Product News and Recalls

Opana ER Pulled from Shelves Over Abuse Concerns

sales of opana halted by FDAEndo Pharmaceuticals has officially withdrawn Opana ER from the market at the FDA’s request. The extended release opioid medication recently became the subject of an inquiry by the agency because of the specific way it was being abused.

Opana ER was designed to slowly and steadily medicate a patient as an extended release medication. However, when crushed, snorted, or injected, an abuser can get the full dose in a shortened period of time. Endo had previously attempted to resolve this problem by changing the coating of the drug in order to impede such misuse. While the effort succeeded in curbing inhalation, it led to more injections, which contributed to the spread of HIV and other blood-borne pathogens via the sharing of dirty needles.

Although Opana’s removal from pharmacy shelves is being touted as voluntarily, such a claim is dubious at best. Less than a month ago, the FDA requested that Endo Pharmaceuticals halt the sale of Opana because of how the drug has been feeding into the national opioid crisis. The agency threatened to force the removal and pull its approval if the corporation didn’t act on its request.

The FDA’s concerns over Opana are legitimate – extended release opioid medications are even more addictive than their non-extended release cousins. But it also calls into question why the agency approved the drug in 2006 in the midst of the opioid epidemic, and why it would take them more than a decade to then turn on it and force its removal.

It is also worth noting that the FDA’s approach to Opana could be have been applied to any number of powerful opioids that the agency has approved; drugs that are also just as deadly and just as responsible for an abuse crisis that is almost unrivaled in its scope and impact on the nation. However, no such action has been taken as fentanyl continues to ravage and destroy addicts and their families. Nor has any significant attention been paid by federal authorities to the discovery that the nation’s largest prescription drug distributor shipped nearly 100 million doses of hyrdocodone and oxycodone to West Virginia; enough to give nearly 1,000 pills to every man, woman, and child in the entire state.

In a separate statement regarding Opana, the FDA said that “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.” That may imply additional action is on the horizon for other drugs. But given the agency’s extensive track record of inaction throughout this time; a time when opioid overdoses quadrupled between 1999 and 2015, Americans may find it difficult to take the bluster seriously until they see defined legislation that actually impacts the use and availability of these extremely addictive drugs.