FDA issues tougher warnings on opioid painkillers
In a move designed to stem the non-medical use of prescription drugs, the U.S. Food and Drug Administration (FDA) is taking steps to issue safety restrictions in response to a rapid spurt in fatalities resulting from their abuse.
Emergency room visits of those addicted to OxyContin and other powerful pain medications are becoming rampant in the nation. The dangerous trend is a cause for concern with the experts worrying over its adverse impact on public health.
The highest abused prescription pain drugs are opiads like morphine, oxycodone, and fentanyl, all of which showed statistically significant increase during the last decade. Statistics reveal that nearly16,651 people fell prey to an overdose of opioids including long-acting formulations in 2010.
“The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities,” stated FDA Commissioner Margaret Hamburg.
Guidelines issued by FDA
Given that the pain medications are extremely vital, some patients, the health regulators are trying to balance their availability with the hazards of drug abuse use.
Presently, drugs are recommended for “moderate to severe” pain. According to the new rules proposed by the FDA, opiads should be prescribed for patients enduring “pain severe enough to require daily, around-the-clock, long-term” treatment. Moreover, they should be reserved for patients who have exhausted all treatment options but found no relief.
Due to apprehensions pertaining to safety, manufacturers will be compelled to include prominent boxed warnings on drugs labels, indicating the dangers of death and the potential risks of opioid withdrawal syndrome to newborns of mothers abusing the drugs.
The agency is also urging the drug makers to conduct more research in order to assess the hazards tied to the use of opiads including addiction, abuse and lethal overdoses.
“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,” Hamburg said.