By Mark Huffman
ConsumerAffairs.com
July 1, 2009
The FDA advisory committee said the agency should take steps to limit consumers exposure to acetaminophen, the active ingredient in Tylenol. It also called for the ban of Percocet and Vicodin, two popular prescription drugs that combine acetaminophen with a powerful narcotic.
Too much acetaminophen in the blood stream can cause liver damage and can even be fatal. Consumers have been warned for years but the FDA is increasingly concerned these warning are not being heeded.
"I think we have to send the message that there are problems with this medication," Winifred Landis, one of the advisory panel members, said.
The FDA considers painkillers containing acetaminophen to be safe when used as directed, but acetaminophen is the leading cause of acute liver failure in the U.S.
The panel expressed particular concern with Percocet and Vicodin because, as prescriptions, consumers tend to take them over long periods of time. Often, the dosage has to be raised to achieve the same pain relief.
Besides Percocet and Vicodin, the FDA panel recommends banning all prescription pain killers that cointain acetaminophen. At least seven other drugs contain the substance in some amount and many are widely used. Vicodin and its generics are reportedly prescribed more than 100 million times a year in the U.S.
Over the counter products containing acetaminophen would not be banned under the panels recommendation, but their strength would be diluted. The advisory panel suggested reducing the strength of acetaminophen in products like Tylenol from 500 milligrams to 325, and to reduce the daily dosage to less than 4,000 milligrams.
The panel stopped short of reducing the number of pills in each bottle.
Pharmaceutical industry reaction was mixed. A spokesman for Abbot Labs, maker of Vicodin, said if the FDA follows the panels recommendation, the company will follow FDAs guidance.
But Johnson & Johnson, which makes Tylenol, said in a statement that it strongly disagrees with the panels advice. Linda Suydam, president of the Consumer Healthcare Products Association, said other studies have shown that current doses of acetaminophen are safe.
