What’s the world coming to?

Has there been a shift in the world’s axis? Have pigs started to fly? Has the FDA done something right ?

Well, I don’t know about the first two. But as unbelievable as it sounds…the FDA has finally gotten something right. In fact, it’s gotten three things right. And three recent things at that.

So let’s give credit where credit is due.

Last month, the FDA took the first steps to ban trans fats in prepackaged foods. Next, it decided to reign in the sales of dangerous and ineffective “anti-bacterial” agents. And now, it’s going after acetaminophen (Tylenol). In fact, in January, the FDA recommended that healthcare professionals stop prescribing combination prescription pain relievers that contain more than 325 mg of acetaminophen.

And get this…

On the FDA’s website is this statement: “Limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.”

The FDA also admits cases of severe liver injury with acetaminophen often occur in patients who:

-took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;

-took more than one acetaminophen-containing product at the same time; or

-drank alcohol while taking acetaminophen products.

Without a doubt, Tylenol is one of the most dangerous drugs on the market. And it’s far too easy to overdose on it. That’s why up to 80,000 men and women land in the emergency room each year with liver damage. Plus, it kills 500 people outright each year because of liver failure. And we’ve known about this product’s safety issues, and its ability to kill victims outright, for at least 30 to 40 years.

In fact, in the 1970s, I worked at McDonnell-Douglas Corp. (now Boeing) to adapt “space age” technology from Sky Lab to screening drugs for the clinical lab. Acetaminophen was one of the first drugs we studied–since it was already widely recognized to have serious toxicities.

Yet, up until recently, the government seemed to ignore the data. And it allowed this truly toxic synthetic chemical almost complete freedom in the marketplace.

So, last month’s announcement came as quite a pleasant surprise to me.

Apparently, more than half of manufacturers have complied with this FDA request. But some combo-drug products that contain more than 325 mg acetaminophen still remain on the market. So, the FDA intends to initiate proceedings to withdraw their approval.

Of course, the FDA’s latest move only applies to prescription drug combinations that include Tylenol. Such as Percocet and Vicodin. But hundreds of OTC medicines include Tylenol. Common products such as pain relievers, fever reducers, and sleep aids contain Tylenol. So do many cough, cold, and allergy medicines.

The FDA says it will address these OTC products in a separate regulatory action. In the meantime, the agency warns you to be aware of products (both prescription and OTC) that contain acetaminophen. It’s far too easy to take too much. (Hopefully, you never take it at all!)

The FDA created a new website called www.knowyourdose.org that lists all the products on the market that contain acetaminophen. It’s a pretty good website, actually, for the government. And user-friendly too. (Maybe the White House should have checked with these guys first about their shameful disaster of an Obamacare website.)

I have definitely turned my head more than once so far this year and thought, what’s gotten into the FDA lately? They’re actually getting a few things right. And that’s some very good news for the new year.

It’s nice to have some good news from a government agency for a change. It makes me think that once in a while the citizens actually get a little something back for all their hard-earned dollars confiscated by the government. At least these recent moves finally begin to match the political rhetoric about looking out for the middle class consumer.

What’s next for the FDA?

Objectivity in reviewing new drug applications or dietary supplements?

Now, I’ve gone too far.


“FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers,” Federal Drug Administration (www.fda.org) 1/14/2014