Off-label prescribing can be a prescription for disaster

Woody Witczak was 37 when his doctor gave him an Rx for the antidepressant Zoloft.

Five weeks later, he was dead. He had hung himself from the rafters in his garage.

Woody didn’t go to his doctor because he was depressed — he was having trouble sleeping.

But Woody, and millions of others, are a part of Big Pharma’s longest-running experiment called “off-label prescribing.”

Off-label is such a financial windfall for drugmakers that they never want it to end. Actually, they want the FDA to give them even more ways to sell their drugs for conditions they were never tested for or approved to treat.

And it’s a risk you – and especially your kids and grandkids — take every time you fill a prescription.


‘The perfect storm’

Big Pharma would be thrilled if the FDA disappeared tomorrow. And most of the time it acts as if it has!

Over the years it has paid billions in fines when it’s caught giving doctors the sales pitch on all kinds of different – and unapproved — ways they can use its drugs.

You see, while doctors can write an Rx for any drug for any reason, drugmakers are supposed to only promote them for FDA-approved conditions.

However, off-label prescribing is so common, that for adults, one in five prescriptions aren’t for approved uses. For kids, it’s a whopping 90 percent.

And it’s a secret usually discovered only when things go terribly wrong.

Now, you would think Big Pharma would be happy with how things are going. It pretty much does exactly what it wants to, and every now and then pays a fine.

Yeah, you would think.

However during a big FDA meeting held a few weeks ago about using meds off-label, drugmakers made it perfectly clear that they would prefer all the restrictions be lifted.

“Manufacturers are the best experts on our own medicine,” said a Pfizer official.

But in this two-day session, Big Pharma finally got a taste of its own medicine.

Woody’s wife, Kim Witczak, testified. So did Steven Francesco, who told through tears how his 15-year-old son Andrew died after being given the drug Seroquel off-label.

As Francesco describes it, Andrew was fine on Friday, and in a “vegetative state on Sunday” that he never came out of. He calls off-label prescribing the “Wild West.”

Witczak told the large audience at FDA headquarters (which included agency officials) that the average person has no idea what off-label even means, and automatically assume a drug is FDA approved. “It’s the perfect storm,” she said.

And that’s exactly what it is.

So many meds are given out for so many off-label uses by now that plenty of doctors probably don’t even realize they’re doing it.
For example, numerous heavy-duty psychiatric drugs are prescribed for insomnia (like in Woody’s case), pain and hot flashes. Drugs approved for epilepsy are given to treat irritability. Namenda, a med that the FDA approved for Alzheimer’s patients, is used off-label in kids with obsessive compulsive disorder. Malaria drugs are being given for restless leg syndrome!

It’s simply outrageous.

And recent studies have found that your chances of suffering a side effect from taking a med off-label shoot up by a giant 50 percent.

That’s why before taking any Rx from your doctor you should ask him if the drug is being prescribed off-label. Find out what the med was actually approved for and why he thinks it will help your condition.

Many grieving family members wish their loved ones had done that. Only now it’s too late.

“FDA spotlights unapproved use of drugs, medical devices” Jen Chrlstensen, November 14, 2016, CNN, cnn.com