Novartis Voluntarily Withdraws PPA-Containing Products Due to FDA Request

Novartis Consumer Health U.S. has announced the voluntary withdrawal of its phenylpropanolamine (PPA)-containing cold and allergy products from retail store shelves. This decision comes after the U.S. Food and Drug Administration (FDA) requested that companies "voluntarily discontinue marketing any drug products containing phenylpropanolamine" due to an alleged health risk. Although Novartis believes PPA is a safe and effective ingredient, it recognizes consumer concerns and is reformulating all PPA-containing products.

Key Takeaways:

• Novartis Consumer Health U.S. is withdrawing its PPA-containing cold and allergy products from retail store shelves.
• The FDA requested a voluntary discontinuation of PPA-containing products due to an alleged health risk.
• Novartis is reformulating all PPA-containing products with pseudoephedrine as the decongestant ingredient.
• The company will provide PPA-free alternatives, such as All TheraFlu products, Triaminic SoftChews, and Tavist Allergy.
• New formulations of Triaminic products have begun shipping and will be available in the U.S. at retail within weeks.

Statistics:

• Billions of doses of PPA are consumed safely each year in the U.S.
• Novartis has begun reformulating all PPA-containing products.
• New products using pseudoephedrine as the decongestant ingredient have begun shipping.
• PPA-free Tavist Allergy Sinus Headache is currently awaiting FDA approval and will be available for the Spring 2001 allergy season.

Sources:

• NewsRx.com
• Medical Letter on the CDC & FDA via NewsRx.com (Copyright 2000)