An expert panel convened by the U.S. Food and Drug Administration voted today to recommend greater regulation of acetaminophen -- the most commonly used painkiller in the country.
Specifically, the panel at the Center for Drug Evaluation and Research Joint Meeting of the Drug Safety and Risk Management Advisory Committee, the FDA's Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee has already voted to urge the FDA to switch to prescription status the strongest of the over-the-counter acetaminophen products, which contain a 1,000 mg dose.
The decision affects a variety of popular over the counter products, including the recommended dosage of Extra Strength Tylenol and other Tylenol products. The dosing instructions for Extra Strength Tylenol indicate that adults should take two 500-mg tablets every 4 to 6 hours.
The panel will also recommend that the FDA cap the maximum dose available without prescription at 650 mg and lower the maximum recommended daily adult dose from its current level of 4,000 mg. The panel, by a narrow 17-to-20 margin, voted not to recommend pack size limits for nonprescription versions of the drug.
The decisions come in the wake of research revealing that hundreds of Americans each year experience acute liver failure as a result of taking acetaminophen and about 100 people die annually from overdosing on the painkiller, either intentionally or unintentionally.
Although researchers have found that the drug, the key ingredient in Tylenol products, is safe if taken at recommended levels, its prevalence as a somewhat hidden ingredient in a variety of pain relievers, fever reducers and cough medicines means patients don't realize they are taking several drugs that all contain acetaminophen.
Moreover, combining the medication with alcoholic beverages increases the risk of liver damage.
The votes are non-binding, but the FDA usually follows the panel's advice. A final decision by FDA is likely months away.
Several hepatic experts said that the additional curbs that the FDA panel has recommended for the drug are sorely needed.
"I have cared for several patients with acute liver failure caused by the unintentional use of multiple acetaminophen-containing medications who died because they developed absolute contraindications for liver transplantation," said Dr. John Vierling, director of Baylor Liver Health and chief of hepatology at the Baylor College of Medicine in Houston. "Approximately 30 percent of patients with acute liver failure in need of a liver transplant die on the waiting list or are removed from the waiting list when an absolute contraindication develops."
Dr. Robert Squires, clinical director of the Division of Pediatric Gastroenterology at the University of Pittsburgh School of Medicine, agreed that the suggestion to limit the daily dose of the drug is wise. "While four grams per day for a day is safe, there may be circumstances that would make this dose problematic," he said. These circumstances, he said, could include cases in which acetaminophen pills are taken with other acetaminophen medication, taken with alcohol, or taken in association with the prolonged fasting one might experience when they are sick.
Squires added that he also supported the notion that the sales of such drugs to consumers should be limited to "unit of use" packages.