FDA Strengthens Its OxyContin Warnings
Doctors and pharmacists were urged Wednesday to restrict the prescription painkiller OxyContin to patients with serious pain, as the government strengthened warnings that improper use of the pills can cause addiction and kill.
The actions by the Food and Drug Administration and OxyContin maker Purdue Pharma of Stamford, Conn., are an attempt to stem illegal use of the painkiller, which has been cited in increasing reports of addiction, emergency room visits and overdose deaths.
OxyContin is a long-lasting version of oxycodone, a narcotic considered important therapy for many patients suffering long-term and moderate to severe pain from cancer or other illnesses, the FDA stressed. When swallowed whole, the tablet provides 12 hours of pain relief.
But if chewed, snorted or injected, OxyContin produces a quick, and potentially lethal, high. It has been linked to more than 100 deaths since 1998.
Drug abusers don’t read warning labels. But the hope is that if doctors give OxyContin just to patients with serious, chronic pain, it will become harder for abusers to get leftover tablets.
“We’re hoping . . . people will consider this a serious drug for serious pain,” said Dr. Cynthia McCormick, the FDA’s chief of addictive products.
OxyContin will bear the FDA’s strongest type of warning--a black box calling OxyContin as potentially addictive as morphine and explaining that chewing, snorting or injecting it can kill, she said.
It is not for mild pain or for temporary pain, such as after dental or surgical procedures.
Purdue wrote 800,000 doctors about the warnings. Also, the FDA posted a patient information Web site, https://https://www.fda.gov/cder/drug/infopage/oxycontin, urging that OxyContin be kept in a secure location and that unneeded tablets be flushed down the toilet.
OxyContin is intended to be swallowed whole. If crushed, injected or inhaled through the nose, the controlled-release mechanism does not work and a potentially lethal dose is administered, the FDA said.
In May, Purdue Pharma suspended shipment of 160-milligram tablets, the strongest dose, saying it was “concerned about the possibility of illicit use of tablets of such high strength.”
Reports of misuse have led to legal action in Virginia, West Virginia and Kentucky.
In June, the drug’s makers and promotion partner Abbott Laboratories were named in a $5.2-billion lawsuit that claims they failed to warn patients the drug might be dangerously addictive.
