FDA Approval Of Zohydro Mystifies And Concerns Many

The United States is awash in opioid painkillers with addiction rampant. Since 1999 prescriptions for opioids have tripled and the number of opioid-related deaths have quadrupled, with legally prescribed medications now accounting for 60 percent of drug overdoses. There are five million Americans currently addicted to opioids, and three out of four overdose fatalities are caused by opioids. So do we really need another opioid medication? Do the benefits outweigh the risks?

What Is Zohydro?

A new opioid called Zohydro, approved by the Food and Drug Administration (FDA) in late 2013, is Hydrocodone with an extended, 12 hour release formula. For comparison, the painkiller Vicodin is Hydrocodone with acetaminophen. Zohydro has no acetaminophen – it’s unadulterated Hydrocodone that has been described as five or 10 times stronger than Vicodin. A single tablet could kill a child, and two pills could be enough to kill an older person unaccustomed to opioids.

Additionally, the pills are not crush or addiction resistant. As the opioid epidemic grew, many manufacturers reformulated their pills in order to make them more difficult to abuse. One way to achieve this is to add certain ingredients to the pills which cause unpleasant side effects if they are crushed and snorted or injected. Those side effects are not present when the drugs are taken orally as prescribed. People addicted to opioids often snort or inject them in order to get a fast and intense high.

FDA Approval Of Zohydro

However, the FDA decided to approve Zohydro with none of these precautions in place. A loud outcry from doctors, congressmen, pharmacists, lawyers, addiction specialists and state Attorneys General followed. All of these and more have asked the FDA to reconsider its decision to approve the potent new drug. Add to the list the FDA’s own advisory panel which voted overwhelmingly (11-2) to withhold approval of Zohydro.

A group of experts has written a forceful letter to the FDA urging it to rethink its decision to approve Zohydro. The addiction risk is simply too overpowering, the experts explain.

A look at the benefits gained versus risks imposed lead experts to say this should be enough to halt the drug’s release. We already know it‘s impossible to keep drugs in the hands of pharmacists, physicians and legitimate patients. A certain amount will inevitably be diverted toward un-prescribed and illicit use. And that, in turn, will mean a surge in opioid addiction.

Experts agree that the more opioid pills available in the country, the greater the risks for addiction. So one would expect approval of new opioids to be very hard to come by, which is what makes the Zohydro case so very perplexing.

There is an already a climate of opioid abuse. Opioids without tamper-resistant formulas or addiction-resistant formulas are ripe for abuse. And important voices from every direction are crying “Stop!”

Read About Understanding Opioid Related Disorders