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Common Pain Relief Drug Linked to Liver Damage

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 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.