FDA’s Approval Of Hydrocodone-Only Drugs Causes Concern

Recent FDA Rules Around Hydrocodone Could Lead to Addiction

In 2014, in response to approval of a hydrocodone-only product known as Zohydro, activists called for the resignation of FDA Commissioner Dr. Margaret Hamburg. Leaders within the FDA have said they wanted to approve these drugs to help those suffering from extreme chronic pain, which can’t be managed with painkillers currently on the market. However, many are against this approval, as the addiction risk for these types of drugs is high.

Hydrocodone is a potent opioid and main ingredient in drugs such as Vicodin and Norco. Drugs like Zohydro 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.

Dangers Of Zohydro

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 person who struggled with addiction said: “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 2.5 million people in the United States suffer from substance use disorders related to prescription opioid pain relievers, and opioid-involved overdose deaths rose to 81,806 in 2022.

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.

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