The U.S. Food and Drug Administration (FDA) recently ordered label changes
for extended-release and long-acting opioid pain relievers. The changes
are intended to encourage better prescribing habits by doctors and curb
abuse among patients.
Opioids are largely responsible for a surge in prescription drug overdoses
in recent years. Drug poisoning is now the leading cause of death from
injuries in the United States.
During the most recent decade, the number of drug deaths involving opioid
analgesics more than tripled from about 4,000 in 1999 to 14,800 in 2008.
To further compound the problem, recent reports also suggest that doctors
in California and across the country are increasingly handing out prescriptions
for potent opioids like morphine and Oxycodone with little concern for
patient safety, often leading to serious addiction problems and death.
FDA labeling requirements reflect the risks of both negligent prescribing and patient abuse. They
emphasize that other, less potentially addictive, treatment options should
be considered first.
New labels must state: “Because of the risks of addiction, abuse
and misuse with opioids, even at recommended doses, and because of the
greater risks of overdose and death with extended-release opioid formulations,
reserve [Tradename] for use in patients for whom alternative treatment
options (e.g., non-opioid analgesics or immediate-release opioids) are
ineffective, not tolerated, or would be otherwise inadequate to provide
sufficient management of pain.”
In addition to the labeling changes, the FDA will also require drug companies
to conduct longer-term studies and trials of extended-release and long-acting
opioid pain relievers on the market. According to the agency, the companies
must “evaluate long-term use, with the goal of assessing a variety
of known serious risks, including misuse, abuse, addiction, overdose,
and death, as well as the risks of developing increasing sensitivity to