FDA to Require "Black Box" Label on Addictive Opioid Medications | Harbor Village - Harbor Village

FDA to Require “Black Box” Label on Addictive Opioid Medications

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After months of debate and resistance from medical professionals and Big Pharma, the FDA has made a final decision: pharmaceutical companies are now required to add a ‘black box’ label to their powerful, addictive opioid medications. This comes just as the CDC published new guidelines for prescribing these medications for doctors, suggesting use of drugs like ibuprofen before turning to the stronger painkillers.

One major problem that has helped catapult the prescription drug abuse epidemic is that opioid drugs are often touted as being useful for everyday aches as well as major pain management without being addictive. We know now, of course, that those claims are flawed; so much so, that it costs thousands their lives every year.

Here’s some quick facts:

  • Heroin, one of the big three illicit and illegal substances claiming lives, was invented as an alternative to morphine, which was widely abused at the time. While it quickly became clear to doctors that heroin was highly addictive and deadly, it took decades for legislation to correct the problem of overexposure and easy access in stores and pharmacies.
  • Abuse of opioid medications often leads to heroin abuse, as they both work via the neuro-receptors of the nervous system.
  • New research supports the fact that addiction is a disease of the brain, showing that it causes physical and chemical changes in the brain.  

So what exact is required of Big Pharma through this new ruling? These new black labels, much like those required on cigarettes. Must warn about misuse, abuse, addiction and overdose. This is especially important for immediate release opioid medications which require use every four to six hours- some 90 percent of opioid meds fall into this category.

Interestingly enough, the FDA required these labels on extended-release painkillers back in 2013.

Details regarding the risks of using these opioid medications like OxyContin and Ritalin will be available on the manufacturer’s website; doctors are encouraged to provide their patients with information regarding their medications as well.

FDA Commissioner Dr. Robert Califf says,

“Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids. Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”

Additional Reading:

The Addicted Professional: What Employees and Bosses Need to Know

College Kids and Pills: The Epidemic Born from Perfectionism

Addiction: The Things Most People Get Wrong

What is Melodonium, the Drug Used By Tennis Star Maria Sharapova?

Fentanyl Sparks First-of-Its-Kind Lawsuit Between Companies

What other actions can the medical community take to prevent and reduce prescription medication abuse? Let us know what you think in the comments below!

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