New labeling is intended to alter prescription practices
FDA gives OxyContin advisory
Manufacturer Purdue Pharma is sending letters to more than 800,000 health-care professionals explaining the changes.
By LAURENCE HAMMACK
The Roanoke Times
The warning label on OxyContin became more pointed Wednesday as the Food and Drug Administration and the drug's manufacturer announced new efforts to inform doctors and pharmacists of the drug's potential for abuse.
The initiatives are intended to limit use of the prescription painkiller to patients with serious pain, with the goal of reducing the drug's availability to those who abuse it. The changes took two forms:
OxyContin's package insert - the literature provided to doctors, pharmacists and others who dispense the drug - will now bear the FDA's strongest type of advisory. A so-called black box warning states that the drug has an abuse liability similar to morphine.
At the same time, manufacturer Purdue Pharma is sending letters to more than 800,000 health-care professionals explaining the changes to the package insert and alerting them to misuse of its drug.
The latest warnings are in response to increased reports that the powerful narcotic is being converted to a form of pharmaceutical heroin by abusers who crush the pills and then snort or inject the powder.
Police say OxyContin has become the drug of choice among addicts in far Southwest Virginia, where there have been more than 35 fatal overdoses and a wave of crime attributed to the drug. Part of the problem, according to law enforcement officials, is physicians who prescribe the drug too liberally.
The FDA is emphasizing that OxyContin "should not be used for temporary or occasional pain," spokeswoman Susan Cruzan said. "It shouldn't be prescribed to first-time patients who have some type of temporary pain who can use other types of medications."
Both the FDA and Purdue Pharma stressed that the latest warnings should not restrict the drug's availability to those who truly need it.
"We believe these changes to our package insert will further enhance our efforts to minimize abuse and diversion of OxyContin tablets, while continuing to ensure that legitimate patients continue to have access to this medication," Purdue Pharma CEO Michael Friedman said in a prepared statement.
Purdue Pharma said the latest warnings should not be construed as an effort to restrict OxyContin prescriptions. However, a statement posted on the FDA's Web site said the new labeling "is intended to change prescription practices" so that OxyContin is not dispensed inappropriately for "pain of lesser severity than the approved use."
The company said its original package insert contained essentially the same information that is included in the new material. The changes, which Purdue Pharma said were made voluntarily in cooperation with the FDA, reinforce warnings about the drug and place them in a more prominent position on the literature.
"Given the recent serious problem with abuse and diversion of the product in some areas of the country, the company believes it is appropriate to make these changes at this time," Friedman said.
A news release issued by Purdue Pharma on Wednesday stated that doctors are now being told that OxyContin should not be used in the following cases:
As a "prescribed as needed" analgesic;
For pain suffered within 12 to 24 hours after surgery;
And for pain that is mild or not expected to last for an extended period of time.
Legitimate uses of the drug include treatment for cancer patients and sufferers of severe, chronic pain.
Since the FDA approved OxyContin in 1995 for treatment "of moderate to severe pain where use of an opioid is appropriate for more than a few days," it has become Purdue Pharma's leading product, accounting for about 80 percent of the company's sales.
Last year, the company sold more than $1 billion worth of the drug.
Lawsuits filed by people who say they became addicted to the painkiller accuse Purdue Pharma of marketing the drug excessively to doctors while failing to provide adequate warnings about its potential for abuse. The company has called such claims baseless.
Purdue Pharma's new warning about the drug was welcomed by Strother Smith, an Abingdon attorney who has filed a $5.2 billion lawsuit in Lee County on behalf of five people who said they became addicted to the drug.
"Some people might be tempted to say: 'Too little, too late,'" Smith said. "Unfortunately, a tremendous amount of damage has already been done."
