The U.S. Food and Drug Administration (FDA) recently asked Endo International to remove one of its opioid painkillers from the market. The request was eventually respected and the company recently stated that it would pull Opana ER. The FDA made the request after determining that the risks of the drug were not outweighed by its benefits to patients.

Opana ER and Opioid Drug Abuse

The heart of the matter in the recent pulling of Opana from shelve is the opioid drug abuse epidemic. Opana is a brand name drug for the generic oxymorphone. Like other opioid drugs, oxymorphone is based on the natural compounds found in opium, from the opium poppy. These substances are susceptible to abuse and have led in recent decades to an epidemic of abuse, addiction, and overdose deaths. While drugs like Opana are effective at managing pain, they come with the serious risk of abuse and addiction.
The FDA first approved Opana ER in 2006. Endo International developed the drug to provide continuous pain management with an extended release formula. Abusers discovered that the pills could be crushed to get the entire dose at once, and in 2012 Endo reformulated the drug to make it more difficult to abuse it in this way.

Opana Abuse and Disease Outbreak

The newly formulated Opana did not, according to the FDA, have any impact on the level of abuse of the drug. Furthermore, the agency determined that abuse of Opana led directly to an outbreak of a few diseases among abusers. Before the reformulation of Opana ER, abusers mostly crushed and then snorted the pill to get high. With the new formulation the method of abused shifted from snorting to injecting the drug into veins.

This shift is what led to a disease outbreak. The sharing of needles among Opana abusers led to an outbreak of serious infectious illnesses, including HIV and hepatitis C. It also led to a serious blood disorder among abusers, called thrombotic microangiopathy, in which blood clots form inside small blood vessels.

Request and Removal

The FDA’s advisory committee reviewed the information on Opana ER, its newer formulation, the rates of abuse, the disease outbreaks, and the benefit of the drug for patients dealing with chronic pain, and voted 18 to 8 to state that the risks of this drug do not outweigh the benefits. This led directly to the official request to Endo that the company remove Opana from the market. The request was for voluntary removal, and if Endo refused the request, the FDA would likely have taken steps to remove approval for the drug.

The FDA request came in early June and one month later Endo released a statement saying that it would comply and remove Opana from the market. The company also stated that it stands behind the safety and efficacy of Opana, and its risk-benefit profile, when used according to directions. Sales for Opana ER for the first quarter of 2017 were $35.7 million. Patients who are using Opana now are urged to talk to their doctors about alternatives. Endo hopes to work with the FDA to remove Opana in a timely way that will not be disruptive to patients currently prescribed the drug.