WASHINGTON (Reuters Health) Jul 25 -The label of Purdue Pharma's OxyContin (oxycodone), a widely abused prescription pain medication, will carry strengthened warnings intended to help prevent inappropriate prescriptions, misuse and diversion.
Abusers of OxyContin often crush pills and snort them or dissolve and inject them to circumvent the drug's controlled-release delivery system. In a report released earlier this year, the Justice Department attributed at least 37 deaths to OxyContin abuse.
In light of the dangers associated with misuse of OxyContin, the US Food and Drug Administration (FDA) said on Wednesday that it has worked with Purdue Pharma to make several changes to the drug's label, including the addition of a black box warning, the strongest type of warning carried by prescription drugs.
Purdue Pharma will send a "Dear Healthcare Professional" letter to pharmacists, doctors and other healthcare professionals to stress the problems of abuse and diversion associated with the drug and explain the labeling changes.
"The new warnings are intended to lessen the chance that OxyContin will be prescribed inappropriately for pain of lesser severity than the approved use or for other disorders or conditions inappropriate for a Schedule II narcotic," the FDA said. An important consideration in making prescribing decisions is "the severity of the pain that is being treated, not simply the disease causing the painful symptoms," the agency added.
OxyContin is an opioid agonist that is about as addictive as its close cousin morphine, according to the agency. The drug is approved for patients with moderate to severe pain who are expected to need medication for an extended period of time.
Because all opioid blocking medications are subject to abuse, misuse and diversion, the FDA is also encouraging other manufacturers of the products to review and possibly revise their drug labels. The agency stressed that there is still a place for appropriate use of pain medications for patients who truly need them.
A Purdue Pharma spokesman told Reuters Health that the company is "pleased to be the first analgesic maker to make these changes" to product labeling. Other makers of opioid agonists include Johnson & Johnson and GlaxoSmithKline.
The spokesman downplayed the scope of the changes made to the OxyContin label, calling them "more of an exercise in graphic design" than an overhaul of content.
Purdue Pharma officials have pointed out in the past that in clinical trials of more than 6,000 patients, no subjects developed addiction to OxyContin. According to the company, legitimate users do not experience the high created by abusers who snort or inject the drug. The spokesman noted on Wednesday that the company has taken a number of steps to prevent diversion of OxyContin, including a $50 million effort to develop tamper-proof prescription pads.
In May, Purdue Pharma announced that
it was suspending distribution of 160-mg OxyContin tablets — the highest
dosage form — in order to help combat the abuse problem. But the following
month, a plaintiffs group in Washington, DC, filed a $5.2 billion lawsuit
against the firm and marketing partner Abbott Laboratories charging them
with aggressively marketing OxyContin without providing sufficient warnings
about the risks of misuse.
Copyright © 2001 Reuters Ltd
Copyright © 2001 Reuters Ltd