s FREE editorial discussing the recent controversial decisions at FDA on Zohydro ER http://bit.ly/1fQc9Sb
The paper discusses the recent decisions on hydrocodone medication; highlighting big inconsistencies in decision-making and discussing important implications for public.

March 12, 2014 - 4:21am
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We value and respect our HERWriters' experiences, but everyone is different. Many of our writers are speaking from personal experience, and what's worked for them may not work for you. Their articles are not a substitute for medical advice, although we hope you can gain knowledge from their insight.

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