Citing Addiction Fears, Group Asks FDA To Revoke Painkiller Approval

In an unusual move, a coalition of activists and physicians, concerned about the problem of prescription pain-reliever abuse, yesterday asked the U.S. Food and Drug Administration to revoke its approval of a new type of opioid called Zohydro. The medication is expected to be on the market soon.

“Too many people have already become addicted to similar opioid medications and too many lives have been lost,” said the Feb. 26 letter to the FDA, signed by a coalition of consumer health advocates, addiction treatment and health care providers.

But that request is provoking outrage and anxiety among chronic pain patients who applauded the FDA’s approval of the new medication last fall and would like to see Zohydro added to the list of prescription pain-relievers now on the market.

Zohydro is a type of opioid called hydrocodone and, in its chemical structure, is similar to morphine, said June Dahl, a professor of neuroscience at the University of Wisconsin School of Medicine and Public Health, in a telephone interview and email conversation.

“It’s an advantage to have another pure opioid agonist on the market and to have that agonist in a controlled release formulation,” said Dahl. She questioned, however, whether it is wise to allow the current formulation of Zohydro on the market right away, instead of waiting a few years for an abuse-deterrent, a formulation specifically designed to thwart abusers.

Until recently, the only hydrocodone-containing products on the market were combination medications such as Vicodin which contains both hydrocodone and acetaminophen. The major concern about Vicodin is actually not the opioid it contains but the acetaminophen (which is also the active ingredient in Tylenol), noted Dahl. (Last fall, the FDA took the first steps toward moving medications like Vicodin to a more restrictive category, which would limit the how easily patients could get refills.)

Zohydro is different from Vicodin in that it contains only hydrocodone, with no other ingredients. The company that makes Zohydro argues that this formulation makes the drug safer than the combination products.

Dr. James Cleary, a palliative care specialist at the University of Wisconsin, said in a telephone interview that “it is reasonable to have this product [Zohydro] out there.” Opioids are defined as “essential medications” by the World Health Organization and several other major groups, he added.

“Therefore we need to make sure they are available to appropriate patients and we need to establish a balanced system that also reduces abuse and diversion. We need to understand the opioid crisis much better.”

After a lengthy study, FDA scientists issued a report in October, 2013 saying that Zohydro appears to be safe, effective and should be on the market like other medications that are also long-acting. The FDA report recommended that Zohydro be classified as a Schedule II drug, the second most restrictive class of medications.

Here’s more from the CNN report:

In December, 29 state attorneys general sent a similar letter to the FDA. The month before, members of Congress asked the agency to review its decision to approve the drug.

The concerns echoed by all groups are broadly about the drug’s potency and abuse potential. They say they fear that Zohydro — especially at higher doses — will amplify already-rising overdose numbers.

“This could be the next OxyContin,” says a petition on Change.org asking the FDA to reconsider.

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