FDA, Maker Warn Doctors on OxyContin
July 25, 2001 — -- The Food and Drug Administration is beefing up warning labels for doctors prescribing the controversial prescription pain medication OxyContin.
In a "black box warning," the strongest type of warning for an FDA-approved drug, the agency is telling doctors not to prescribe the narcotic with addictive properties similar to morphine except for patients with the most severe, continuous pain.
OxyContin "can be abused in a manner similar to other opioid agonists [drugs of its type], legal or illicit," reads the new warning, announced today. "This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion" to illegal distribution channels.
The stern warning comes amid continuing reports of abuse and overdose deaths linked to the drug.
The six-paragraph warning appears at the top of an insert in OxyContin packaging sent to doctors and pharmacists who dispense the drug. A spokesman for Purdue Pharma, the maker of OxyContin, said the warning amounts to a stronger, briefer and more direct restatement of technical information previously contained within the drug's lengthy product labeling, but possibly missed by some doctors.
Purdue Pharma also has sent 800,000 copies of a letter explaining the labeling changes and risks of improper OxyContin use to health-care professionals.
"It is a cooperative effort" between the FDA and Purdue Pharma, said Robin Hogan, executive director of public affairs for the Stanford, Conn.-based company. "It's bad business to have these pills misprescribed, misused, overprescribed. … The FDA feels that in some cases this is happening and this is an effort to prevent that."
The opiate acts on the same receptors in the brain as heroin and is prescribed for moderate to high pain relief. Percocet, Percodan, and Tylox are other trade name oxycodone products. But OxyContin is the longest lasting oxycodone product on the market, acting for 12 hours.
