Over-The-Counter Pills Left Out of
New FDA Acetaminophen Limits
Consumers will still be able to buy pills with up to twice that dose
over the counter at gas stations and grocery stores - information for
seniors below article
Jeff Gerth and
T. Christian Miller, ProPublica
While federal drug regulators move to enforce a ban on prescription
drugs with more than 325 milligrams of acetaminophen, consumers will
still be able to buy pills with up to twice that dose over the counter
at gas stations and grocery stores. (Lars Klove for ProPublica)
Jan. 16, 2014 - Earlier this week,
the U.S. Food and Drug Administration urged health care providers to
stop writing prescriptions for pain relievers containing more than 325
milligrams of acetaminophen, the active ingredient in Tylenol.
announcement was aimed primarily at popular prescription medicines
that combine acetaminophen with a more powerful opioid such as
hydrocodone. Agency officials said they had determined that “there are
no available data” to show that the benefits of having more than 325
milligrams of acetaminophen in a single pill outweighed the risks from
taking too much of the drug.
The announcement followed up on a
similar 2011 FDA admonition to drug makers and was the latest turn in a
long-running deliberation over the regulation of acetaminophen.
As documented in a
ProPublica series last year, the FDA has delayed for decades
enacting tougher rules on acetaminophen. While generally considered safe
when taken as recommended, relatively small overdoses have been shown to
cause liver damage and even death. Each year, the drug accounts for
about 150 accidental deaths, half of all cases of acute liver failure
cases and tens of thousands of emergency room and hospital visits,
according to federal data and scientific studies.
As far back as 1977, a panel of
outside experts convened by the FDA recommended the agency set the
standard dose of over-the-counter acetaminophen at 325 milligrams per
pill, citing the possibility of liver damage. But the agency allowed 500
milligrams and even 650 milligrams single doses of the drug for sale.
Today, the most commonly sold form of over-the-counter acetaminophen
contains 500 milligrams in a single pill.
2008 FDA review found that the agency’s approval for such a dose was
based on “few and limited” studies submitted in the 1970s by McNeil
Consumer Healthcare, the Johnson and Johnson unit that makes Tylenol.
Two studies showed that two 500-milligram pills were “marginally” more
effective than two 325-milligram pills, while two other studies showed
FDA Recommendation on Acetaminophen
2014 - FDA is recommending health care professionals discontinue
prescribing and dispensing prescription combination drug
products that contain more than 325 milligrams (mg) of
acetaminophen per tablet, capsule or other dosage unit. There
are no available data to show that taking more than 325 mg of
acetaminophen per dosage unit provides additional benefit that
outweighs the added risks for liver injury. Further, limiting
the amount of acetaminophen per dosage unit will reduce the risk
of severe liver injury from inadvertent acetaminophen overdose,
which can lead to liver failure, liver transplant, and death.
recommends that when a pharmacist receives a prescription for a
combination product with more than 325 mg of acetaminophen per
dosage unit that they contact the prescriber to discuss a
product with a lower dose of acetaminophen. A two tablet or two
capsule dose may still be prescribed, if appropriate. In that
case, the total dose of acetaminophen would be 650 mg (the
amount in two 325 mg dosage units). When making individual
dosing determinations, health care providers should always
consider the amounts of both the acetaminophen and the opioid
components in the prescription combination drug product.
severe liver injury with acetaminophen have occurred in patients
• took more than the prescribed dose of an
acetaminophen-containing product in a 24-hour period;
• took more than one acetaminophen-containing product at the
same time; or
• drank alcohol while taking acetaminophen products.
Ninfa Redmond, a toxicologist who
helped carry out the 1977 panel’s exhaustive, three-year study, said she
was surprised that such big doses continued to be sold 40 years later.
“It never occurred to any of us
that you make a product with that high a dose,” Redmond said. “I use the
drug when I travel, but I use 325 milligrams,” she added.
Tuesday’s recommendation only
applies to prescription drugs, not the over-the-counter products that
make up about 80 percent of the market, according to the FDA. That means
that you will still be able to walk into a gas station or grocery store
and buy pills with up to 650 milligrams of acetaminophen, while your
pharmacist is now discouraged from dispensing any product with more than
half that amount.
One reason for this is that the FDA
has more power to regulate prescription drugs than over-the-counter
In June 2009, an FDA advisory panel
urged various limits on both over-the-counter and prescription drugs.
But over-the-counter drug makers, led by McNeil, resisted efforts to
reduce pill strength. In a 2009 letter to the FDA, McNeil noted that
500-milligram pills accounted for 92 percent of U.S. acetaminophen
sales. McNeil suggested that removing the pills from the market would
“burden” consumers by blocking access to pain relief.
The company also noted that
reducing pill strength would require a “significant amount of time” in
the over-the-counter regulatory system. If the agency decided not to
pursue such a reduction, McNeil pledged it would add language to their
drug labels recommending a lower total daily limit of 3,000 milligrams –
or six extra strength pills.
“Other proposals could take
significantly longer to implement,”
wrote Lynn Pawelski, the company’s vice president for regulatory
In 2011 the company changed its
label on Extra Strength Tylenol to reflect the lower recommended maximum
McNeil, in an emailed statement,
said the company still opposes any reduction in pill size for Extra
Strength Tylenol and is committed to the health and safety of its
“As the makers of Tylenol ... the
health and safety of consumers is our number one priority,” the
statement said. “Our position was on OTC medicines and that position has
Even with prescription drugs
containing acetaminophen, the FDA has moved slowly. In 2011, the agency
warned manufacturers to stop making prescription pills with more
than 325 milligrams by January 2014. In this week’s announcement, the
agency said more than half of all drug makers had complied with the
three-year deadline, but acknowledged that some continued to sell
prescription combinations with more than 325 milligrams of
ProPublica found that many of the
largest pharmaceutical companies had dropped the amount of acetaminophen
in their combination products to meet the FDA target, including the
popular pain killer Vicodin, by AbbVie Inc.; Percocet, by Endo
Pharmaceuticals; and Tylenol with Codeine, by the prescription drug unit
of Johnson and Johnson.
In response to questions, the FDA
was unable to say how many companies had failed to comply, or what
percentage of the market they represented. The agency said it would now
start to crack down on the remaining combination pills. “If
manufacturers have not voluntarily withdrawn these products from the
market, the FDA will take the necessary steps to withdraw them,” Morgan
Liscinsky, an FDA spokesman, wrote in an e-mail.
When? “In the near future,” the
agency announcement said.
>> This article is part of an ongoing
Overdose. About 150 Americans a year die by
accidentally taking too much acetaminophen, the active ingredient in
Tylenol. The toll does not have to be so high.
ProPublica is an independent, non-profit newsroom that produces
investigative journalism in the public interest. The work focuses
exclusively on truly important stories, stories with “moral force.” It
reports to do this by producing journalism that shines a light on
exploitation of the weak by the strong and on the failures of those with
power to vindicate the trust placed in them.
Acetaminophen Safe Use for Seniors
Acetaminophen Safe Use for Seniors
program is an online educational module on safe use of
acetaminophen products targeting older adults and caregivers
by National Council on Patient Information and Education
This program was developed with input from a project
advisory team with expertise in advocacy, outreach, health
communications and safe use of medicines for/to older
program is integrated into NCPIE's
Medication Use Safety Training for Seniors™
program site, located at
and can be used by as a stand-alone or in conjunction with
the MUST for
Acetaminophen Safe Use for Seniors
program can be used by older adults, caregivers and
healthcare professionals for self-education and to present
this information in their communities (for example, at a
senior center, place of worship, library, pharmacy or
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