FDA Panel Decides Acetaminophen Doses Should Be Changed
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On Tuesday, June 30, 2009, thirty-nine government safety experts, who were assembled by the Food and Drug Administration (FDA), recommended ways to reduce deadly overdoses of acetaminophen, which is the leading cause of liver failure in the United States. This liver failure sends about 56,000 people into the emergency room causing about 200 deaths each year. Due to these staggering numbers, the panel called for sweeping safety restrictions on the most widely used painkillers, including decreasing the maximum dose of Extra Strength Tylenol from eight pills of medication to a not yet determined amount and endorsed limiting the maximum single dose from 1,000 mg, or two tablets, to 650 mg; the 1,000 mg dosage should only be available by prescription.
The panel also narrowly voted to eliminate prescription drugs that combine painkilling ingredients with acetaminophen, such as Percocet and Vicodin, citing sixty percent of acetaminophen-related deaths are related to the prescription products. Some panel members, however, disagreed with this decision because so many Americans deal with chronic pain and depend on the medications. If these drugs stay on the market, members of the panel ask that the drugs’ label carry a black box warning, which is the most serious safety label available.
Drug companies avoided the most damaging potential outcome after the panel decided that over-the-counter cold medications, such as Nyquil and Theraflu, which combine other drugs with acetaminophen, could stay on the market. Though these drugs can be dangerous when taken with Tylenol or other drugs containing acetaminophen, the FDA claims they only cause about ten percent of the acetaminophen-related deaths.
Although the FDA is not required to follow the advice of its panels, it usually does. Many doctors believe this is the opportunity to save a lot of people from inadvertent overdoses. For example, college sophomore Madalyn Byrne died after taking eight Tylenol a day for a week due to a toothache. Madalyn’s mother believes that had the bottle said to take four tablets a day instead of eight, her daughter would still be alive.