OxyContin Overdoses, Abuse Lead FDA to Approve New Tamper-resistant Pill

Federal regulators have approved a new tamper-resistant pill that they hope will reduce the risk of OxyContin overdose and drug abuse. 

The FDA issued a news release on Monday announcing approval of a new formulation of the OxyContin pill that makes it difficult to override the controlled release of the drugs into the body. The new design is resistant to efforts to cut, chew, crush or dissolve the pill in order to defeat the slow drug release design.

OxyContin is a form of the narcotic oxycodone that is designed to release the painkilling medication into the bloodstream gradually over a 12-hour period. Approved by the FDA in 1996, drug abusers quickly discovered that the pill could be crushed and snorted or inhaled for an instant high. Often referred to on the street as “Hillbilly Heroin” or “Killers,” the drug has been linked to hundreds of drug overdoses and deaths.

The pill is the best-selling prescription pain medication in the United States, with more than $2 billion in annual sales.

In 2007, Purdue Pharma executives plead guilty to criminal charges that they made false and misleading statements downplaying the risk of Oxycontin addiction to doctors. Sales representatives were told to tell doctors that the drug did not cause euphoric highs and was not as addictive as other pain medications. They also told doctors the drug did not cause withdrawal symptoms.

Company executives agreed to pay $600 million in fines for their actions, and made a number of settlements on individual Oxycontin lawsuits filed against the company on behalf of people who had become addicted to the drug and suffered injuries, financial losses, overdoses or death.

The FDA will require OxyContin’s manufacturer, Purdue Pharma, L.P., to conduct a postmarket study to see how the new pill design affects the rates of OxyContin abuse and misuse. FDA officials say the improvements are much needed, but anticipate that they will have an “incremental” effect on OxyContin misuse.

In 2008, about half a million people used OxyContin for non-medical reasons for the first time, according to data collected by the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health.