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New Super Powerful Pain Medication Meets Severe Criticism Despite Federal Approval

Zohydro contains 10 times more hydrocodone than Vicodin and was approved by the Federal Drug Administration despite being condemned by its own advisory committee. Over 40 organizations are protesting the FDA's approval of the drug.

Posted on February 27, 2014, at 4:55 p.m. ET

Zohydro, a new pain medication, is an easily crushable pill that contains 50 milligrams of pure hydrocodone, 10 times more than Vicodin. The Food and Drug Administration approved the drug to treat chronic pain and it’s set to become available in March.

More than 40 organizations are urging the FDA to revoke approval of the drug. Many cite a growing problem with pill addiction and overdose. Even the FDA advisory committee voted 11-2 against its approval, but it was approved despite the vote.

AP Photo/Mel Evans

The drug is supposed to be prescribed to treat chronic pain, but many pain experts believe that opiates should only be used to treat short-term severe pain and to ease the pain of a patient nearing the end of their life.

Zohydro’s approval came a day after the FDA announced its concern about opiate abuse and proposed shifting drugs containing hydrocodone from Schedule III to Schedule II rating.

The U.S., particularly in parts of New England, has also seen a dramatic increase in addiction and death attributed heroin. Heroin is much cheaper than most prescription pills, so it becomes an appealing alternative when people addicted to pain medication are seeking a more accessible opiate.

According to Brad Galer, executive vice president and chief medical officer at Zogenix, creator of Zohydro, said that he doesn’t expect the introduction of the medication to “increase the overall use of opioids.” Here's the medication's warning label:

Emails have surfaced between two professors that had a history of organizing private meetings between FDA officials and pain medication manufacturing drug companies. The professors get paid thousand of dollars for this. One of the companies that attended these meetings was Elan Corporation, Zohydro's original manufacturer who Zogenix would go on to partner with.

"The problem is, it costs a lot of money bringing a drug through clinical trials and then bringing it to market. You have to anticipate (the drug company) being able to market and get its money back. I see this as a marketing ploy where eventually it's 'I've got bigger, I've got stronger, why don't you prescribe this,' and I'm terrified of that,” said Dr. Stephen Anderson, a past president of the Washington chapter of the American College of Emergency Physicians.