In a press release dated June 8, 2017, the FDA said that after careful consideration, the agency is seeking removal of the opioid painkiller Opana ER based on its concern that the benefits of the drug may no longer outweigh its risk for drug abuse.
This unusual request is the first time the federal agency has ever asked a pharmaceutical company to voluntarily stop selling a medication because of the risk of abuse associated with the drug.
The FDA’s decision to have the drug removed from the market is based on a review of all post-marketing data after the drug was reformulated which showed a distinct shift in the route of abuse of Opana ER from nasal to injection. Injection abuse of the painkiller has been associated with a serious outbreak of HIV and hepatitis C, as well as an outbreak of a serious blood disorder (thrombotic microangiopathy).
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement, reports Live Science.
“When we determined that the product had dangerous and unintended consequences, we made a decision to request its withdrawal from the market,” Woodcock said. “This action will protect the public from the further potential for misuse and abuse of this product.”
The FDA’s move could signal a major change in the way the agency is responding to the out-of-control opioid epidemic in the United States and could lead to the FDA requesting that more opioids be removed from the market. Over 183,000 people have died from overdoses linked to prescription opioid painkillers like oxycodone, hydrocodone, fentanyl, and morphine over the last 15 or more years.
In 2012, Endo Pharmaceuticals reformulated Opana, giving it abuse-deterrent properties, turning the pill into a gel capsule. However, in 2013, the FDA found Opana was still easy to inject or snort despite the new formulation. In 2015, Opana was blamed on a serious outbreak of HIV in Indiana that resulted in 165 cases of the disease.
The CDC interviewed 112 people related to the HIV outbreak and found that 96 percent of them had injected Opana using shared needles.
In a press release, Endo said it was reviewing the FDA’s request and stood up for its drug — when used as intended.
“Endo 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,” the company wrote.
Newly appointed FDA commissioner Scott Gottlieb said in a statement, according to AOL.com, “We 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.”
