The Food and Drug Administration recently announced that class-wide safety labeling changes and post-market study requirements are being made for all extended-release and long-acting opioid pain medications.
The recent changes are being made after a growing number of individuals have been faced with the negative consequences of opioid analgesics for pain relief. There has been a great deal of misuse, abuse, addiction, overdose and death from these potent drugs, but many still ignore the dangers. While pain specialists and patients worry that the new requirements will limit their ability to get the medications they need, the FDA assures the public that these changes need to be made to protect the families and communities in our country.
Still, the FDA plans to balance patients in need of pain relief with the dangers of abuse, overdose and death. Among the changes, there will be a warning to doctors that opioid analgesics should only be prescribed to patients in severe pain who require around-the-clock, long-term treatment. Additionally, the drugs should be reserved for those who have not responded to other forms of medicine or therapy.
Another update being executed by the FDA is a label directed at pregnant women. The warning label will state that the chronic use of opioids by pregnant women may cause a life-threatening complication in their babies called neonatal opioid withdrawal syndrome. What happens is that the newborn goes through withdrawal because they are no longer exposed to the opioid.
The FDA is also demanding more boxed warnings about the dangers of pain medications, including the risk of addiction, overdose and abuse. With more attention toward the dangers of opioid pain medication, manufacturers will need to conduct more studies to be able to say anything differently. It’s a step in the right direction that raises awareness about the dangers of drug use for chronic pain relief.Share This: