FDA requires ‘black box’ warning on immediate release painkillers
| In an attempt to slow the prescription drug abuse epidemic, the U.S. Food and Drug Administration (FDA) announced Tuesday March 22, 2016 that immediate-release opioid painkillers such as oxycodone and fentanyl will now have a “black box” warning.
The warning will include information about the risk of abuse, addiction, overdose and death.
Prescription opioid painkillers are divided into two main classes:
1. Extended release, with more pain-killing opioid per dosage.
2. Immediate release, which have less opioids, but need to be taken more frequently.
Ninety percent of opioid prescriptions are for immediate-release painkillers, the FDA said. The “black box” warnings are the FDA’s strongest, and they’re meant to educate doctors as they’re prescribing medications to patients.
Opioid Warning Labels Required
Overdose deaths have been climbing for years and are now the leading cause of deaths from injuries in the United States. Three years ago, the FDA mandated a similar warning (known as a ‘black box’ warning), for the labels of long-acting opioid pain medications, such as OxyContin. Opioids are powerful pain-reducing medications that include morphine, hydrocodone and codeine.
Whether the new boxed warning on short-acting opioids will make much of a dent in what Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention, last week called a ‘doctor-driven prescription overdose epidemic‘ remains to be seen.
FDA also said it is requiring the addition of other new information in the “Warnings and Precautions” and “Adverse Reactions” sections on all opioid labels:
- Opioids can interact with certain antidepressants and migraine medications to cause serotonin syndrome, in which high levels of the chemical serotonin build up in the brain.
- Opioid use can lead to a rare but serious condition in which the adrenal glands don’t produce enough cortisol, a hormone that helps the body respond to stress.
- Long-term opioid use might be linked to decreased sex hormones, which can cause low sex drive, impotence and infertility.
Another black box warning could be in store for opioids
Health officials from 17 states and territories and 13 cities last month submitted a Citizen’s Petition to the FDA, asking that the agency require boxed warnings on opiods and benzodiazepines about the increased risk of a fatal overdose from combining the two types of drugs. Benzodiazepines are tranquilizers such as Valium and Xanax.
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Questions? Having Difficulty Quitting Prescription Painkillers or Battling Alcohol or Substance Abuse?
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