WASHINGTON, Sept. 18 (UPI) -- The Food and Drug Administration plans to take a closer look at the toxicity of common painkillers such as aspirin and acetaminophen because the agency continues to receive reports of organ failure and other adverse effects associated with these over-the-counter drugs.
Between 1998 and mid-2001, the FDA received more than 300 reports of liver damage, including 134 deaths, associated with acetaminophen, which is sold under various trade names including Tylenol. The agency also received 121 reports of kidney failure, including eight deaths, associated with the use of non-steroidal anti-inflammatory drugs -- a class that includes ibuprofen, naproxen (Alleve) and ketoprofen.
The FDA's non-prescription drugs advisory committee -- a panel of independent experts -- is slated to examine these issues at a two-day meeting beginning Thursday.
"There are risk issues related to each of the products," a source at the FDA who requested anonymity told United Press International. "They're safe products. We're not going to take them off the market," the source said, adding, "There's been some indication that there's a problem and we want the committee to explore whether they think it's significant enough that we do something about it."
The agency is considering whether to add stronger warnings to product labeling or do more to educate consumers and physicians about the risks, the source said.
Tens of millions of Americans use acetaminophen-containing products, and the risk of liver toxicity has been known since 1977. A recent study found that acetaminophen was the biggest cause of liver failure in the United States, Australia and Europe.
Acetaminophen-containing products currently carry a warning that the drug can cause liver damage and that patients should ask their physician about using the drug if they consume three or more alcoholic beverages per day, as this seems to increase the chance of liver damage.
In many of the cases of liver failure associated with acetaminophen, patients unknowingly used two or more products containing the drug, thereby increasing their intake without realizing it, according to FDA documents. In other cases, people were heavy alcohol drinkers or alcoholics.
More cases of liver damage due to acetaminophen are being detected but this is largely because physicians now are more aware of it, not because more cases are actually occurring, Caroline Riely, who will be testifying at the meeting and serves as associate medical director of the American Liver Foundation, told UPI.
Riely, also a professor of medicine and pediatrics at the University of Tennessee, agreed with the FDA that many of the acetaminophen cases are inadvertent.
"People just happen to take too much because they don't realize they are taking two products that contain acetaminophen," she said. "Part of the problem is with labeling."
The information on the product packaging does not make it clear that people should avoid other medications that contain acetaminophen or that the drug can be toxic at a relatively low dose. "It may be that the safe dose needs to be lower," she said.
"The idea that people are taking multiple products containing acetaminophen without knowing it is worrisome," said Peter Lurie, deputy director of Public Citizen's Health Research group, a consumer advocacy organization in Washington. Lurie said the maximum dose should be reduced and noted in "a large fraction of the liver toxicity cases people were within the supposedly safe range" and had not overdosed.
The FDA committee will also be focusing on aspirin, ibuprofen, ketoprofen and naproxen. Although these products are only rarely associated with liver damage, there is a concern about gastrointestinal bleeding and kidney damage, the agency's Susan Cruzan told UPI.
Cruzan noted the situation appears to be the same as with acetaminophen and people are unintentionally overdosing by unwittingly taking two or more products that contain the drug. Another problem may be that people do not understand they should not exceed the maximum dosage stated on labeling because some people routinely exceed this.
Aspirin was associated with nearly 190 reports of gastrointestinal bleeding last year. Between 1998 and July 2001, the FDA received more than 100 reports of gastrointestinal bleeding associated with ibuprofen; 89 for naproxen; and three for ketoprofen.
These products currently carry a warning they can cause stomach bleeding and advises consumers to consult with their doctors if they drink three or more alcoholic beverages per day.
