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Outrage of the Month: Dangerous New Opioid Pain Drug Scheduled to Hit U.S. Market in March

Health Letter, March 2014

Michael Carome, M.D.

Barring an unprecedented decision by Food and Drug Administration (FDA) Commissioner Margaret Hamburg to reverse the agency’s October 2013 approval decision, a dangerous, powerful, high-dose opioid analgesic with the brand name Zohydro ER will become available by prescription in the U.S. this month.

Zohydro, the first single-ingredient hydrocodone drug ever approved by the FDA, will be marketed in doses ranging as high as 50 milligrams (mg) per capsule, a dose that could kill a young child if accidentally ingested.[1] Other hydrocodone-containing drugs, such as generic versions of Vicodin, contain only 5 to 10 mg of hydrocodone per tablet in combination with acetaminophen or another nonnarcotic active ingredient.

The FDA approved Zohydro on Oct. 25, 2013,[2] against the advice of its own advisory committee, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), which voted 11 to 2 against approving the drug.[3] The AADPAC concluded that in light of current public health concerns about opioid abuse and misuse, the FDA should not approve extended-release or long-acting opioids like Zohydro that lack tamper-resistant or abuse-deterrent formulations.[4]

The arrival of Zohydro on the U.S. market will come in the midst of what the Centers for Disease Control and Prevention has characterized as a growing epidemic of opioid drug overdose deaths in the U.S. From 1999 to 2010, deaths for opioid analgesic overdoses increased by more than 400 percent in women and 265 percent in men.[5]

On Feb. 26, 2014, Public Citizen joined with more than 40 other consumer advocacy and health care organizations, addiction treatment providers, professional groups, and community-based drug and alcohol prevention programs to strongly urge Hamburg to revoke the agency’s approval of Zohydro.[6] The coalition’s letter declared that “[i]n the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the last thing the country needs is a new, dangerous, high-dose opioid.”

Twenty-eight state attorneys general made a similar request in a letter sent to Hamburg on Dec. 10, 2013, stating:

We believe your approval of Zohydro ER has the potential to exacerbate our nation’s prescription drug abuse epidemic because the drug will be the first hydrocodone-only opioid narcotic that is reportedly five to ten times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties.[7]

Those on the front lines of the battle against the worsening opioid drug addiction epidemic recognize that the FDA’s reckless decision to approve Zohydro represents a remarkable failure to act in the best interests of protecting public health. Unless the FDA immediately reverses its decision, we likely may soon see a wave of preventable deaths due to unintentional and intentional overdoses of this dangerous drug.


[1] Rappaport BA. NDA approval letter for Zohydro ER. October 25, 2013. Accessed February 23, 2014. [see first paragraph on page 1]

[2] Food and Drug Administration. FDA news release: FDA approves extended-release, single-entity hydrocodone product. October 25, 2013. Accessed February 23, 2014.

[3] Food and Drug Administration. Summary minutes of meeting of the Anesthetic and Analgesic Drug Products Advisory Committee. December 7, 2012. Accessed February 23, 2014. [see page 6, vote on question 5]

[4] Food and Drug Administration. Summary minutes of meeting of the Anesthetic and Analgesic Drug Products Advisory Committee. December 7, 2012. Accessed February 23, 2014. [see page 6, discussion of question 5]

[5] Centers for Disease Control and Prevention. CDC website. Prescription painkiller overdoses: A growing epidemic, especially among women. July 2013. Accessed February 23, 2014.

[6] FED UP! Coalition to End the Opioid Epidemic. Letter to FDA Commissioner Margaret Hamburg. February 26, 2014. Accessed February 26, 2014.

[7] State Attorneys General from 28 states and Guam. Letter to FDA Commissioner Margaret Hamburg. December 10, 2013. Accessed February 23, 2014.

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