Health Discoveries in General Health News
Prescribed acetaminophen dosage reduced by FDA
January 14, 2011
The amount of acetaminophen in prescription combination products, linked to the potential risk of liver toxicity, has been limited to 325 milligrams in each tablet or capsule, according to new requirements of the U.S. Food and Drug Administration.
The FDA also announced it is now requiring manufacturers of these products to add a warning on their labels that acetaminophen carries a potential risk of "severe liver injury."
Over-the-counter drugs products that contain acetaminophen aren't affected by the FDA decision. The elimination of the higher-dose acetaminophen products will take place over three years.
Dr. Sandra Kweder, a deputy director in the FDA's Center for Drug Evaluation and Research, said there is no immediate danger to patients who take them and that liver damage usually occurs when patients take more than one product containing the drug and go over the maximum dosage of 4,000 milligrams in a 24-hour period.
Within the North Shore-LIJ Health System, a clinical trial is targeting HCC tumors with a combination of radio frequency thermal ablation (RFA), the standard therapy for inoperable patients with liver cancer, and an experimental drug, ThermoDox.
The FDA also announced it is now requiring manufacturers of these products to add a warning on their labels that acetaminophen carries a potential risk of "severe liver injury."
Over-the-counter drugs products that contain acetaminophen aren't affected by the FDA decision. The elimination of the higher-dose acetaminophen products will take place over three years.
Dr. Sandra Kweder, a deputy director in the FDA's Center for Drug Evaluation and Research, said there is no immediate danger to patients who take them and that liver damage usually occurs when patients take more than one product containing the drug and go over the maximum dosage of 4,000 milligrams in a 24-hour period.
Within the North Shore-LIJ Health System, a clinical trial is targeting HCC tumors with a combination of radio frequency thermal ablation (RFA), the standard therapy for inoperable patients with liver cancer, and an experimental drug, ThermoDox.