Beware using drugs “off-label.” You’ll be in uncharted waters — and on your own

Warning (off) label

Right now, you might be playing a game you don’t even know about…and it could be putting you at serious risk.

It’s a dirty little game called “off-label usage.”

It sounds innocent enough, but it is anything but.

You see, once the FDA approves a drug, doctors are free to use their own judgment in how they’ll prescribe the drug.

Now, drug companies can’t promote a drug for any disease it isn’t approved to treat. Of course, they do it anyway. It just happens behind closed doors when drug reps pitch drugs to doctors, one on one.

And it’s happening a LOT more than you’d think. In fact, off-label usage accounts for 20 percent of the prescriptions written in the U.S.!

Off-their-rockers

In some cases, it might work. But in other cases it is just downright dangerous. The problem is you have no way of knowing.

Here’s one of the most egregious examples of ignoring off-label risks I’ve ever seen. And it targets two of our most vulnerable populations…new moms and infants.

Two drugs — Reglan and Domperidone — ease gas pains. But as a side effect, they happen to promote lactation. That might be annoying if you have a gas problem. But a little help with lactation can be appealing to new mothers who struggle with breastfeeding.

But Reglan side effects include depression, fatigue, and irritability. You can put those right at the top of the list of things a new mom does NOT need.

Now Domperidone makes Reglan look like Smarties. Side effects from Domperidone include hot flashes, breast pain, headaches, eye pain, and eye swelling.

Again, just what a sleep-deprived, hormonal, new mother needs.

Still, it gets worse — and much more dangerous — for the baby.

You see, the body excretes the drug in breast milk. That’s why the FDA warns that the drug could expose an infant to “serious adverse effects.”

In this one instance, the agency has taken a stand. It won’t approve Domperidone for any use in the U.S.

Unfortunately, confused, desperate mothers can still get it pretty easily. It’s available in Canada, and from dubious sources on the Internet. And in spite of all the potential dangers, some lactose consultants actually recommend these drugs.

Unbelievable!

Breastfeeding is clearly the best way to feed newborns. But encouraging vulnerable young moms to take these risky drugs is, well…let’s call it what it is… malpractice.

This is just one example of off-label usage gone wrong…very wrong.

I’m not a fan for ON-label usage of most drugs, but this takes drug dangers and misinformation to a whole new level. So if your doctor prescribes a drug, always check to see if it’s approved for your condition before you swallow a single pill.

Sources:
“Breastfeeding Pills’ Risky Results” Eliza Shapiro, The Daily Beast, 8/7/12, thedailybeast.com