Alarmed Healthcare Providers Ask FDA to Reverse Approval of Powerful Painkiller

Friday, February 28, 2014

The Food and Drug Administration (FDA) has been asked three times in recent months to reconsider its decision to approve a powerful new painkiller that critics say will become the next OxyContin crisis.


Zohydro, a hydrocodone-based drug, is set to become available in March, following the FDA’s approval of it last fall.


The painkiller is said to be five times stronger than similar drugs already on the market.


This week, a group of more than 40 healthcare, consumer, and addiction-treatment organizations wrote (pdf) to the FDA urging it to revoke Zohydro’s approval.


Their effort follows similar calls by a collection of state attorneys general in December and a group of congressional lawmakers in November for the FDA to think twice about making the drug available for sale.


“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,” 42 members of the coalition stated in a letter to FDA Commissioner Dr. Margaret Hamburg.


One of the signatories, Dr. Andrew Kolodny, president of the advocacy group Physicians for Responsible Opioid Prescribing, warned Zohydro “will kill people as soon as it’s released,” according to CNN.


Other experts not involved in the petition to the FDA have expressed strong reservations about the drug.


“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, told CNN. “I’m five times more concerned, solely based on potency.”


Health experts have been alarmed about the rising number of fatal prescription-drug overdoses, particularly those involving opioids. Such deaths have more than quadrupled, going from 4,030 in 1999 to 16,651 in 2010.


Zohydro’s manufacturer, Zogenix, insists the drug will prove a benefit to society.


“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 email 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.”

-Noel Brinkerhoff


To Learn More:

New Pain Pill's Approval: 'Genuinely Frightening' (by Stephanie Smith, CNN)

Zohydro: The FDA-Approved Prescription for Addiction (by Andrew Kolodny, Huffington Post)

Letter to FDA (Fed Up! Coalition) (pdf)

FDA Overrules Expert Panel to Approve High-Potency Painkiller (by Danny Biederman and Noel Brinkerhoff, AllGov)


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