The Advisory Committee for the FDA voted Wednesday to recommend the removal of prescription drugs, such as Vicodin and Percocet, that contain acetaminophen from the market, and to lower the recommended 24-hour dosage on over-the-counter (OTC) pain killers, such as Tylenol and Excedrin, that also contain the drug acetaminophen.
The FDA estimated that the overdosing of acetaminophen
is responsible for 640, more than half of which are unintentional, cases of acute liver failure each year.
Based on that, the FDA advisory panel voted 21-16 to lower the maximum daily dose of OTC acetaminophen, which is currently 4 grams,
or equivalent of eight pills, of a drug such as Extra Strength Tylenol. The panel did not recommend another maximum daily dose. The panel also voted 24-13 to limit the maximum single dose of a pill containing acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams. The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen, such as an Extra Strength Tylenol, available by prescription only.
However, the FDA also says that acetaminophen is safe
when taken as directed. "It's important to Abbott (the makers of Vicodin) to balance patient safety and treatment options, said DeAnna DuBose, senior manager of Abbott Public Affairs. "Once the FDA makes a final determination, Abbott will respond to the agency's guidance."
As for the idea of remaking Vicodin without acetaminophen, DuBose said it's too early to speculate that idea just now.
McNeil Consumer Healthcare, the manufacturer of Tylenol, strongly disagrees with the committee's recommendation, a McNeil representative said. "McNeil Consumer Healthcare believes that this recommendation is likely to lead to more serious adverse events as consumers shift to other over-
the-counter products such as non-steroidal anti- inflammatory drugs (NSAIDS) in search of pain relief," the representative added. "We believe the FDA needs to take these key considerations into account as they deliberate on these advisory committee recommendations and before
they make any final decisions."
McNeil Consumer Healthcare, which is a subsidiary group of Johnson & Johnson, issued a letter to consumers to maintain confidence in their product.
The letter ensures consumers that Tylenol is the safest pain reliever people can take, when used as directed. They believe the problem is when people take more than the
recommended dose.
A McNeil Consumer Healthcare representative said the company is looking forward to cooperating with the FDA as it considers the recommendation of the Advisory Committee and moves toward a final decision.
The FDA has already made some changes to medicines
containing acetaminophen. They issued a "rules and regulations" document in April for all drugs that contained acetaminophen. It stated that all product boxes were to include a warning label with information on severe liver injury, the ingredient name, acetaminophen, would be
highlighted or in bold, the statement "See new warnings information" would be highlighted or in bold for 12 months following publication of the rule and alcohol warning as part of liver warning required.
Consumers should know that the FDA is not required to
follow the recommendation of the Advisory Committee.
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