Officials in Kentucky are suing a major pharmaceutical company that was recently forced to pull a painkiller off the market, alleging the company knowingly downplayed addiction risks.
Attorney General Andy Beshear filed the lawsuit Monday against Endo Pharmaceuticals alleging the company deceived the public about the abuse potential of their painkiller Opana ER, causing opioid overdose deaths in the state to spike. Beshear claims Endo overstated the pain management benefits of the drug while significantly downplaying addiction risks, giving doctors in the state a false sense of the pill’s safety, reports CNN.
Deaths in Kentucky from oxymorphone, the active ingredient in Opana ER, skyrocketed in 2011, representing 23 percent of all overdoses in the state. In 2010, oxymorphone accounted for 2 only percent of overdose deaths in Kentucky.
“Endo put its profits above the lives of our people and above patient safety,” Beshear said Monday, according to CNN. “Was Endo worried that people were now addicted to their drug? No. They were worried their profits would decline. They were worried about themselves.”
For the first time in history, the FDA ordered a drug maker to pull a medication off the market June 8 due to widespread reports of abuse. Endo Pharmaceuticals announced the decision to comply with the FDA request July 6 following an internal review of Opana ER.
The unprecedented move came in the wake of reports patients were crushing up the pills to inject. Representatives for Endo said they stand by the safety profile of Opana ER and believe the benefits outweigh the risks. They say the pill is safe and effective when administered properly, but will comply and work with the FDA on the issue.
The company also denies the allegations leveled against them in the lawsuit from Kentucky.
“The public statement made by Kentucky Attorney General Andy Beshear today in connection with filing suit against Endo that this organization and its dedicated employees seek to ‘line their pockets at the expense of communities’ is patently offensive,” Matthew Maletta, the executive vice president and chief legal officer for Endo Pharmaceuticals, told CNN. “We intend to vigorously defend the company against the claims set forth in this lawsuit.”
FDA Commissioner Scott Gottlieb recently warned the agency will get much more aggressive with drug makers, potentially forcing companies to pull more painkillers off the market. Addressing the National Press Club in Washington Nov. 3 Gottlieb argued the current opioid epidemic requires a much more “intrusive” response from federal regulators than previously expected.
The statements reflect the FDA’s new focus on not just the prescribed risks of painkillers, but the risks posed by illegal abuse of the pills.
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