FDA Program for Reducing Unsafe Opioid Prescribing and Adverse Events Fails to Produce Clear Results
It is unclear whether the government’s strategy for reducing unsafe opioid prescribing and adverse...
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“We are facing an opioid epidemic—a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” FDA Commissioner Scott Gottlieb, M.D., said in a press release announcing the agency’s formal request in June that Endo stop selling the medication. The action by the FDA was “the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse,” the release stated.
While other opioids such as morphine and oxycodone are also abused, an article appearing today in Psychiatric News PsychoPharm describes how the Opana ER tablet is somewhat unusual: contributing to some of its deadly consequences are the inactive ingredients.
The older version of Opana ER tablet, which had been on the market from 2006 to 2011, was a simple formulation that released a small and steady amount of oxymorphone over 12 hours to maintain continuous pain relief. In 2012, after reports of people abusing the medication by crushing the tablet and snorting the powder, Endo replaced the original Opana ER tablet with a new formulation that contained a polymer known as polyethylene oxide (PEO) to make the tablet difficult to crush. If mixed with water, the tablet turns into a gel-like substance. The company had hoped to win the FDA’s “abuse-deterrent” label for this formulation, but the agency rejected the request, noting that it did not reach the standard for abuse deterrence.
Reformulated Opana ER deterred snorting, but individuals soon discovered that it was easier to “melt” and dissolve the tablet with heat. The liquid could be injected intravenously to produce the desired effect—a practice that led to more dangerous outcomes than snorting the tablets, Psychiatric News PsychoPharm reports. The article describes outbreaks of HIV and hepatitis C, as well as cases of a serious blood disorder known as thrombotic microangiopathy that can be traced back to injection abuse of Opana ER.
For more information on oxymorphone, the FDA’s action, and a list of 10 opioid analgesic products that have received the designation by the FDA as being “abuse deterrent,” see the full article here.
Today’s issue of Psychiatric News PsychoPharm also includes information on when to recommend SAMe for depression, findings that suggest imipramine may benefit patients with multiple somatic disorders, and more.
(Image: iStock/Mordolff)
