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New drug raises concerns locally

Painkiller Zohydro ER has medical professionals on edge

POSTED: March 29, 2014 11:29 p.m.

A new drug that was recently approved by the Food and Drug Administration has raised concerns both locally and nationally about its potential for abuse.

Zohydro ER was approved in October 2013 for the management of pain severe enough to require daily, long-term treatment when alternative treatments have proven inadequate. It will be the only pill on the market that contains hydrocodone, an opioid found in common pain medicines such as Vicodin and Lortab, without additives and in an extended release formula.

The drug has local anti-drug abuse activists and medical professionals on edge.

“We are concerned about it because of its high potential for abuse,” said JP Banks, director of the Drug Free Coalition of Hall County. “It has such a high potency. It can be crushed, which means it can be abused by snorting or injecting it, as opposed to Lortab, which is not time-released and not as potent.”

Roughly 25 people die a year in Hall County from accidental drug overdoses, Banks said, and about 50 percent of county high schoolers say that prescription drugs are easy to get.

Most of the controversy surrounding Zohydro centers around its extended release formula and the fact that it has no tamper-resistant mechanism. Because the drug is intended to deliver the hydrocodone over a long period of time, it contains a large amount of the drug. Zohydro can be prescribed in pills ranging from 10 milligrams to 50 milligrams, which is as much as five times the strength of current hydrocodone medicines.

“The lack of tamper-resistant technology means that you can get all of those milligrams at one time,” said Dr. P. Tennent Slack of Northeast Georgia Physicians Group and co-chairman of the anti-prescription drug abuse “Think About It” campaign and doctor of interventional pain management. “Instead of having to take several pills, now you can get the equivalent amount all at one time.

“That can be very dangerous, and that is what makes it attractive.”

Tamper-resistant mechanisms prevent potential abusers from crushing the pill, which in turn prevents them from snorting it or injecting it.

This concern has plagued Zohydro even before it was approved. The FDA’s own Advisory Committee overwhelmingly voted against approval, stating that “the FDA should not approve (extended-release and long-acting) opioids without tamper-resistant or abuse-deterrent formulations.”

The FDA made no mention of the committee’s recommendation in its press release about the drug’s approval.

Last week, Georgia Attorney General Sam Olens joined five other state attorneys general to write a letter urging U.S. Department of Health and Human Services Secretary Kathleen Sebelius to overturn the FDA approval.

“The Centers for Disease Control and Prevention has already labeled the nation’s prescription drug abuse problem an epidemic,” Olens said in a press release. “Introducing another powerful drug into the market could increase the risk for abuse, overdoses and deaths. I urge Secretary Sebelius to seriously consider the concerns raised in this letter and overturn the decision of the FDA.”

Earlier this month, U.S. Sen. Joen Manchin, D-W.Va., spoke out against the approval, and congressmen Stephen Lynch, D-Mass., and Hal Rogers, R-Ky., introduced a bill that would withdraw approval of Zohydro and prohibit the FDA from approving such drugs without an abuse deterrent formulation.

The same sentiment is echoed by professionals here in Hall County.

“We have multiple other opioid options out there,” Slack said. “Why is there a rush to bring a new one onto the market without taking the time to put tamper-proof technology on it?”

The Associated Press contributed to this story.


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