As the national opioid crisis rages, painkiller manufacturers have raked in profits and earned plaudits by reformulating their opioids in an attempt to deter abuse.
But on Tuesday, a federal advisory panel delivered an extraordinary rebuke to one such product on the market, suggesting that Endo Pharmaceuticals’ efforts to make Opana ER harder to crush ended up making things worse by enabling addicts to inject it.
A committee of anesthesiologists and other experts who advise the Food and Drug Administration voted 18 to 8, with one abstention, that the benefits of the powerful painkiller do not outweigh its risks. Opana has been blamed by some for spurring a high-profile HIV outbreak in rural Indiana in 2015, and it was also tied to reports of a rare but serious blood disease characterized by clots that can lead to organ damage.
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