NewsMax.com Wires
Friday, July 27, 2001

FDA's Dr. Cynthia McCormick told United Press International on Thursday that the decision to require Purdue Pharmaceuticals of Stamford, Conn., to place a "black box" warning label on OxyContin was the most stringent action the agency can take.

"This is what's within our authority," said McCormick, director of FDA's division of Addictive Drug Products. "The sponsor came to us, and we conceived a plan. We agreed early on that the labeling had to be strengthened."

FDA also is requiring Purdue to issue "Dear Doctor" letters to physicians warning them of reported abuse problems with the drug.

Numerous reports of OxyContin diversion and abuse have been reported. The first reports included overdoses, deaths and robberies in Kentucky, West Virginia, Virginia, Tennessee and Maine, and there is increasing concern in cities on the East Coast and elsewhere.

Like morphine, the drug has a high potential for abuse. It is supplied in a controlled-release dosage form and is intended to provide up to 12 hours of relief from moderate to severe pain. Abusers of the drug crush it and either inhale the powder or inject it to produce a heroin-like high that lasts for up to 12 hours.

OxyContin is a controlled substance in Schedule II of the Controlled Substances Act, which provides the maximum control possible for approved drug products. The Drug Enforcement Administration can, however, decide to place a drug on Schedule 1 of the CSA, making it entirely illegal.

McCormick said she was aware of only two drugs in the past that have been withdrawn: hypnotic drug Quaalude or methaqualone and the pain killer Talwin or pentazocine hydrochloride, which was withdrawn almost 15 years ago but reapproved shortly thereafter in a reformulated analgesic version containing aspirin. In the United States, the marketing of methaqualone products stopped in 1984 when it was made an illegal substance under the CSA.

"With OxyContin there is very similar potential for abuse," McCormick said. "We're very concerned about the reports of drug and criminal activity."

She said that while the FDA does not make drug decisions based on requests from law enforcement agencies, it has been collaborating with the DEA and others, as well as with Purdue, to work through the growing OxyContin problem.

The agency, together with the manufacturer, next will launch an educational campaign carrying a "strong message" about the drug's dangers and further alert physicians to the potential for diversion and abuse, she said.

FDA continues to recommend that appropriate pain control be provided to patients who are living with severe pain, McCormick said. "This is a very valuable agent for the population of patients living with chronic, severe pain, those who need pain relief around the clock," she said. "But we have reason to believe patients are not getting it for chronic pain."

Attention also must be paid to those people who become addicted or dependent on OxyContin, legally or not, she told UPI. "It's important to remember that these people need help, too."

Purdue Pharmaceuticals did not return UPI's phone calls.

Copyright 2001 by United Press International.

All rights reserved.

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