Citizen Petition Calls For Warning Labels On Ibuprofen

POSTED: Tuesday, February 15, 2005

WASHINGTON -- A citizen petition is being filed Tuesday in Washington urging the government to require warning labels on ibuprofen products.

The petition says the products can cause two life-threatening reactions. Stevens Johnson syndrome is a severe disorder of mucous membranes, while toxic epidermal necrolysis is a skin disorder characterized by a blistering and peeling of the top layer of skin.

The action was prompted by a New Jersey woman who said her 3-year-old daughter died in March 2003 after taking Children's Advil. Darlene Kiss said her daughter, Heather, reacted to the drug and developed both Stevens Johnson syndrome and toxic epidermal necrolysis.

Separately, the Kiss family has filed a wrongful death suit against Wyeth Consumer Healthcare, the maker of Advil, for not warning them about possible drug risks. The suit says the company provides this warning in Europe.

The petition comes a day ahead of Food and Drug Administration meetings covering benefits and risks of certain drugs.

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Citizen Petition Calls For Warning Labels On Ibuprofen

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