WASHINGTON (CBSDC) – On Wednesday, the U.S. Food and Drug Administration announced that they plan to implement labeling changes on prescription opioids for the sake of safety.
“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,” Margaret A. Hamburg, the FDA Commissioner, was quoted as saying in a press release.
She added, “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.”
The new labels will make use of what the FDA referred to as “important new language” in order to prevent misuse by patients, with emphasis placed on those who are pregnant – the FDA asserts that use of opioids during pregnancy could result in neonatal opioid withdrawal syndrome, which could come with side effects such as rapid breathing, excessive crying and trembling.
The FDA additionally cited risk of abuse as cause to assert that opioids should only be prescribed when other treatments were ineffective in treating a patient.