But the company has not embraced a more drastic recommendation by the FDA’s expert panel: eliminating the over-the-counter “extra-strength” formulation altogether, which would mean lowering the acetaminophen dose from 1,000 milligrams to 650 milligrams, or two tablets of 325 milligrams each. The panel said the 1,000 milligram dose should only be available via prescription.
McNeil argues that the lower dose is less effective and could drive people to take anti-inflammatory pain relievers, a different class of drugs that includes aspirin and ibuprofen. Those medicines can cause stomach ulcers and dangerous gastrointestinal bleeding.
FDA spokeswoman Erica Jefferson says the agency is actively working on new rules for both children and adult acetaminophen products. While the agency won’t give a timeframe for completion, the federal government’s website that tracks new regulations lists December as the target date for publishing the proposed rules.
As early as 1977, FDA advisers recommended adding more warnings to the acetaminophen label about liver damage, but the agency didn’t require the language until 2009.
“They are very slow to respond to these things and it’s always a little frustrating,” says Dr. Lewis Nelson of New York University, who chaired the 2009 FDA panel.
ANATOMY OF AN OVERDOSE
Experts first identified acetaminophen overdose as a major public health concern in the 1990s, but it has taken years to form a clearer picture of the problem.
Acetaminophen overdoses occur when the liver is overwhelmed by too much of the drug, producing a toxic byproduct that kills liver cells. Liver failure occurs when most cells are no longer able to function. At that point, a patient then generally has 24 to 48 hours to live without a transplant.
Of the roughly 500 acetaminophen deaths reported annually, about half are accidental, with the rest deemed suicides. About 60 percent of the unintentional overdoses involve prescription opioid-acetaminophen combination drugs such as Percocet and Vicodin, according to a database of liver failure cases run by Dr. Lee at the Southwestern Medical Center in Dallas. Those two products alone were prescribed more than 173 million times last year, according to IMS Health.