What the hey, FDA?

Late February, a new drug known as Zohydro was approved by the FDA and is expected to hit the market later this month.

Zohydro is a hydrocodone bitartrate, also known as an opiod. You’ve probably taken it in the form of Lortab, Norco, Vicodin, etc., if you’ve had, say, wisdom tooth surgery.
But there’s a key difference in Zohydro that distinguishes it from those other drugs — the absence of acetaminophen, also known as Tylenol.

This is important because acetaminophen in these combination opiods allows for less hydrocodone to be present in the pill and, most importantly, discourages abuse. Acetaminophen will ruin your liver if taken in high doses over an extended period of time.

If you’ve taken any opiod, you also probably know that the effects feel pretty damn good. This causes abuse, and dependence can occur rather rapidly. The approval of Zohydro by the FDA concerns critics in the medical field.Zohydro is an extended-release capsule that can be up to 10 times as potent as Vicodin and those other drugs.

The capsules are meant to deliver around-the-clock relief like OxyContin. But what has everyone most worried is the capsule can be easily crushed for insufflation, unlike OxyContin. The highest dose of Zohydro is 50 milligrams, five to 10 times as potent as Vicodin, which contains five milligrams of hydrocodone and 325 milligrams of acetaminophen.

Crushing up one capsule and getting 50 milligrams of hydrocodone at one time will, for lack of a better phrase, knock you on your ass. This will, of course, cause every junkie in the country to line up for a taste. Inevitably, many will overdose.

And, sure, maybe you don’t care about junkies. But hopefully you care about children.

“This is now putting a new drug on the market where one pill could kill a child,” said Dr. Jim Keany of St. Joseph’s Hospital in Orange County, Calif. In the past 15 years, prescriptions for opiod painkillers have skyrocketed.

This increase in prescriptions has caused an equally-as-huge increase in overdoses.
In the same time period, opiod overdose deaths increased by 415 percent in women and 265 percent in men. Doctors are overprescribing painkillers, simple as that.

Contrary to popular belief, most abusers don’t get these drugs from dealers. A recent government study revealed that as low as 15 percent of opiod abusers actually purchase them from dealers.

According to the study, about 25 percent of abusers doctor shop, meaning they hunt down multiple doctors to write prescriptions. Another 25 percent get the pills for free from friends and family.

So the fact of the matter is: we don’t need another opiod painkiller on the market.
Especially one with the potential, rather, the inevitability, to be as dangerous as Zohydro.

­ziperr@indiana.edu