Cocerns raised over potency of FDA-approved Zohydro pain pill

By Jenna Iacurci, Parent Herald February 26, 04:26 pm

Health care, consumer and addiction treatment groups are concerned about the newly FDA-approved Zohydro pain pill.

This coalition is urging the Food and Drug Administration to retract its approval of the prescription painkiller, classified under opioid analgesics, for fear of its potency and potential for abuse.

The medication was approved last fall to treat chronic pain and will be available to patients in March; however, that hasn't stopped concerned individuals from writing letters to the FDA asking the agency to take it off the market.

"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 groups wrote in a letter to FDA Commissioner Dr. Margaret Hamburg, reports CNN.

According to the Centers for Disease Control and Prevention, prescription opioid deaths have quadrupled since 1999 and these groups are worried that, based on its potency, Zohydro could contribute to this climb.

"You're talking about a drug that's somewhere in the neighborhood of five times more potent than what we're dealing with now," said Dr. Stephen Anderson, a Washington emergency room physician who is not a part of the current petition. "I'm five times more concerned, solely based on potency."

The maker of the drug, Zogenix, believes that Zohydro's benefit outweighs its health concerns.

"We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids," said Dr. Brad Galer, executive vice president and chief medical officer at Zogenix. "In fact, prescription data from the last five years shows that total use of ER opioids is constant and independent of new entrants to the market."

Galer added that the company would ensure only appropriate patients with chronic pain would receive the painkiller - those with low back pain, fibromyalgia, arthritis or other chronic conditions - if it's used like other opioids.

Meanwhile, the FDA has switched the drug to Schedule II (still pending approval by the Drug Enforcement Administration), meaning stricter dispensing and prescribing rules.

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