FDA
The US Food and Drug Administration (FDA) has requested that a formulation of oxymorphone hydrochloride, marketed as Opana ER, be withdrawn from the market due to abuse, saying that the benefits of the product no longer outweigh the risks.
The drug was voluntarily reformulated by the manufacturer Endo Pharmaceuticals in 2012 with a tablet coating to prevent abuse through snorting.
But Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research said this had led to “dangerous unintended consequences”, as it shifted the route of abuse to injection, precipitating the largest HIV outbreak in the history of Indiana. The reformulation has also been linked to the spread of hepatitis C and cases of thrombotic microangiopathy.
The decision to call for its removal was taken at a meeting of an independent FDA advisory committee in March. The FDA said the data did not support the idea that the manufacturer’s reformulation had succeeded in reducing abuse of Opana.
The FDA says that while its request for the manufacturer to withdraw the drug from the market is voluntary, if Endo Pharmaceuticals does not cooperate, it will begin taking formal action to remove the drug’s approval.
This is the first time the FDA has requested the removal of an opioid product from the market for public health reasons. It is reviewing all approved opioid products in response to the country’s opioid abuse epidemic. The Centers for Disease Control and Prevention says that 91 people now die every day from opioid overdose, a figure that has been driven by a more than four-fold increase in the number of fatalities from prescription opioids since 1999.
