September 11, 2013
Opioid Painkillers To Get New Addiction-Warning Labels
Michael Harper for redOrbit.com - Your Universe Online
The FDA announced plans to change the way opioid painkillers will be labeled in an effort to sheer off climbing addiction numbers.
The new labels will emphasize the potential dangers of the drugs, particularly extended-release and long-acting varieties, while emphasizing that safer options should be considered before prescribing these drugs. Going beyond the labels, the FDA will also begin requiring drug manufacturers to do their own research to understand the long-term effects of these medicines and point out any serious risks.
A petition from an advocacy group called the Physicians for Responsible Opioid Prescribing prompted the new labeling changes.
Additionally, a recent study published in the journal The Lancet revealed such addictive painkillers are responsible for more than half of all the deaths from illegal drugs.
"The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications. They also are meant to reduce problems associated with their use," explained Douglas Throckmorton, MD, the deputy director of regulatory programs at the FDA. "Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them.”
Opioids such as morphine, oxycodone (the active ingredient in OxyContin) and fentanyl work by changing the way the brain perceives pain. This is potentially dangerous as the brain runs the risk of becoming dependent on these medications. According to the FDA, this is especially true of extended-release and long-acting versions of the drug which are more potent than other varieties.
The current labels on these opioids explain that the drugs are to be used for "the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time."
The new labels will encourage doctors and patients to find other options before using these drugs. According to the FDA, the new wordage will say the drugs are "indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate."
The labels will be designed to caution the patient about the addictive nature of the drug and suggest they only take the drug in the recommended doses.
“We recognize the importance of providing updated safety information about opioid drug products to healthcare professionals,” reads a statement from Purdue Pharma, the makers of OxyContin, as cited by the Washington Post. The pharmaceutical company began adjusting the formulation of the drug in 2010 to head off concerns about the addictive nature of the drug.
“The changes announced by the FDA today are part of that process. We are reviewing the labeling changes and requirements for additional studies outlined in the FDA letter and will respond to the FDA,” continues the statement.
The Physicians for Responsible Opioid Prescribing told The New York Times they were pleased with the new labeling changes, but hoped the agency would go even further by defining how much of the drug can be taken for how long.