Debate About Zohydro Safety Heats Up

Bill Proposes to Ban Zohydro Because of Drug Abuse Concerns

zohydroA West Virginia senator proposed a ban on the single-ingredient painkiller, Zohydro, citing questions about the drug’s safety.

Last month, the FDA approved an incredibly strong prescription painkiller –Zohydro, which critics worry is so strong it could negate any headway made in the war against prescription painkiller abuse.

“In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid,” the coalition wrote in a letter to FDA Commissioner Dr. Margaret Hamburg. “Too many people have already become addicted to similar opioid medications, and too many lives have been lost.”

“It’s a whopping dose of hydrocodone packed in an easy-to-crush capsule,” said Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing. “It will kill people as soon as it’s released.”

Now, US Senator Joe Manchin of West Virginia has proposed a bill that would ban Zohydro, despite the drug’s FDA approval.

“I have tried reasoning with the FDA, and I’ve repeatedly requested the agency change its course on this dangerous drug,” Manchin said. “Because of this painkiller’s high potential for misuse and abuse, Zohydro poses a severely dangerous threat to our communities in West Virginia and across our country.”

Manchin and other lawmakers have argued that the prescription painkiller about be abused, in large part because there are no ingredients that would slow down or stop the high created by the drug and therefore could increase the risk of abuse. The bill also proposes to ban the potential for future single-ingredient drugs like Zohydro that do not feature “tamper-resistant” ingredients.

FDA Chief Defends Zohydro Despite Public and Lawmaker Concerns

In the face of the new potential legislation, FDA Commissioner Dr. Margaret Hamburg defended the FDA’s choice to approve Zohydro.

Dr. Hamburg told Senators that the painkiller fills an “important and unique niche” to treat chronic pain.  She said that, because the drug is just hydrocodone and nothing else, there is much less potential for liver failure related to taking the pain medication. Other opioid painpainkillers, when taken regularly at high doses, increase the risk of liver toxicity or failure as a side effect.

Hamburg added that tamper-resistant ingredients are also in the early stages of development. To date, the agency has only approved one medication with such features – OxyContin, a strong but popular opioid painkiller prescribed to treat a variety of chronic pain.

“It doesn’t do any good to label something as abuse deterrent if it isn’t actually abuse deterrent, and right now, unfortunately, the technology is poor,” Hamburg said.

The Strom Law Firm Can Help with Charges of Prescription Painkiller Abuse

If you have received criminal drug abuse charges, or are suspected of abusing prescription painkillers, you are not automatically guilty, and you do not give up any of your rights. The attorneys at the Strom Law Firm can help defend you. We offer free, confidential consultations to discuss the facts of your case. Do not let criminal drug charges such as trafficking or possession ruin your reputation and career prospects. Contact us today. 803.252.4800.


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