For the first time, federal drug regulators are calling for a drug recall, due to the high risk of abuse, indicating that problems linked to Endo Pharmaceutical’s Opana ER outweigh the benefits provided by the extended release opioid.
The FDA issued a press release on June 8, announcing that it has requested that Endo initiate a voluntary Opana ER recall, saying that the drug, which was supposed to be “abuse deterrent”, has been linked to widespread problems and has contributed to outbreaks of HIV and hepatitis C.
If Endo does not heed its request to remove Opana from the market, the FDA will take action to have the drug forcibly recalled.
Opana ER is Endo Pharmaceutical’s extended-release version of the opioid oxymorphone, and was just approved by the FDA in 2012, replacing the original version released in 2006, with a design that was supposed to prevent the pills from being crushed and inhaled. However, the FDA has determined that the drug is still widely abused, especially after the reformulation was made to deter addicts from snorting it. This pushed many addicts to begin injecting the drug instead.
The addition of needles has added another dimension to Opana ER’s abuse, resulting in an outbreak of HIV and hepatitis C. The drug has also been linked to a blood disorder known as thrombotic microangiopathy.
The FDA determined that Opana ER needs to be recalled from the market after a study of postmarketing data and recommendations by an independent advisory committee in March, which voted that the Opana ER risks outweigh its benefits.
Opana injections were the main cause of an HIV outbreak in Indiana in 2015. Addicts began injecting Opana to bypass the abuse-deterrent aspects. It also becomes 10 times more potent than morphine when injected. More than one user will share one quarter of a pill, leading to more needle sharing.
A study by the U.S. Centers for Disease Control and Prevention indicated users must inject Opana several times a day because of its short half-life, which causes withdrawal symptoms to begin much sooner. Users melt the gel coating, which creates the extended release effect. They then crush and mix the drug with a significant amount of water. The diluted solution forces the user to inject several times a day.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the press release. “This action will protect the public from further potential for misuse and abuse of this product.”
Endo received $158 million in sales on Opana ER in 2015 and said it is weighing all of its options while still claiming that Opana ER is safe and effective when used as directed.