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Novartis Voluntarily Recalls Cold/Allergy Products Containing Phenylpropanolamine In US
SUMMIT, NJ -- November 8, 2000 -- Novartis Consumer Health US is voluntarily withdrawing its phenylpropanolamine (PPA)-containing cold and allergy products from retail store shelves and has begun the process of reformulating all PPA-containing products.
This is in response to an FDA request that companies "voluntarily discontinue marketing any drug products containing phenylpropanolamine" because of an alleged health risk to consumers. The company has taken this action to ensure consumer confidence and trust when using Novartis Consumer Health products.
Novartis Consumer Health continues its belief that phenylpropanolamine, which is used as a decongestant, is a safe and effective ingredient. It has been used by millions of people around the world for many years. In the United States alone, billions of doses of PPA are consumed safely each year. At the same time, the needs and preferences of consumers are a priority for Novartis Consumer Health. The company recognizes that consumers may be concerned or unsure about the use of PPA-containing medications.
The following US cold and allergy products contain PPA and are being withdrawn:
* Tavist-D
* Triaminic DM/Triaminic Cough
* Triaminic Syrup/Triaminic Cold & Allergy
* Triaminicol/Triaminic Cold & Cough
* Triaminic Expectorant/Triaminic Chest Congestion
* Triaminicin
The following products do not contain PPA, and should be considered as alternatives for PPA-containing formulas:
* All TheraFlu products
* Triaminic SoftChews
* Triaminic Cold Cough and Fever
* Triaminic Cough and Congestion
* Triaminic Cold and Night Time Cough
* Triaminic Cough and Sore Throat
* Triaminic Allergy Congestion
* Tavist Allergy
* Tavist Sinus
New formulations of withdrawn Triaminic products using pseudoephedrine as the decongestant ingredient have begun shipping and will be fully available in the US at retail within weeks. Novartis Consumer Health is also currently awaiting FDA approval of PPA-free Tavist Allergy Sinus Headache, which will provide the decongestant benefits of Tavist-D plus pain relief with pseudoephedrine as the decongestant ingredient. This product will be available in the US for the spring 2001 allergy season.
Outside of the US, Novartis will be working closely with local authorities worldwide to ensure a timely transition to PPA-free products as and where appropriate.
Related Link: Novartis Consumer Health.
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