More than 40 medical experts wrote a letter to the Food and Drug Administration asking them to reconsider approval recently given to a painkiller called Zohydro, a hydrocodone formulation that’s up to 10 times stronger than Vicodin.
Against the recommendation of an advisory panel, which voted 11 to 2 against approving Zohydro, the FDA approved the drug in October. It’s expected to hit pharmacy shelves next month.
Experts say just two Zohydro pills can be fatal.
Unlike Vicodin, which contains acetaminophen, Zohydro doesn’t contain the nonsteroidal anti-inflammatory drug. It’s a pure narcotic, like OxyContin. Addicts will be able to load up on the painkiller without fear of liver damage.
“In the midst of a severe drug addiction epidemic fueled by overprescribing of opioids, the very last thing the county needs in a new, dangerous, high-dose opioid,” says the letter signed by 42 medical experts.
“Over the past 15 years, prescriptions for opioids have skyrocketed. The United States, with about 5 percent of the world’ population, is now consuming more than 84 percent of the world’s entire oxycodone supply and more than 99 percent of the hydrocodone supply,” they wrote.
“Zohydro is not safer,” the letter says. “The highest available dosage of Zohydro will contain 5 to 10 times more hydrocodone than Vicodin or Lortab. Someone unaccustomed to taking opioids could suffer a fatal overdose from just two capsules. A single capsule could be fatal if swallowed by a child.”
"It's a whopping dose of hydrocodone packed in an easy-to-crush capsule. It will kill people as soon as it's released," said one of those experts.
But one doctor argues, "it all depends on how doctors monitor it. It could be lifesaving. But if used the wrong way, like any medication, it can cause trouble."