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Experts Concerned over FDA’s Newly Approved Opioid

Update Date: Feb 26, 2014 09:43 AM EST
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The United States Food and Drug Administration's (FDA) recently approved pain killer has raised concerns. The drug, Zohydro is a hydrocodone-based drug that is a part of the group of drugs known as opioid analgesics. These drugs have been tied to addiction, which is why a coalition of more than 40 health care, consumer and addiction rehabilitation groups have pushed the FDA to revoke its approval.

"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 reported by CNN. "Too many people have already become addicted to similar opioid medications, and too many lives have been lost."

Zohydro was approved by the FDA last fall and will be available for patients with chronic pain in March. According to another expert, Dr. Andrew Kolodny, the president of the advocacy group, Physicians for Responsible Opioid Prescribing, the drug contains a huge dose of hydrocodone packed into each capsule. The drug capsule is also very easy to crush, which suggests high risk of abuse.

In November of last year, members of Congress asked the FDA to consider reviewing its decision to approve the drug. One month later, 29 state attorneys general also sent the agency a letter about their concerns. The experts agreed that if this drug is released next month, it could lead to fatal cases.

"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 was not involved with the most recent petition. "I'm five times more concerned, solely based on potency."

The FDA and drug-manufacturing company, Zogenix have stated that the drug was approved because the benefits outweighed the risks. The FDA reported that the drug has been categorized as Schedule II, which the agency and the drug company believe will lower the risk of abuse.

The drug will be sold with warnings regarding abuse, addition and misuse. Zogenix reported that an abuse-deterrent version of the opioid could be available in three years.

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