Causing quite a stir in the world of medicine, the FDA has made a decision to cut back on the maximum dosage of Tylenol. More specifically, they’re going to lower doses of acetaminophen to 2600 milligrams from 4000 milligrams. The reason is because it can cause liver damage. For the sake of comparison, single pill of Extra Strength Tylenol contains 500 milligrams.
The decision came in part from research showing that acetaminophen overdoses have lead to 56,000 emergency-room visits, 26,000 hospitalizations, and 458 deaths from 1990 through 1998. While some of the overdoses were suicide attempts, many were accidental. They happened because patients took more than one product with acetaminophen contents.
Because of this, the FDA panel has recommended banning the prescription painkillers Percocet and Vicodin, both of which contain acetaminophen.
Endo Pharmaceuticals Holdings, the makers of Percocet, have plans in store to work with the FDA to find a way to keep the drug on the market. It brought in $129 million in sales last year, and would be a huge loss for the company.
Abbott Laboratories of Illinois, the makers of Vicodin, did not comment on their plans at the time of this writing.
While the FDA is not required to follow the advice of the advisory panel, it usually does. It is not clear, however, when the agency will make its’ final decision. The panel also took a vote on the 1,000-milligram dose of acetaminophen, voting to make it available only by prescription.
U.S. consumers spend $2.6 billion yearly on 28 billion doses of products containing acetaminophen, the FDA said, citing data from IMS Health.
McNeil Consumer Healthcare, the Fort Washington unit of Johnson & Johnson that makes Tylenol, said in a statement that it disagreed with the panel’s decision. In its statement, McNeil said it worried the vote would lead consumers to use other pain relievers, which have their own risks. Alternatives such as aspirin can cause gastrointestinal bleeding, for example. “The safety and efficacy of acetaminophen has been established in over 150 clinical studies and is supported by over 50 years of clinical use,” McNeil said.
Cesar Alaniz, a clinical pharmacist and associate professor at the University of Michigan, said that the drug was safe at recommended doses, but that his research showed that consumers were ignorant about how to use it safely. “The problem is that not enough of the public knows what a potential toxic dose is,” he said. He was coauthor of a study that looked at 128 adult patients who overdosed on acetaminophen. About 60 percent of those overdoses were intentional. Among those who took too much acetaminophen by accident, many had chronic back or migraine pain “They had debilitating pain and out of frustration take too much acetaminophen,” Alaniz said.
In another study that he coauthored, 104 patients visiting a general internal-medicine clinic run by the University of Michigan Health System said they had used acetaminophen in the last six months, but almost none could identify the maximum daily dose of either regular or extra-strength preparations of the drug. Nearly 70 percent of patients underestimated maximum doses.
The FDA panel’s recommendation to lower doses made sense, Alaniz said. “You don’t really ever know for sure whether you need to take higher doses,” he said, “so if you can relieve a headache with one tablet, that’s better than two.”
The connection between acetaminophen and liver damage has been on the FDA’s radar screen for years. The consumer-advocacy group Public Citizen has been pushing the FDA to reduce recommended doses of the drug since at least 2002.
Sidney Wolfe, director of Public Citizen Health Research Group and a member of the FDA panel that voted yesterday, said a similar panel first had recommended adding a warning about the risk of liver damage to labels of drugs containing acetaminophen 32 years ago.
The FDA finally insisted on those warnings in April, a precursor to yesterday’s recommendation on dosage. Wolfe said that he wasn’t sure why the action had taken so long, but guessed that industry pressure on the FDA had played a role.