The maker of the long-acting painkiller Opana ER has agreed to stop marketing the drug as crush-resistant, under a settlement with New York State. The company also agreed to accurately describe the risk of addiction to the drug, Reuters reports.
Under the agreement with New York State, Endo Health Solutions and Endo Pharmaceuticals will also pay a $200,000 penalty, according to New York State Attorney General Eric T. Schneiderman. He said the company’s own studies found Opana ER could be crushed and ground. “This may have bolstered Opana ER sales, but provided a false sense of security to health care providers and their patients,” according to a statement by Schneiderman’s office.
The Attorney General also found that Endo improperly instructed its sales representatives to “diminish and distort risks associated with Opana ER, including serious dangers involving addiction,” Schneiderman’s office stated.
The Attorney General found that Endo made unsupported claims comparing Opana ER to other opioids, and failed to disclose accurate information regarding studies addressing the effects of Opana ER.
Endo, in a statement, said it was “deeply committed to patient health and safety,” and said it welcomed the attorney general’s support toward reducing opioid prescription abuse.
The company said it will create an Abuse and Diversion Detection Program that requires its sales representatives to report to the company health care providers it suspects of engaging in abuse and illegal diversion of opioids. The company pledged to cease marketing opioids to problem prescribers.
Endo will post results of clinical studies on its website; encourage health care providers to seek training on appropriate opioid prescribing practices; and give health care providers information about addiction treatment resources for their patients.
Published
March 2016