FDA Mulling Restrictions on Tylenol, Other Acetaminophen Products

The Food and Drug Administration is meeting beginning today to discuss possible ways to reduce overdoses of acetaminophen, the pain-killing drug found in popular brands such as Tylenol, Excedrin, Theraflu, and NyQuil.

As many as 56,000 people are admitted to emergency rooms across the United States each year due to overdoses of acetaminophen, the FDA said. Acetaminophen drugs have been used for more than 50 years to treat headaches, minor muscle aches and pain, and other ailments. It is one of the most widely used drugs in the U.S., with more than 28 billion doses sold in 2005 alone, according to the FDA.

But too much of the drugs can cause severe liver damage, officials caution.

A Leading Cause of Liver Failure

The misuse and abuse of acetaminophen continues to be a leading cause of liver failure, despite repeated efforts to educate the public about the dangers of the drugs, the FDA said. Most of the products carry a recommended maximum daily dosage of four grams, which is just below levels that can result in liver damage, so there is a narrow margin for error in using the drugs.

Today, the FDA kicked off a two-day meeting designed to illicit feedback from doctors and medical industry experts about what should be done to reduce the rate of accidental overdoses of acetaminophen. Part of the problem is that too many consumers believe such tried-and-true medications such as Tylenol are safe and cannot result in severe injury, the FDA said.

Advisory Panel Meeting This Week

The FDA is asking medical experts to advise the agency on whether Tylenol and other acetaminophen-based products – both prescription and over-the-counter — should carry prominent “black box” warnings on the packaging to warn users of the risk of liver damage and other injuries. The panel might also recommend lowering the maximum daily dosage or even go so far as to remove some acetaminophen products from the market in an effort to protect consumers.

While the FDA is not required to follow the advice of its advisory panels, it most often does. A formal decision on how the FDA will handle Tylenol and other acetaminophen-based pain products could be made in the coming weeks and months.

Combo Products Being Examined

Particular attention is being paid to products such as NyQuil and Theraflu, which combine acetaminophen and other drugs. According to the FDA, such products were involved in just five of the 72 deaths reported with acetaminophen in 2005. There were 27 deaths involving single-ingredient over-the-counter acetaminophen products and 40 associated with prescription acetaminophen products, the FDA said.

Drug Makers Oppose Restrictions

Drug-industry advocacy groups are already digging in their heels and preparing for a fight over acetaminophen products.

“These products provide consumers with effective pain relief and are safe and effective when used according to labeled direction,” the Consumer Healthcare Products Association said in briefing documents posted online.

Johnson & Johnson, the maker of Tylenol, said the advisory panel should be careful to restrict acetaminophen products, which could force patients to start taking nonsteroidal anti-inflammatory drugs (NSAIDs), another class of drugs which carry their own set of severe risks, including gastrointestinal bleeding and kidney injury. Aspirin and Advil are top names in NSAIDs.

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