FDA Group Issues Cautions on Acetaminophen Overdose

Commonly Used Pain Drug Poses Serious Danger in Certain Cases, FDA Says in Cutting Dosage

When Antonio Benedi of Springfield, Va., felt a case of the flu coming on one weekend in February 1993, he did what millions of others do -- he reached for a common over-the-counter pain medication.

"I was taking Tylenol like I was supposed to, by the label," he said.

A few days later the then 37-year-old Benedi was in a coma and in desperate need of a liver transplant.

Benedi, like hundreds of Americans each year, experienced acute liver failure as a result of taking acetaminophen, the most commonly used painkiller in the country today. Many of these cases are due to either intentional or unintentional overdose. Past research also suggests that combining the medication with alcoholic beverages increases the risk of liver damage.

But Benedi, who was formerly a special assistant to President George H.W. Bush, said that while he did take the medicine on a mostly empty stomach, he neither overdosed on acetaminophen, nor had an alcoholic beverage while he was taking the drug. He said he did occasionally enjoy a glass of wine, but never while taking acetaminophen.

"It's not the mixing of the two; I never misused anything," he said. "I took Tylenol as recommended for three days. By Monday night, my liver was failing. By the time I reached the hospital I was near death."

Today, Benedi, now 53, is still living with the transplanted liver he received 16 years ago. Three years ago he required a kidney transplant as well -- a result of the damage that his organs sustained from the anti-rejection drugs he had to take after his liver transplant. And now this transplanted kidney may be failing as well.

On Wednesday, a U.S. Food and Drug Administration working group released a report urging stronger warnings and stricter dose limits for drugs that, like Tylenol, contain acetaminophen -- and hence may pose an increased risk of liver injury to those who use them improperly.

Among other things, the recommendations call for moving the maximum adult daily dose for acetaminophen to no more than 3,250 milligrams from the current max of 4,000 milligrams per day. The recommendations would also limit the strength of immediate release versions of the drug and place greater controls on the use of acetaminophen in liquid formulations for children.

Limit Doses of Tylenol or Acetaminophen

McNeil Consumer Healthcare, a Johnson & Johnson subsidiary and the manufacturer of Tylenol, said in a statement Thursday that they fear the recommendations could have the effect of steering consumers away from an appropriate and safe drug.

"While we share the FDA's mutual goal of preventing and decreasing the misuse and overdose of acetaminophen, we have concerns that some of the FDA recommendations could discourage appropriate use and are not necessary to addressing the root causes of acetaminophen overdose," the statement reads.

Still, emergency room doctors are no strangers to acetaminophen overdoses. Dr. Richard O'Brien, a spokesman for the Dallas-headquartered American College of Emergency Physicians, said that such cases are very common is his emergency department -- and not all are intentional overdoses in which patients have tried to commit suicide.

"I do see an occasional overdose where people don't read the label of multiple products," he said. "The combination products where they're taking the equivalent of three times the dose, multiple times a day... acetaminophen is a liver toxin, and I have seen people die of liver failure from it."

Liver transplant specialists agreed. "People are frequently pushing the toxic dose limits by taking too much directly and by unknowingly consuming in other products in parallel," noted Dr. Dan Salomon, transplant biologist at the Scripps Research Institute in La Jolla, Calif.

Dr. Jeffrey Punch, chief of the Division of Transplantation at the University of Michigan Transplant Center in Ann Arbor, Mich., said he has seen patients in need of a liver after problems linked to acetaminophen, "especially patients that take over-the-counter acetaminophen as well as a narcotic drug like Vicodin that also includes large amounts of acetaminophen.

"It is made worse if they take too much acetaminophen along with alcohol and/or while fasting," he added.

Lingering Concerns Over Acetaminophen Overdose

The report is not the first time that concerns over the potential for acetaminophen overdose have surfaced. In 2002, Dr. Peter Lurie of the consumer advocacy group Public Citizen appeared before the FDA's Nonprescription Drugs Advisory Committee to relay concerns about unintentional overdoses associated with acetaminophen. In November 2005, a study in the journal Hepatology found that the majority of acute liver failure cases in the U.S. were due to acetaminophen poisoning. And more recent research has suggested that these cases may be on the rise.

Worse, O'Brien said, is that because many who take the medicine are already sick, they could be experiencing the side effects of acetaminophen poisoning without knowing it.

"That's the problem because some of the symptoms are like the flu: nausea, vomiting, and abdominal pain," he said. "It's usually fatal over a day or two."

But Punch said that even the new recommendations may not have a great impact on public health.

"I support the measures, but I don't think the change in maximum dosage will have much effect," he said.

Protecting Yourself From Acetaminophen Overdose

Punch said that if there is a take-home message for consumers, it would be the importance of paying attention to dosage recommendations for acetaminophen.

"It is found in cold medicines, in prescription pain relievers, and in [over-the-counter] pain relievers," he said. "People think that OTC drugs are benign, but they can be just as dangerous as prescription drugs if not taken correctly."

As for Benedi, a jury later found in his favor in an $8 million decision against Johnson & Johnson.

"I went through hell, and so did my family, watching me almost die," he said. "People should really be aware of the dangers of taking Tylenol when not eating properly and if they are used to having a beer or two over the weekends."

The Associated Press contributed to this report.

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