Understanding Acetaminophen and How to Make It Safer

Last week we wrote about the commercial and regulatory shortcomings concerning acetaminophen in general and Tylenol in particular. The investigative news outfit ProPublica followed up that comprehensive story with others about how the risks of Tylenol are not well understood by consumers, and how acetaminophen drugs can be made safer.

Approximately 150 people die every year from accidentally taking too much acetaminophen, and thousands more end up in hospitals and emergency rooms for treatment from acetaminophen poisoning. A telephone poll of 1,003 adults by Princeton Survey Research Associates showed that half of the respondents were not aware of safety warnings for acetaminophen, although 8 in 10 said that overdosing on it could have serious side effects.

More than one-third said it was safe to mix Tylenol with another medicine containing acetaminophen, such as NyQuil. That’s disturbing from an accidental overdose point of view-more than 600 different medicines contain acetaminophen.

The take-home message of the survey, said ProPublica, is that there’s a mixed record of success for the warning labels on Tylenol. The results also suggest that the acetaminophen public awareness campaigns sponsored over the last several years by the FDA, the drug industry and McNeil Consumer Healthcare Products, the Johnson & Johnson unit that makes Tylenol, aren’t wholly effective.

Acetaminophen is safe when taken as recommended, but taking higher amounts can result in liver damage and sometimes death.

Since 2009, over-the-counter (OTC) acetaminophen labels have warned that the drug can cause “severe liver damage.” Prescription medications containing acetaminophen must warn that overdosing can lead to “death,” but no such warning is required for OTC acetaminophen. About 6 in 10 acetaminophen meds are sold over the counter.

ProPublica proposes nine ways to reduce the potential harm of acetaminophen.

1. Drop the Daily Total

FDA advisors-physicians, researchers and safety advocates-suggested in 2009 that the agency lower the total maximum daily dose of acetaminophen from its current limit of 4 grams per day, equal to eight extra-strength acetaminophen pills. McNeil adopted the suggestion for its Extra Strength Tylenol product, but hasn’t applied it to all its products, nor to Extra Strength Tylenol worldwide.

2. One Concentration and Dosing Instructions for Kids’ Products

In 2011, after confusing about different concentrations of pediatric acetaminophen led to child deaths (see our blog), the drug industry agreed to market only a single concentration in the U.S. For years, the industry has asked the FDA to allow dosing instructions on acetaminophen labels for kids younger than 2 to help prevent the lethal confusion, and FDA advisory panels have agreed. So far, the agency has not required a single concentration, nor has the agency ruled on whether to require the dosing instructions.

3. Remove Acetaminophen from Prescription Pain Killers
Vicodin and Percocet are a mixture of powerful pain killing opioids and less potent acetaminophen. Some people say that adding acetaminophen to an addictive drug increases the risk of liver poisoning, with little additional pain-relief. But because of a quirk in how opioid drugs are regulated, removing acetaminophen might result in drugs such as Vicodin and Percocet becoming more restricted-harder to prescribe and harder to get. FDA advisors recommended removing acetaminophen from prescription opioids in 2009, but the agency has declined to do so. In 2011 it limited the amount of acetaminophen that a single pill may contain to 325 mg. It also put a so-called “black box” warning on the label stating that an overdose can cause death.

4. Restrict Pill Quantities
Regulators in the United Kingdom, Germany, Australia and elsewhere all restrict the purchase of acetaminophen in some way-how many pills consumers can buy at one time, where they can buy them, how many pills can be put in one package, etc. A recent U.K. study found that restricting purchases resulted in a significant drop in suicides with acetaminophen. But in 2009, FDA advisors recommended against such restrictions, and it’s unclear whether the agency has the legal authority to impose them.

5. Dose Up Slowly
In 2009, McNeil proposed adding language to its Extra Strength Tylenol packages to instruct consumers to take only one pill at a time and increase to two only if they don’t get pain relief-a common medical practice known as taking the lowest effective dose. The FDA has not required such advice for acetaminophen.

6. Limit Pill Strength
The FDA has required that prescription medicines contain no more than 325 mg of acetaminophen per pill to limit the risk of liver damage; drug companies must implement this change by January. But the feds haven’t mandated that OTC medications have the same limit. So you can buy pills that contain double the amount of acetaminophen than those you could purchase under a doctor’s supervision.

7. Require Side Effect Warnings in Advertisements for OTC Drugs
As long ago as 1977, a panel of experts said the government should crack down on marketing that extolled the benefits of OTC pain relievers without disclosing the risks. But the Federal Trade Commission regulates advertising for OTC drugs, not the FDA. That’s why you see those long safety announcements after prescription drug ads but not after commercials for, say, Tylenol or Aleve or other nonprescription pain relievers.

8. Acetaminophen Icon
Because acetaminophen is a component of more than 600 medicines, regulators and drug makers worry that consumers unknowingly can overdose by taking two medicines with acetaminophen, such as Tylenol and NyQuil. One proposal aimed at reducing this “double-dipping” is to create a universal icon for the packaging of every product with acetaminophen, like a “caution” sign.

9. Grab Consumers’ Attention by Warning Them an Overdose Can Kill
In almost all overdose cases, patients are at least partly responsible. One reason might be that people often don’t pay much attention to drug labels. Maybe they would if the label warned, prominently, that an overdose could kill. Canadian regulators require OTC acetaminophen to warn about its lethal potential, and the FDA requires prescription medicines with acetaminophen to warn that taking too much can lead to “death.” But there’s no such requirement for OTC acetaminophen.

For additional information about the proper use of acetaminophen, see the FDA’s Safe Use Initiative.

Tylenol manufacturer McNeil sponsors a Consumer Healthcare website; Get Relief Responsibly, is another resource, as is the Know Your Dose education campaign, a project of the Consumer Healthcare Products Association and the federal government.

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