FDA Considering Acetaminophen Ban in Cough, Cold Meds

Liver damage is possible

When people have a bad cold or cough, many resort to over-the-counter medications in order to feel normal again. I’ve done it before. I use cough syrup, Vicks, Sudafed, Advil and even whole room evaporators to stem the tide of  snot. Yes, it’s disgusting, and no, I don’t use all of those at once. And now, I’ll think twice about using products with acetaminophen (Tylenol, cold and cough syrups, et al). If I need to spend more on something else, I will. I’ll even take out unsecured loans for quick cash if I have to do so.

Considering that too much  acetaminophen can cause liver damage, I’ll take the safe route. Now that the FDA is considering banning it in cold and cough medications – for fear that people were ingesting too much – perhaps people will start to believe the warnings about acetaminophen. They’ve been around for years.

“A clear public health benefit”

Susan Heavey reports for Reuters that Johnson & Johnson, Procter & Gamble and other manufacturers are all begging at the FDA’s doorstep. Their plea is to keep cough and cold drugs with the pain reliever acetaminophen on the market, despite the risk of overconsumption they pose. Too many people chug cold and cough syrup when they’re sick, which could be killing them. An Obama-empowered FDA may take the matter into their own hands.

The medical companies are of course in favor of a more obvious warning on their packaging. If they could get away with it, they’d also be in favor of passing off carbolic acid as a tangy fruit drink/colonic. All in the name of profits!

“We believe there is a clear public health benefit with OTC (over-the-counter) products containing acetaminophen,” said Consumer Healthcare Products Association (CHPA) President Linda Suydam to an FDA advisory panel.

What a watchdog!

The FDA has known about the potential acetaminophen has to cause liver damaged for decades. Now they’re worried that the trend of including it in cold and cough medicines can lead consumers into taking too much of the substance without realizing it. Stronger warning on packages has been considered in the past, but now the FDA is exploring whether it isn’t wiser to remove such combination drugs from the U.S. market.

Drug companies would be hit hard in the wallet by a total ban of acetaminophen-containing products. Total profits from such drugs in the U.S. in 2008 was $2.6 billion, according to IMS Health. About 80 percent of that total comes from combination drugs sold over-the-counter and direct to consumers. Thus, Nearly 80 percent of that stems from combination products sold directly to consumers, it said. That would be nearly $2.1 billion in lost profits, a massive cut.

In hot pink neon

The drug companies hope that the FDA will consider a compromise action. For instance, the amount of acetaminophen in over-the-counter medications could be reduced, which would both lower the strength of the pain relief and reduce the liver damage risk. For prescription medication, one proposal requires that an obvious warning be placed on the box.

Ever out to cover their collective assets, the manufacturers are attempting to deflect the FDA’s gaze from their cash cow. They claim that most overdoses come when people are attempting to commit suicide, and that prescription meds lead to more deaths than those distributed over-the-counter. And that makes the risk OK. Just keep saying that.

A bolder warning system did go in place in April, but the new warnings being considered would be huge, bold and black.

Here are some studies, people

Paul Desjardins, Vice President of Wyeth Consumer Healthcare, thinks a ban would be “overly drastic.” He believes the FDA should “require approval of nonprescription acetaminophen products before they could be sold.” Wyeth sells Robitussin Cough Cold & Flu and Dristan Cold products. These contain acetaminophen.

The FDA considers acetaminophen safe if it is used as directed, but they are concerned that the increased instances of liver failure since the 1990s show that “overdose remains a serious public health problem.” While estimates vary, a 2007 Centers for Disease Control and Prevention report found that “acetaminophen was the most common cause of the estimated 1,600 cases of acute liver failure that year,” according to the FDA. Combine that with alcohol consumption and the risk increases almost exponentially.

But if people can’t understand the warnings?

Here’s where legislating based upon the lowest common denominator – the illiterate, those of lesser education or those who are simply careless – comes into play. One of the FDA panelists, researcher Ruth Day of Duke University, is concerned that if consumers cannot find or understand package warnings, “What’s the point?” If that’s the case, it’s likely that no packaging design change can save such people.

I say that cold and cough medications don’t need to have a pain reliever thrown in just to prevent people from having to “juggle medications” (the drug companies use this term). I think that Americans’ tolerance for discomfort has become so low in this “me first” world that any little thing is considered “pain.” This is not to discount those who are truly suffering, but to weed out those who could use some toughening up. Take out the acetaminophen and make cowboys and cowgirls out of ‘em! The big manufacturers may need quick cash, but at least the poor people won’t need unsecured loans for extra hospital visits.

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