Over the past several days, we’ve highlighted
the deaths and injuries caused by overdosing on acetaminophen, the active
ingredient in Tylenol. We’ve pointed out that the toll does not have
to be so high.
Today, we share some of the more prominent proposals
to reduce the harm from one of America’s most widely used pain relievers.
The ideas come from a variety of sources,
including scientists, the U.S. Food and Drug Administration, regulators in
other countries, industry officials and McNeil Consumer Healthcare, the Johnson
& Johnson unit that makes Tylenol, the best-selling acetaminophen brand.
From 2001 to 2010, more than 1,500 Americans
died from accidentally taking too much acetaminophen, according to data from
the U.S. Centers for Disease Control and Prevention. An additional 1,400 people
intentionally overdosed to commit suicide or died under circumstances in which
their intent was unclear.
1.
Drop the
Daily Total
FDA advisors — prominent doctors, 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 itself adopted the suggestion for its
Extra Strength Tylenol product and now recommends a maximum of 3 grams, or six
pills, per day unless otherwise directed by a doctor. (The company hasn’t
applied this to all its products, nor to Extra Strength Tylenol worldwide.)
WHO
COULD DO THIS? Either the FDA or the
companies that manufacture acetaminophen could change dosing instructions.
2.One
Concentration and Dosing Instructions for Kids’ Products
After confusion between
different concentrations of pediatric acetaminophen led to child deaths, the drug industry in
2011 voluntarily agreed to market only a single concentration in the United
States. For years, most recently in August 2013, the industry has also asked the FDA to allow dosing
instructions on acetaminophen labels for kids under 2 to help prevent the
lethal confusion. FDA advisory panels have told the FDA to do the same thing,
most recently in 2011. So far, the FDA has not required a single concentration,
nor has the agency ruled on whether to require the dosing instructions.
WHO COULD DO THIS? The FDA.
3.Take
Acetaminophen out of Prescription Pain Killers
Vicodin and Percocet are a mixture of powerful pain killing opioids and less
potent acetaminophen. Just why these medications are combined is controversial
– some people argue that adding acetaminophen to an addictive drug only
increases the risk of liver poisoning, with little additional pain-relief benefit.
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 medicines – harder to prescribe and
harder to get. By a small margin, FDA advisors recommended removing
acetaminophen from prescription opioids in 2009. The agency has declined to take
that step, but in 2011 limited the amount of acetaminophen that a single pill
can contain to 325 mg. It also put a so-called black box warning on the label
stating that an overdose can cause death.
WHO COULD
DO THIS? The
FDA and the Drug Enforcement Administration, which plays a large role in
regulating addictive medicines, would have to sign off.
4.Restrict Pill
Quantities
Regulators in the United Kingdom, Germany, Australia
and elsewhere all restrict the purchase of acetaminophen in some way. They
limit how many pills consumers can buy at one time, where they can buy them,
how many pills can be put in one package, or a combination of such measures. A
recent U.K. study found that restricting purchases resulted in a significant
drop in suicides with acetaminophen. In 2009, however, FDA advisors recommended
against such restrictions, and it is unclear whether the agency has the legal
authority to impose them.
WHO COULD DO THIS? Both the FDA and Congress might
need to act.
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. McNeil itself features such instructions on bottles
of Motrin, its brand for the pain reliever ibuprofen. The FDA has not required
it for acetaminophen.
WHO COULD DO THIS? Either the manufacturers or the FDA
could make this change.
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 2014. The agency has not, however, mandated
that over-the-counter medications have the same limit, even though most
acetaminophen is sold over the counter. The result? Without a prescription you
can buy pills that contain double the amount of acetaminophen than those you
could purchase under a doctor’s supervision.
WHO COULD DO THIS? The FDA or the
drug manufacturers.
7.Require Side
Effect Warnings in Advertisements for OTC Drugs
As far back as 1977, a panel of experts warned that the government
needed to crack down on marketing that extolled the benefits of
over-the-counter pain relievers without revealing the risks. By a twist of bureaucratic
history, the Federal Trade Commission regulates advertising for
over-the-counter drugs, not the FDA. That’s why you see those long
announcements after prescription drug ads but not after commercials for, say,
Tylenol or Alleve, another non-prescription pain
killer.
WHO CAN DO THIS? Congress could
pass a law to require ads for over-the-counter drugs to disclose risks, or drug
companies could take this step voluntarily.
8.Acetaminophen
Icon
Acetaminophen is in more than 600 medicines, by the FDA’s count. Regulators and
drug makers worry that consumers can unwittingly overdose by taking two
medicines with acetaminophen – for example, Tylenol and NyQuil. Thirty-five percent of
Americans wrongly think that combination is safe, according to a
nationwide poll commissioned by ProPublica and This American Life and conducted
by Princeton Survey Research Associates International. One proposal aimed at
reducing double-dipping is to create a universal icon to slap on the front of
every product with acetaminophen, a bit like a “caution” sign.
WHO COULD DO
THIS? McNeil, other acetaminophen
makers and the FDA have been considering this idea for more than a decade
without taking action. Last month McNeil announced it would take a step in this
direction: adding a red-letter warning to its bottle caps reading, “Contains
Acetaminophen” and “Always Read the Label.”
9.Grab
Consumers’ Attention by Warning Them an Overdose Can Kill
In almost all overdose cases, patients are at least partly responsible. After
all, they took too much of the drug – and one reason may be that people
often don’t pay much attention to drug labels. But maybe they would if the
label warned, prominently, that an overdose could kill. In fact, Canadian
regulators require over-the-counter acetaminophen to warn about its lethal
potential. And the FDA already
requires prescription medicines that contain acetaminophen to warn that taking
too much can lead to “death.” But it requires no fatality warning on
over-the-counter acetaminophen, even though most of the drug is sold that way.
WHO
COULD DO THIS? The FDA or the manufacturers.
