Dr. Henry Paul, MD

Psychiatrist, Author and Educator

BLACK BOX WARNING ON PAINKILLERS

March 25th, 2016

“They’re the most powerful painkillers ever invented, and their creating the worst addiction crisis America has ever seen.” TIME Magazine Cover June 2015

6422127_sThe US Food and Drug Administration this week announced that painkillers, such as OxyContin and Fentanyl, will now have to carry a “black box” warning stating the dangers of abuse, addiction, overdose and death.

It is called a black box warning because that is how it appears – in a black box. According to the FDA website, “it appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.”

The FDA hopes that this warning will help to slow a growing epidemic in this country of opioid addiction that is leading to heroin addiction, overdose and death. In 2015, TIME magazine reported in their cover story that “9.4 million Americans take opioids for long-term pain and 2.1 million are estimated by the NIH (National Institutes of Health) to be hooked.”

The article went on to say that the crisis is a “tragic combination of good intentions, criminal deception and feckless oversight to turn America’s desire to relieve its pain into such widespread suffering.”

Here’s what the FDA told CNN about how this warning will work. “When a patient gets his or her prescription filled, the bottle should have a notification indicating there is a black-box warning for the drug. The consumer would need to go to the manufacturer’s website for details. In addition, pharmacists are encouraged to provide patients with a medication guide — consumer-friendly language explaining the risks of the drug. Under this new effort from the FDA, all instant-release drugs will need to have such a guide. It is up to the pharmacist to dispense this information, something the FDA encourages.”

The FDA ruling is a long-overdue step toward fighting America’s drug epidemic. I’m not sure it is realistic to assume that consumers will go to the manufacturers website for details, but I do think that pharmacists taking the time to go over the risks of painkillers will help. I have to agree with Senator Markey in what he told CNN, “It’s too little, too late.” We have a long way to go to turn this epidemic around and educating the public and doctors is key.

LINKS
Time Magazine Releases Cover Story on Pain Killers
Physicians for Responsible Opioid Prescribing
FDA now requires ‘black box’ warning on painkillers

DISCLAIMER
Information contained in this blog is intended for educational purposes only. It is not intended as medical or psychiatric advice for individual conditions or treatment and does not substitute for a medical or psychiatric examination. A psychiatrist must make a determination about any treatment or prescription.


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