An over-the-counter painkiller widely used around the globe is not as
safe as many people think. An expert panel told the U.S. Food and Drug
Administration that acetaminophen is responsible for acute liver damage
if taken in too high a dose.
Margalit
Ratner took Tylenol, a brand name for acetaminophen, to relieve
migraine headaches. She says she never took more than the recommended
dose. She ultimately needed a liver transplant.
"The
medication which made me feel better and take away my headaches or any
other pains...could make me so sick...it just didn't make sense to me,"
Ratner said.
Acetaminophen is also known as paracetamol. Dr.
Robert Brown explains why people like it.
"It's so popular because it's
effective and, compared with other pain relievers, it's easier on the
stomach and has virtually no side effects when used at the right dose,"
he said.
But what is the right dose? Research shows that taking
too much can result in acute liver damage and even death. Current
instructions on the package recommend that adults take up to two 500
milligram tablets every four to six hours.
A panel of experts
says that is too high, and recommends that the Food and Drug
Administration limit acetaminophen products containing 1,000 milligrams
to prescription only. It also recommends lowering the non-prescription
dose to 650 milligrams and reducing the maximum daily dose to less than
4,000 milligrams.
Dr. Neil Farber was on the panel. "If we're
trying to save lives of the people who have unintentional overdoses,
this is the best way to do it," he said.
But there is a
problem. Acetaminophen is in more than 200 over-the-counter medicines,
including sleep aids and cold and flu medications. It is easy to see
how a patient can take too much.
"Families need to read the labels and make sure they
know whether it is a prescription product or an over-the-counter
product and what's in it and how much," Dr. Sandra Kweder with the
drug agency warns.
The panel also recommended taking Percocet and Vicodin off the market.
Those are prescription-only painkillers that combine acetaminophen with an opiate.
At
the Lombardi Cancer Center at Georgetown Hospital Dr. Andrew Putnam
says he is concerned about doctors' ability to manage patients pain if
these two drugs are not available.
"I think a lot of physicians
are comfortable writing for Percocet, but not comfortable writing for
oxycodone which is the drug that's in Percocet. While I'm not in favor of taking these drugs completely off the market, I think we need more education," Dr. Putnam said.
More education for patients and more education for doctors.
"Many
times I think regular oxycodone, which doesn't have the acetaminophen
in it, and therefore is less risky in that way, would do the same job
in taking care of pain," Dr. Putnam said. "But people continue to write
for the Percocet."
It will likely be months before the drug
agency makes a final decision on acetaminophen. One panel member said
Americans take so much of it that he is surprised they do not have more
liver damage.
