Are Your Painkillers Actually Killing You?...continued

Abuse Remains Most Dangerous Mistake

Most of those who endanger their health with pain relievers do so by simply taking too much of the drug too quickly.

"We know that people occasionally use the products outside the product label — sometimes on a physician's recommendation, sometimes on their own, and sometimes inadvertently," said Randy Juhl, former chair of the FDA Nonprescription Drug Advisory Committee and vice chancellor for research conduct and compliance at the University of Pittsburgh.

Occasionally, the overdose is intentional.

"I think that most people don't understand just how dangerous these drugs are," Boyer said. "For example, I know of a 'weight loss club' whose members ingested [acetaminophen] because they knew it would make them vomit. The girls in the club kept winding up in hospitals. … And nobody could figure it out until one died."

Acetaminophen is also a common drug for those who attempt suicide by overdose.

In most cases, however, the overdoses are unintentional, and the mistake is often an easy one to make.

"Consumers are generally not aware of the four-gram maximum daily dose of acetaminophen," said Edward Krenzelok, director of the Pittsburgh Poison Center and professor of pharmacy and pediatrics at the University of Pittsburgh Medical Center.

Worse, for children the maximum dose is significantly smaller, at 2.6 grams per day.

Yet many adults and children may be in danger of overdosing because they don't perceive the drug as potentially harmful.

"Most people underestimate the potency of medications, and may act on the principle that 'if one is good, two is better,'" said Dr. Vivian Tellis, chief of the division of transplant surgery at Montefiore Medical Center in New York City.

In addition, because numerous "combination" medications contain significant amounts of pain relievers mixed in with other active ingredients, consumers may end up taking many different brands at once.

"Often people take over-the-counter compounds for cold, cough, sinus problems, allergies, arthritis or other common conditions," said Dr. Doris Cope, professor and vice chair for pain medicine at the University of Pittsburgh School of Medicine's Department of Anesthesiology. "These proprietary medications, more often than not, already contain the maximum daily doses of acetaminophen, aspirin or ibuprofen."

"When a patient then adds acetaminophen, aspirin or ibuprofen they will reach toxic doses without even realizing how much they have taken," Cope said.

Alcohol is another factor that makes certain OTC drugs even more damaging to the liver. Though the danger of mixing alcohol with acetaminophen has been publicized in the past, many remain unaware of the danger.

"The risk of liver damage with Tylenol is significant, when taken in high doses and when mixed with alcohol," Rajapaksa said. "Even in only slightly higher doses, Tylenol can cause liver damage in susceptible people. And Tylenol is the No. 1 cause of acute liver failure in the U.S."

Effect of FDA Regulations May Be Negligible

Even though the labeling guidelines proposed by the FDA will likely be applied to boxes and bottles, the impact of the warnings may not be enough to protect many consumers.

"It probably will have little impact on the patient since many do not read the label anyway," Krenzelok said.

As for physician reaction to the labeling changes, Krenzelok said, "I do not think that it will change the prescribing habits of many physicians. Most probably have a degree of comfort with these meds."

Some in the medical community, however, remain optimistic that the stronger labeling will have a positive effect.

"Physicians will continue to recommend these medications, but both the patient and the physician will become more aware of side effects," Weinstock said. "They will stop these medications more readily if early signs of side effects develop."

"Perhaps the most helpful aspect of the labeling change is the provision for all products containing these drugs to prominently display that characteristic on the label," Juhl said.

"This should reduce the inadvertent overdosing that may occur when consumers take — or give to their kids — two or three products all of which contain acetaminophen or another NSAID."

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