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Health & Fitness

Let's Talk Tylenol

An article reporting on an FDA panel's recommendation to remove extra-strength Tylenol and it's generic form, acetaminophen, from the market due to liver damage.

In June, a Food and Drug Administration (FDA) panel recommended lowering what has been considered the safe dosage of acetaminophen, the active ingredient in Tylenol. It appears however, that few people have noticed this serious public health recommendation.

The FDA says that for years acetaminophen has been the leading cause of liver failure in the United States. Despite the efforts of educational campaigns that have tried to mitigate the problem, according to the FDA, it's still true. In response to this perceived public health threat, they assembled a group of experts to try to find ways to reduce the number of people sustaining liver damage from acetaminophen. While the FDA isn’t required to take its panel’s recommendations; more often than not it does.

Acetaminophen comes in many forms. It can be found in branded Tylenol products, controlled narcotics such as Percoset, Vicodin and their generics, as well as in Theraflu, Excedrin, NyQuil and other over-the-counter branded and generic medications that are not controlled in any way.

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The FDA panel recommended the removal of Percoset, Vicodin and their generics from the market as well as lowering the maximum dose of over-the-counter products containing acetaminophen. The panel believes that 60% percent of acetaminophen related illnesses and deaths are from their presence in prescription medications — but that leaves 40% of of those injuries coming from non-prescription forms of the drug.

They recommended that the current 1000-milligram dose, which is the equivalent of two extra-strength tablets, be limited to prescription only. Their position is that a 650-milligram dose; which is the same as two regular strength tablets; should be the absolute maximum dose.

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A significant problem is presented when someone has a cold and combines acetaminophen, and a cold medication such as NyQuil, Theraflu, a generic or some other acetaminophen containing product. That easily puts the dose over 650-milligrams and the panel believes it is such a dangerous situation, that some members wanted to remove the cold medications from the market completely. This was not however the recommendation of the majority of the panel. It will be up to the FDA itself, to make the final decision on this and all related matters.

However, things are even more problematic here in Framingham, where at two out of the three stores I checked, all I could buy was the extra-strength version of this medication (I checked the pharmacies twice —each time a week apart). 

When one looks at some of the bulk quantities these medications are available in; it is easy to understand how people could be overdosing. I was making a vitamin and medication run for my mother last week and found that the on Route 9 in Framingham had no regular strength Tylenol or its’ generic, acetaminophen in stock.  There was however an overstocked buffet of items containing the extra-strength version in more forms than I could have imagined existed.  I asked someone from the pharmacy for help and they confirmed there was none of the regular strength type left. 

I then went to on Route 9 and found that they had exactly two bottles in stock.  It’s not just that the product is sold out of the stores — the shelf space dedicated to it is minimum compared to the plethora of other products containing extra strength doses. 

I have subsequently purchased both boxes, one for my mom and the other for myself a week later. Sorry folks, as of Saturday, the cupboard is empty.

The pharmacies aren’t the only one with this issue however. On Thursday, I found the same thing at , except they didn’t even have an open stocking slot for the regular strength version.

For those with moderate pain issues who want to do the responsible and health conscious thing, they can’t seem to do it at the stores I shop in — and given current information, that’s a serious problem.

As a business person, I understand that shelf space is generally dedicated to the products that move — that’s the way stores make money. The faster the product is sold and restocked; the greater the profit. Shelves are usually stocked with the products people buy. However, sales also move product and the only sale bundles were of course on the extra strength version of the products. The fact that the regular strength versions of both the Tylenol brand and the store brand generic were sold out - tells me there is more demand than the stores are meeting. 

The other view to take would be is that with the potential of a ban, stores are dumping their extra strength inventory so they will not have to write off the losses on their house brands later.  I don’t know if that is true; but as a business practice it would be far from unprecedented.

And for the record, acetaminophen isn’t the only over-the-counter medication that can be dangerous. For example, ibuprofen has been linked to sever gastric bleeding, and aspirin can slow blood clotting and many allergy products can cause rapid heart beat or prostate enlargement. Just because a medication is available without a prescription doesn’t mean that it’s harmless. 

There are many people, who can’t take ibuprofen and aspirin-based pain relievers because of gastric, blood or other issues. For many of these people, acetaminophen is their only over the counter option. Certainly, taking one extra strength 500-milligram tablet would be within the recommended dosage limit, but it might not be enough to make a person comfortable. It’s time for us as consumers to ask for the products that are safer for us and not just what the stores choose to put on the shelves.  The theory of supply and demand only works when we make the demands.

It seems that while as a society we were supersizing foods, credit card debt, furniture sizes and houses that many can no longer even pretend they could afford; we were also supersizing medication dosages, and damaging our health in the process.

I think it’s time to get back to right-sizing a lot of things. What do you think? 

Copyright 2011, Cheryl Tully Stoll

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