Endo International of Malvern to pay penalty related to Opana ER drug
Endo International P.L.C. has reached a agreement with the New York Attorney General to stop marketing its Opana ER painkiller as crush resistant, and to stop understating the addiction risks with the opioid narcotic.
Endo International P.L.C. has reached a agreement with the New York Attorney General to stop marketing its Opana ER painkiller as crush resistant, and to stop understating the addiction risks with the opioid narcotic.
Endo, with U.S. headquarters in Malvern and global headquarters in Ireland, will also pay a $200,000 penalty, State Attorney General Eric Schneiderman said in a statement Thursday.
Under the terms, Endo must provide "truthful and complete information" about Opana ER's addiction risks.
The company must create a program to prevent its sales staff from promoting the powerful narcotic to doctors and health-care providers who may be abusing and illegally diverting opioids. Endo must cease marketing to those doctors.
Endo marketed Opana ER as crush resistant, when the company's own studies showed that the pill could be crushed and ground, the attorney general said.
The misleading marketing may have boosted Opana ER's sales, and provided "a false sense of security" to doctors and patients.
"Endo is deeply committed to patient health and safety," said Matthew Maletta, Endo executive Vice President and chief legal officer. "We therefore support efforts to curb opioid prescription abuse and we believe that enhancing those efforts, including through anti-diversion programs, is an effective use of time and resources."
The company said it "welcomed" the input from the New York Attorney general and other stakeholders "as we continually evolve and improve our anti-abuse programs, while maintaining appropriate access to safe and effective medications for the approximately 100 million Americans suffering from chronic pain."
Endo has about 380 employees in Malvern and 6,000 worldwide.
"Numerous New York health-care providers who were heavily 'detailed' by Endo were subsequently convicted of illegal prescribing of prescription opioids," Schneiderman said.
The attorney general's office began investigating Endo's marketing practices after Nassau County issued a public health alert in May 2011 on the increasing abuse of Opana ER.
In July 2012, USA Today reported that Opana ER had become the drug of choice for people seeking narcotics, and that in Nassau County hundreds of people each month were seeking treatment for addiction to Opana ER.
Between 2008 and 2011 the number of opioid painkiller prescriptions filled by New York City residents increased by 31 percent, from about 1.6 million to about 2.2. million, Schneiderman said.
The Centers for Disease Control and Prevention said overdose deaths from opioids in New York State increased five-fold from 179 in 2003 to 883 in 2012.
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