FDA requires urgent labeling change on decades-old anti-seizure meds
Even ESTABLISHED drugs may not be as SAFE as you think! [New urgent warning]
Friend, you’ve surely learned by now that it takes A LOT to make the feds do ANYTHING.
They typically spend TOO LONG sitting on their hands… instead of INTERVENING when Big Pharma is churning out DANGEROUS drugs.
So when the FDA finally STEPS UP… and issues an URGENT warning…
You know it’s got to be BAD.
The latest has to do with anti-seizure meds… and a LIFE-THREATENING reaction that some folks may have to them.
Now, some seniors may be taking these drugs for epilepsy… but if you don’t have a seizure disorder, you’re not necessarily in the clear.
Because one of the drugs in question is a benzo that’s also prescribed for anxiety!
Here’s what you need to know about the potentially DEADLY dangers of these drugs…
And what to do if you’re already taking one.
They’re calling it a drug reaction with eosinophilia and systemic symptoms… or DRESS, for short.
But don’t be FOOLED by its cute name…
Because although you just may notice a MILD rash at first… without warning, your condition could take a NOSEDIVE…
And you could develop a fever and/or swollen lymph nodes.
Next, it could lead to internal organ injury… like the liver, kidneys, lungs, heart, or pancreas…
Or even death.
And now, the FDA is requiring drugmakers to slap a warning on the labels for the two drugs in question:
- levetiracetam
- clobazam.
Both have been around long enough that we SHOULD’VE known what all the risks were… with the first one having been approved in 1999 and the second one getting the green light in 2011 (and subsequently sometimes prescribed off-label for anxiety).
But this just goes to show how long it could take before we learn the TRUE dangers behind Big Pharma’s drugs.
Now, each of these two drugs is associated with a list of KNOWN side effects… but nothing as DRASTIC as what we’re hearing now.
DRESS didn’t show up in the original clinical trials…
And we might not have known about it, were it not for the reports filed in the FDA Adverse Event Reporting System (FAERS).
Problem is, reporting databases like that only give us a SLIVER of an idea of the ACTUAL scope of harm that’s out there… since adverse events (and even deaths) are largely UNDERREPORTED when it comes to drugs.
There’s also a tendency to try to explain side effects away… especially side effects like a fever and swollen glands, which could be a sign of an infection. You might not think a drug would do that to you.
But according to the reports coming in, those symptoms can start to take hold in as little as two weeks after starting up on the drugs…
And in the case of levetiracetam… they could be completely REVERSED once you stop taking the drug. (Although funny enough, the feds DON’T recommend stopping the drug.)
Now, it’s important for patients to know that those two generic drugs can be offered under a VARIETY of brand names… so it’s best to do a search and see if any anti-seizure meds you’re taking match up with these latest findings.
And this acts as a good reminder to always read the literature that comes when you fill an Rx – because even if you’ve been taking a drug FOR YEARS, it might carry a NEW warning that you’ll need to know about.
If you are taking one of these drugs… and you experience any of the symptoms of DRESS, the FDA recommends you go to the emergency room immediately.
In pursuit of the truth,
Dr. Marc S. Micozzi, M.D., Ph.D.