"The benefits of original OxyContin no longer outweigh its risks," FDA says
The drug is attractive to abusers who crush it to snort, or melt and inject it
Reformulated pills from Purdue Pharma make the drug more difficult to abuse
Any generic version seeking approval should be based on the new formula, FDA says
In an effort to curb prescription painkiller abuse, the Food and Drug Administration is banning generic versions of the original OxyContin formula.
“The FDA has determined that the benefits of original OxyContin no longer outweigh its risks,” the agency said in a statement.
OxyContin was first approved in 1995. The drug became attractive to abusers who crushed it to snort, or melted and injected it. OxyContin tablets have a time-release formula that delivers the drug over a 12-hour period. But when a pill is crushed, the entire dose is immediately absorbed into the bloodstream.
Purdue Pharma, the producer of OxyContin, stopped selling the original formula to pharmacies in August 2010 after reformulating the pills to make them crush-resistant.
The reformulated pills make the drug more difficult to inject or snort, according to the FDA. The agency has approved new labeling for the drug that makes it clear the pills are more difficult to abuse. Any generic version of OxyContin that is submitted for approval should be based on this formula, the FDA says.
Prescription painkillers have killed more Americans than heroin and cocaine combined, according to the Centers for Disease Control and Prevention. Approximately 12 million Americans over the age of 12 reported using prescription painkillers recreationally in 2010. According to the CDC, enough were prescribed that year to medicate every American adult around the clock for a month.
Deaths have skyrocketed during the past decade. In 2009, about a half a million people visited emergency rooms as a result of abusing or misusing prescription drugs like Vicodin (hydrocodone), OxyContin (oxycodone), Opana (oxymorphone) and methadone, the CDC found.
In May 2007, Purdue Pharma settled a lawsuit that alleged the company used promotional materials that contained misleading or inaccurate data and downplayed the addiction risks of OxyContin, according to Fortune. The company paid a $600.5 million fine and three of the company’s top executives pleaded guilty to a misdemeanor count of misbranding.
In December, the White House Office of National Drug Control Policy sent an alert to law enforcement, particularly along the Canadian border, warning that Canada had approved non-abuse-resistant generic versions of oxycodone, the active ingredient in OxyContin, Percocet and about 40 other painkillers.
“ONDCP expects companies will begin offering these generics without the abuse-resistant features in Canadian pharmacies within the next month,” according to the alert.
The letter warned of the potential for these generics to show up in the United States.
Going forward, the FDA will continue “to encourage the development of abuse-deterrent formulations of opioids,” the agency said. “(We believe) that such products will help reduce prescription drug abuse. At the same time, the FDA remains committed to ensuring that patients with pain have appropriate access to opioid analgesics.”
CNN’s Saundra Young contributed to this report.