Women… If you haven’t seen the latest news about Ambien, brace yourselves. And if you think you’re safe just because you’ve never taken Ambien? Think again.
Last year, the FDA issued a revised dosage of the popular sleep drug—one of the most popular on the market—for women only.1 Their research found that women had nearly 50 percent more of the drug in their systems than men taking the same dosage. And talk about scary…
Ambien can cause black outs, reckless driving, even cases of murder have been reported.2 Needless to say, this isn’t a drug you want excessive amounts of in your body (or really at all). Even more shocking? The FDA knew about this risk to women over 20 years ago.3 But that’s still not even the worst part…not by a long shot.
Historically, men have been the primary subjects in drug studies. Not just Ambien. We’re talking about pretty much ALL drugs. So what’s the big deal?
As we can see from the results of re-evaluating Ambien, men and women metabolize drugs differently. Even though drugs may work equally between the sexes to manage a disease, the severity of side effects can be completely different.4
Experts like Dr. Larry Cahill say that this calls for the full reevaluation of all FDA-approved prescription drugs. But the FDA says that’s simply too big an undertaking.5
|Even in animal studies, the subjects are usually male. This means a potentially dangerous side effect to females may not even surface until a drug makes it to human trials.|
Too big an undertaking? When millions of lives are on the line? And we’re not being dramatic when we say that.
Consider this 2001 report by the Government Accountability Office (GAO). It found that 80 percent of the drugs taken off the market between 1997 and 2001 were a greater threat to women than men. 80 percent!
In October of 1992, they urged the FDA to ensure closer study of gender differences in drug testing. This came after finding that women were either grossly underrepresented or completely absent from Big Pharma’s clinical drug testing. The result? The FDA put new policies into place for including women in drug development the following year. 6
So, the FDA’s solution was to include women in the testing. But guess what? They then chose to ignore the results of the tests.
If a drug trial uses 50 men and 50 women, researchers don’t report the gender breakdown. They note it as 100 total subjects. So if a drug causes an adverse reaction in 10 of these subjects, it doesn’t seem like a big deal. Yet it’s possible that every subject in that group is female. That would be a very big deal.
Make no mistake, this could change everything we know about prescription drug addiction and overdose.
Prescription drug abuse is more common in men. Or so everyone thought. But consider a drug, like Ambien, that is 50 percent stronger in women than in men. Women don’t have to take nearly as much for it to be considered abuse or addiction. On the surface, because gender is ignored, it doesn’t seem dangerous.
Apparently the FDA doesn’t have the time or patience to help save lives. They won’t even review all the drugs in the same class as Ambien. And let’s face it; there is simply no way that Ambien is the only drug that affects men and women differently. This raises questions about what other drugs out there—antidepressants, painkillers, cardiac—women are taking too much of without ever knowing.
Ignoring these differences to get drugs on the market faster is more than irresponsible. It’s dangerous and borderline criminal.
So what can you do? As you know, we recommend avoiding prescription drugs whenever possible. If you don’t take them in the first place, you don’t have to worry about dosages. It’s the only real way to sidestep this danger—especially since it looks like the FDA is going to do about what we’d expect. Nothing.
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