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Eric T. Chaffin
Eric T. Chaffin
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Shortage of Tylenol—a Good Thing?

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According to a recent report, stores are short of Tylenol. Go down to your local Walgreen's or Rite Aid and you may have trouble finding it.

The report details the numerous recalls that manufacturer Johnson & Johnson (J&J) has implemented over the last couple of years, due to complaints of a musty, moldy odor in the products, and later reports of contamination from a pesticide and preservative used to treat wooden pallets. Because of these various recalls—26 in all from 2009 to May 2012, affecting Tylenol and other similar J&J products—the shelves are a little light when it comes to Tylenol and Tylenol combination cold and flu solutions.

Patients may be irritated that their favorite brand of pain reliever is suddenly playing hard to get. Personally, I think it's a good thing. I'm hoping that the temporary pause a person may experience upon finding their Tylenol missing will get them thinking about how much they're taking—and whether or not they may be putting their livers at risk.

Expert Panel Recommends Acetaminophen Limitations

About three years ago in 2009, an expert panel convened by the FDA voted to recommend greater regulation of acetaminophen, which is the most commonly used painkiller in America today. Specifically, the panel urged the FDA to switch to prescription status those over-the-counter products containing 1,000 mg of acetaminophen per dose, and to cap the maximum dose available without prescription to 650 mg. Finally, they suggested lowering the recommended daily dose of 4,000 mg (4 g) to no more than 3,250 mg.

The panel based their recommendations on research showing that acetaminophen-related liver failure is affecting hundreds of Americans every year. Five years earlier, a 2004 study published in Hepatology noted that acetaminophen overdose is the leading cause for calls to Poison Control Centers and accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths due to acute liver failure each year. The researchers added that data from the U.S. Acute Liver Failure Study Group registry of more than 700 patients with acute liver failure across the U.S. implicated acetaminophen poisoning in nearly 50% of all acute liver cases in the country.

A later study appearing in the same journal in 2005 noted that the annual percentage of acetaminophen-related acute liver failure increased from 28 percent in 1998 to 51 percent in 2003. Researchers added that "unintentional overdoses"—such as those experienced by people taking Tylenol with another product that also contains acetaminophen—accounted for 48 percent of cases.

"In conclusion," the researchers wrote, "acetaminophen hepatoxicity far exceeds other cases of acute liver failure in the United States."

FDA Takes Baby Steps Toward Stricter Regulation

The FDA has finally made some headway in limiting high doses of acetaminophen. What's discouraging is that as far back as 1977, an agency committee suggested that labels for pain relievers contain a warning that would alert consumers to potential liver damage. The FDA finally announced in January 2011 that it was requiring manufacturers of prescription combination products containing acetaminophen to limit the dose to no more than 325 mg per tablet or capsule. Drug makers will also need to add warnings concerning the risk of liver failure.

These new requirements didn't affect over-the-counter products, however. Apparently the FDA is still considering options for those, since your typical extra strength pill can contain up to 650 mg per dose for extended-release products. J&J has taken some steps of its own, lowering the maximum daily dose on Extra Strength Tylenol to 6 pills per day (3,000 mg) instead of 8 pills (4,000 mg) in the fall of 2011. They planned to revise labels on other acetaminophen products in 2012, and have launched a national initiative designed to educate consumers about the appropriate use of the drug.

Looking back, one wonders why it took so long for J&J to make such changes. Those seriously injured by their drugs are likely to take their grievances to court. Meanwhile, maybe the missing bottle of Tylenol on the shelf will be enough to alert more people to the issue. Likely, though, it will take more individuals coming forward to hold J&J responsible for dropping the ball before we really get the word out to those consumers who are most at risk.