New Painkiller Zohydro Concerns Addiction Experts, Physicians

Thursday, 27 Feb 2014 02:25 PM

By Michael Mullins

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The new painkiller Zohydro, which is expected to hit the markets in March, is of extreme concern to addiction experts, physicians, and others who have urged U.S. health officials with the Food and Drug Administration (FDA) to block the launch in a recently sent letter.

Zohydro, an opioid drug manufactured by the San Diego, Calif.-based Zogenix Inc., is said to contain a potent amount of opioid analgesics, which potentially could be lethal to children and new patients, according to those asking the FDA to revoke its approval of the prescription painkiller, Reuters reported.

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"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," the letter continued.

Zohydro was approved by the FDA in October 2013 for patients with pain that require "daily, around-the-clock, long-term treatment" that cannot be addressed with other drugs, the agency said at the time.

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

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

Since the late 1990s, deaths connected to prescription opioids have more than quadrupled in the U.S., from 4,030 deaths involving the painkillers in 1999 to 16,651 deaths in 2010, according to the Centers for Disease Control and Prevention (CDC).

Despite the increase of painkiller-related deaths over the past 15 years and the numerous risks being claimed by opponents, Zohydro's maker Zogenix says the new drug's benefits far outweigh the risks.

"We do not expect the introduction of Zohydro ER (extended release) to increase the overall use of opioids," Dr. Brad Galer, executive vice president and chief medical officer at Zogenix, said in an e-mail to CNN. "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."

FDA spokeswoman Morgan Liscinsky said the agency would review the group's letter.

In October, the FDA acknowledged the widespread abuse of opioid drugs across the country, writing that the agency "has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."

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