When you think of treatments for constipation, you think about adding more fiber to your diet, taking magnesium, and even OTC laxatives.
But I’m sure you would never – in a million years – think of taking a drug that’s in the same family as one used to induce abortions.
Yet that’s exactly what Amitiza is.
And you’ll never find that out by watching the new commercials for it that seem to be running all the time.
Because when the FDA was asked to make the warnings on the drug stronger in order to alert women who may become pregnant, not only did it refuse, but it did something else.
Something that’s hard to believe — even for the FDA.
A killer “cure”
You may have seen those new commercials for Amitiza. They show a woman twisting balloons, like a clown would do at a kid’s birthday party.
The balloons become a doctor, a dog (with a wagging tail), and finally a toilet. Sure is cute, alright.
But something critical is missing from those ads.
That something is a warning to women that they should make sure they aren’t pregnant before taking the drug. And that women should be very careful not to become pregnant while taking it.
That’s because Amitiza is in the same family as a well-known abortion drug called misoprostol. Misoprostol is so lethal to an unborn child, that taken alone, it will end a pregnancy 90 percent of the time.
And the FDA knows all about the danger.
So much so, that when Amitiza was first approved to treat constipation almost 10 years ago, those now-missing warnings were actually required.
But many thought that even those cautions weren’t enough. That the drug is so potentially dangerous to an unborn child that more needed to be done to warn women about the risk.
So the group Public Citizen filed a petition with the FDA, not only asking for a black box warning about the risk of killing your unborn child, but an alert to nursing mothers, a special guide for women and a warning letter to inform all doctors about this risk.
And a full 3 years later, the group finally heard back.
Not only did the FDA turn down every single warning Public Citizen asked for, it did something so shameful it almost looks like it was done out of spite.
On the very same day the FDA rejected those requests, it removed — that’s right – removed, several warnings to women it had previously required!
Like magic, an entire section on the drug’s label called “fetal risk potential” was no longer necessary. You can imagine that the drug companies that jointly market this med, Takeda and Sucampo Pharma, were pleased as punch.
After all, it must have been a real problem for them trying to market a drug for constipation that warns it can cause an abortion.
And even worse (if that’s possible), the FDA refused to require another very important warning. One that might protect innocent little babies from taking the drug — along with mom.
The concern is that Amitiza, like many drugs, can also be secreted in breast milk. Because of that mothers need to be warned not to take it while nursing. Infants could suffer serious adverse reactions, the petition said, such as diarrhea and nausea.
But the FDA turned that warning down, too. It didn’t think levels of the drug in breast milk would be high enough to cause “serious harm.”
Look, we all know that the FDA does next to nothing in its job of protecting us. But to think it would ignore the most basic (and critical) safety measures where precious babies are concerned is beyond belief.
“Petition requesting enhanced warnings on dangers of lubispostone (Amitiza)” Public Citizen, citizen.org