HealthDay News — Drug users who dissolve and inject the oral “abuse-deterrent” version of Opana ER (oxymorphone) — an opioid painkiller — may be at risk for thrombotic thrombocytopenic purpura (TTP), according to the CDC.
“Healthcare providers who prescribe Opana and pharmacists who dispense it should inform patients of the risks from the drug when used other than as prescribed,” David Kirschke, MD, of the Tennessee Department of Health, and colleagues, wrote in Morbidity & Mortality Weekly Report.
The new Opana ER formulation became available in February 2012. Tennessee health officials launched a statewide in August 2012, after three cases of unexplained TTP — a rare but serious blood disorder with an annual incidence of about one in 100,000 — were reported in IV drug users residing in a rural county in the northeastern part of the state.
By October, 15 cases were identified, none of which were fatal. Upon further investigation, the researchers discovered that in 14 cases the patients had been dissolving and injecting Opana ER, an opioid pain reliever intended for oral use.
Thirteen of the cases involved women, who are at greater risk for TTP than men, and the overall sample ranged in age from 22 to 49. Seven cases were treated for sepsis in addition to TTP. In 12 cases, chronic hepatitis C or positive test results for anti-hepatitis C virus antibody were reported.
Patients reported symptoms characteristic of TTP, including nausea, abdominal pain, fatigue, and fever, according to the CDC.
“Healthcare providers should ask patients with TTP-like illness of unknown etiology about any intravenous drug abuse. Suspected cases can be reported to public health officials,” Kirschke and colleagues wrote.
It is unclear what aspect of the reformulated medication is causing the blood disorder, but it is unlikely that it is due to adulterated product, the researchers noted. At least two of the patients got their drugs directly from a pharmacy, and all of the communities involved are far enough apart to make a single, nonmedical source unlikely. But the problem could be related to some component of the method used to prepare the drug for injection, they suggested.
Last week, the FDA issued it’s first draft guidelines for developing abuse-deterrent opioids, a technology the agency recognized as being relatively new.