FDA Issues New Warnings on Painkiller OxyContin

July 26, 2001 (Washington) -- The FDA announced Wednesday that it had put its strongest possible warnings on labels of the potent prescription narcotic OxyContin.

The agency is concerned about continuing abuse and illegal diversion of the pain drug, which the FDA says has an "addiction potential similar to that of morphine." The changes were made in cooperation with the drug's maker, Purdue Pharma.

The new labeling includes a "black box" warning and is intended to change prescribing practices and to make physicians more aware of the possibilities of illegal use. The FDA is concerned that doctors have prescribed the drug for short-term, mild pain, whereas it is approved only for constant, moderate-to-severe pain that is expected to last a long time.

"A number of medical professionals have been responsible for prescribing it wantonly," especially in rural areas, says Chuck Miller, an official with the U.S. Department of Justice's National Drug Intelligence Center.

But the drug's misuse can also involve "doctor swapping," where patients obtain prescriptions from different doctors and fill them at a range of pharmacies to avoid detection. Others abusers are getting false prescriptions for themselves and then selling the drug to others.

In a document posted on its web site, the FDA warned patients who are taking OxyContin to "protect your prescription and your medication from theft and never give OxyContin to anyone else. You should destroy any leftover OxyContin tablets that you may have once your physician instructs you to stop taking the medication."

The drug is meant to be swallowed whole, delivering pain relief for up to 12 hours. But dozens of deaths have been associated with illegal use of OxyContin, usually when an individual crushes the tablets to snort or inject the drug, which produces an intense but potentially deadly high.

With its long-acting strength, OxyContin has been heralded as a breakthrough in the treatment of pain. But it's become a household name from news reports of its abuse in Appalachia and other rural areas of the East Coast. Federal and state enforcement authorities -- and the drugmaker -- are stepping up efforts to battle what some say is an epidemic of illegal use of the medication.

Reports of the drug being diverted into illegal channels began several years ago in Maine, Purdue says. Abuse has now expanded to states including Virginia, West Virginia, and Kentucky.

Doctors wrote six million prescriptions for OxyContin last year, says Purdue Pharma. The drug is not only the company's leading product but also the nation's biggest-selling opioid pain medication.

Meanwhile, the drugmaker is vigorously fighting lawsuits such as a complaint filed in June by the Attorney General of West Virginia alleging that OxyContin has been marketed aggressively and deceptively to physicians for the treatment of minor pain. That marketing, the suit says, has forced the state to spend significantly on addiction treatment efforts.

According to Art Van Zee, MD, who practices for Stone Mountain Health Services in rural southwestern Virginia, "Commonwealth attorneys in the surrounding counties note that at least 70% of the serious crimes in the area are now drug related. Not a week goes by that we are not talking with a number of parents about their young adult children that are losing their vehicles, jobs, families, and homes to this opioid addiction."

In May, Purdue Pharma announced it was temporarily suspending shipments of the highest-dose version of the tablets, saying it was "concerned about the possibility of illicit use of tablets of such high strength."

Meanwhile, the Drug Enforcement Administration, or DEA, wants further restrictions. Rogene Waite, aspokesman for the DEA, tells WebMD that it's very important that the manufacturer reformulate the drug so it can't be easily abused. That would mean altering the drug so that it can't be crushed for a rapid high.

But the DEA can't force Purdue to abide by its proposed restrictions. Purdue says, for its part, that legitimate patients are complaining that some insurance plans are not covering the additional tablets they must take under lower-dose versions of the drug.

Purdue has mailed educational brochures to hundreds of thousands of doctors and pharmacists to prevent "diversion" of the drug, as well as providing tamper-resistant prescription pads and spending money on public education efforts.

Quick solutions to curb the abuse of the drug are crucial, since the problem may be spreading.

Miller told WebMD that there are now reports of OxyContin abuse in northern Florida. "We're seeing also increased use of OxyContin in the younger population," he says, "and it's moving into urban areas," including parts of Washington, D.C., and Philadelphia.