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FDA Considers Restricting Use Of Acetaminophen

June 30, 2009

Concerns are rising over the safety of products with the pain reliever acetaminophen, but on Monday Johnson & Johnson, Procter & Gamble and other manufacturers said they should stay on the market.

The Food and Drug Administration is considering a ban on combination products that are sold to consumers looking for relief from colds or other mild illnesses.

The companies oppose a ban, but they are urging an educational campaign to alert buyers about the risks of liver damage linked to the ingredient.

“We believe there is a clear public health benefit with OTC (over-the-counter) products containing acetaminophen,” said Consumer Healthcare Products Association (CHPA) President Linda Suydam.

Acetaminophen has been linked with liver injury for decades, but FDA officials are worried that the popularity of products that combine it with other medications can lead consumers to overdose.

A 2007 Centers for Disease Control and Prevention report found acetaminophen use was the most common cause of the estimated 1,600 cases of acute liver failure that year, the FDA said.

Experts say alcohol use and liver disease can also increase a consumer’s risk.

A total ban on combination products could cripple sales of acetaminophen-containing products.

The sales amounted to $2.6 billion in 2008 the FDA said, and nearly 80 percent of that stems from combination products sold directly to consumers.

Johnson & Johnson’s McNeil Consumer Healthcare division could feel the greatest impact because the company makes up 27 percent of the sector with its Tylenol brand, as well as its Sudafed and Benadryl products.

Procter & Gamble’s NyQuil, Vicks Formula 44, and other nonprescription medications contain acetaminophen.

Companies that make similar products include Bayer AG, GlaxoSmithKline, Novartis, Perrigo Co, Schering Plough and Wyeth.

The FDA is also considering reducing the amount of medicine sold in packages, lowering the available strengths for over-the-counter products, and adding a black-box warning on prescription medications.

Industry representatives are trying to argue that most overdoses stem from people trying to commit suicide, and that more deaths were seen with prescription versions than over-the-counter ones.

In April, the FDA ordered bolder warnings about the liver damage risk with acetaminophen products to highlight them better for consumers, and companies agreed to comply.

But a further ban on certain products would be “overly drastic,” said Paul Desjardins, a vice president for Wyeth Consumer Healthcare.

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