FDA’s Approval of Hydrocodone-Only Drugs Causes Concern

by AddictionCenter |

Recent FDA Rules Around Hydrocodone Could Lead to Addiction

In light of recent scandals among U.S. officials taking advantage of their positions, those in the addiction recovery community are left to wonder whether other authority figures should also be called under scrutiny.

Last year, in response to approval of a hydrocodone-only product known as Zohydro, activists called for the resignation of FDA Commissioner Dr. Margaret Hamburg. Hydrocodone is a potent opioid and main ingredient in drugs such as Vicodin and Norco. These drugs combine hydrocodone with other ingredients, such as ibuprofen or acetaminophen.

By eliminating the buffer of other ingredients, hydrocodone-only products have the potential to be more dangerous and more likely to be abused.

Zohydro has up to 5 to 10 times more hydrocodone than Vicodin.

The FDA approved the drug despite objections from both its medical advisers and the CDC, causing many industry professionals to question the organization’s motives.

Leaders within the FDA have said they want to approve these drugs to help those suffering from extreme chronic pain, which can’t be managed with painkillers currently on the market.

However, the possibility for addiction to these types of drugs is higher than ever.

Part of the reason outcry over Zohydro’s approval was so strong was because the drug doesn’t have abuse-deterrent properties in place. Zohydro is an extended-release hydrocodone formula meant to be taken orally twice a day. Abusers can easily crush up and snort the drug for faster, stronger results.

OxyContin, an extended-release formula of opioid oxycodone, faced the same problems and opposition when it released years ago. Due to increased pressure from anti-addiction activists, the drug was later reformulated to prevent abuse.

Another pure hydrocodone drug, known as Hysingla, was also recently approved by the FDA. Hysingla is long-acting, designed for users to take it once a day for chronic pain. Unlike Zohydro, Hysingla was intentionally designed to prevent abuse—though the FDA noted abuse is possible, and overdose is always a concern with potent painkillers.

These drugs are more potent than hydrocodone-combination products such as Vicodin. They are also less damaging to the liver when taken in high amounts, something creators of the drug see as a positive thing. However, some abusers of the drug may have the dangerous perception that this means the drugs are safe, even in high amounts.

One addict said this: “The only thing that was standing in the way of more pills was the fear I was gonna mess up my liver.”

The facts are hard to ignore. An estimated 2.1 million people in the United States suffer from substance use disorders related to prescription opioid pain relievers. Nearly 17,000 Americans die every year because of opioid overdoses.

Zohydro, Hysingla and hydrocodone-products are regulated by the government. Hydrocodone-combination products were recently changed to Schedule II drugs, meaning there are tighter restrictions in terms of access. No hydrocodone products can be automatically refilled without revisiting a doctor, for example.

This monitoring hasn’t seemed to do much to keep the rate of abuse or addiction down. It is estimated that 26.4 million to 34 million people struggle with an opioid addiction, and Americans consume approximately 80 percent of the world’s opioids.

If you or someone you know is among those struggling with an opioid addiction, find a treatment center that can help you break the cycle.

Sign-up for our newsletter

Vital perspectives on fighting addiction delivered straight to your inbox.

    What does it mean that this site is brought to you by Beach House Center for Recovery?

    We strive to be fully transparent in all of our relationships. To that end, we want you to be aware that AddictionCenter is compensated by Beach House Center for Recovery for the work AddictionCenter does in the development and operation of this site. Beach House Center for Recovery was carefully vetted and selected to be a trusted provider and partner with AddictionCenter, based on the quality of treatment that Beach House provides and their rigorous commitment to ethical practices. Learn more about why Beach House Center for Recovery is a trusted provider with AddictionCenter.

    All calls to numbers on individual facility listings will always go to the facility listed. All calls to general contact numbers and contact us forms on this site are routed to Beach House Center for Recovery. If Beach House Center for Recovery is unable to assist with a particular need they are committed to providing direction and assistance in finding appropriate care.

    Get 24/7 help now. All calls free and confidential.

    (855) 826-4464

    Take control of your life

    Our treatment specialists offer 24/7 assistance.

    • Access to top treatment centers
    • Caring, supportive guidance
    • Financial assistance options

    Call now:

    (855) 826-4464

    OR

    Have us call you:

    (877) 746-0480

      Where do calls go?

      Calls to numbers dedicated to a specific treatment center profile will be routed to that treatment center. All other calls will be routed to Beach House Center for Recovery.

      Rehab experts are available 24/7/365 to answer and return calls routed to Beach House.

      All calls are private and confidential.

      How do we choose our partners?

      About Beach House

      Beach House Center for Recovery is a leading drug and alcohol treatment center that combines the latest medical, clinical, and spiritual treatments to combat addiction.

      Find out more about AddictionCenter.

      A treatment facility paid to have their center promoted here. Learn more about how to be featured in a paid listing.