FDA on Thursday announced that it has asked Endo Pharmaceuticals to voluntarily withdraw its extended-release opioid Opana ER from the market.
The move, which follows a review of the drug's post-marketing data, marks the first time FDA has taken steps to remove an opioid from the market over misuse concerns, the agency said.
If the company fails to comply with the agency's request, FDA said it will take action to formally remove Opana ER from the market by withdrawing the drug's approval. In the interim, FDA said it will warn health care professionals and others of the opioid's misuse risks.
Reasons behind FDA's request
FDA asked Endo to pull the drug off the market after an FDA advisory panel comprised of independent experts in March determined that Opana ER's benefits might no longer outweigh its risks.
FDA said a review of post-marketing data revealed a "significant shift in the [drug's] route of [misuse]" from individuals snorting the drug to them injecting it. According to FDA, the misuse of the drug via injection has been linked to cases of a serious blood disorder, known as thrombotic microangiopathy, as well as an outbreak of HIV and hepatitis C in Indiana in 2015, where individuals shared needles to inject the drug.
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, said, "When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market."
If Endo removes the drug from the market, U.S. residents would no longer have access to the extended-release version of Opana, which FDA approved in 2006.
The new formulation was designed to make the drug resistant to physical and chemical tampering for misuse by snorting or injecting, but FDA determined that the drug did not "meaningfully reduce" misuse. Instead, FDA said data show the reformulated opioid led to a "significant shift" in misuse patterns "from nasal to injection."
Sidney Wolfe, founder and senior adviser at Public Citizen, said, "If Endo resists taking this off the market immediately, ... there will be a wave of product liability litigation against the company."
FDA Commissioner Scott Gottlieb said, "We are facing an opioid [misuse] epidemic—a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse." He added that FDA "will continue to take regulatory steps when we see situations where an opioid product's risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse."
Endo in a statement said it is "reviewing the request and is evaluating the full range of potential options as [it] determine[s] the appropriate path forward." The company added that it "remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients."
Andrew Kolodny, a director at Brandeis University's Opioid Policy Research Collaborative, said he hopes the move means FDA will adopt a tougher approach to regulating opioids.
Kolodny said FDA has done very little in recent years to curb opioid misuse, even though "it was clear prescribing had taken off at a rate much greater than could be clinically needed." He added that the agency should have not continued approving opioids for sale as misuse and overdose rates climbed nationally (Stein, "Shots," NPR, 6/8; FDA release, 6/8; Gever, MedPage Today, 6/8; Clarke, Reuters, 6/8; Whalen, Wall Street Journal, 6/8).
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