Amid increasing rates of misuse and overdose deaths that result from opioids, the Food and Drug Administration (FDA) announced their plan to adjust warning labels on Tuesday, according to The Washington Post.
The FDA said their new warning labels will appear on all extended-release and long-acting opioid painkillers, such as Oxycodone, which is the most commonly used.
"The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the crisis of misuse, abuse, addiction, overdose, and death from these potent drugs that have harmed too many patients and devastated too many families and communities," said Margaret A. Hamburg, FDA Commissioner. "Today's action demonstrates the FDA's resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain."
While Hamburg declared the increasing rates of opioid addiction as a serious public health challenge, she emphasized the importance they have to people who are truly suffering in pain.
"We must also recognize the medical value they have for many patients living with pain. Therefore, the agency must strike a balance between their benefit in treating patients with pain and the risks associated with misuse, abuse, addiction, overdose and death," she said.
Although doctors used to prescribe the painkiller medication to patients in acute pain, such as cancer patients, prescriptions for the drugs have shot up -- partially due to the downplay of their side effects and risks.
Douglas Throckmorton, deputy director for regulatory programs in the FDA's center for Drug Evaluation and Research, explained how the new labels will help curb addition rates.
"These labeling changes describe more clearly the risks and safety concerns associated with ER/LA opioids and will encourage better, more appropriate, prescribing, monitoring and patient counseling practices involving these drugs," Throckmorton said.
The amount of addictions to painkillers have risen to epidemic levels. In 2009, a survey found that 2 million Americans were addicted to painkillers and the National Institute on Drug Abuse estimates that it costs the U.S. $193 billion per year.
