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Federal authorities are suggesting tougher warning labels for popular over-the-counter painkillers such as Tylenol and aspirin.
The proposed warnings would address the increased risk of gastrointestinal bleeding and liver damage associated with the use of acetaminophen products, as well as nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (found in Motrin and Advil), naproxen (Aleve), and ketoprofen (Oruvail).
Many of these drug makers already have warnings such as these on their drug labels.
The new rule will make the warnings mandatory if it passes. It will also require them to be displayed more prominently, and will require standardized language, said Dr. Charles Ganley, director of the U.S. Food and Drug Administration's Office of Nonprescription Products, Center for Drug Evaluation and Research.
These painkillers contribute to thousands of deaths each year. This is a small percentage of the total number of people taking the drugs, however. Estimates put the number of people taking acetaminophen and NSAIDs at well over 200 million in the United States, Galney said.
“These are rare circumstances but, because the drugs are used by so many people, those rare circumstances start adding up,” he said. “We view this as an important problem that needs to be addressed.”
Concern was also raised over reports of an increased incidence of liver failure connected with acetaminophen use.
The Warnings
Acetaminophen labels will be required to contain the liver warning in bold text further up in the warnings section. The alcohol warning, which was added in the late 90's, is to be included in the new liver warning. The label will also be required to disclose the greater chances of liver damage when the user takes the drug in combination with other drugs. The name “acetaminophen” will be required on the primary display panel, and the type size will have to be bigger.
On NAIDs the label will be required to display the term “nonsteroidal anti-inflammatory drug” prominently on the primary display panel in a large font.
The warnings will also describe the potential for gastrointestinal bleeding in the elderly and people who have had bleeding or ulcers before.
If you or a loved one has been seriously injured or killed by a dangerous or defective drug, please contact us today for a free consultation with a compassionate and effective personal injury attorney.
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