Johnson & Johnson Withdraws Cough And Cold Drugs For Babies

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Main Category: Pediatrics / Children's Health
Also Included In: Respiratory / Asthma;  Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 11 Oct 2007 - 10:00 PDT

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McNeil Consumer Healthcare, part of Johnson & Johnson, is voluntarily withdrawing some cough and cold OTC (over-the-counter, non-prescription) drugs for infants. The company states that while these drugs are safe and effective when used correctly, there are rare cases when misuse can lead to overdosing, especially in infants under two.

The following products are being withdrawn from the US market:

-- Concentrated Infants' Tylenol® Drops Plus Cold
-- Concentrated Infants' Tylenol® Drops Plus Cold & Cough
-- Pediacare® Infant Drops Decongestant (PSE)
-- Pediacare® Infant Drops Decongestant & Cough (PSE)
-- Pediacare® Infant Dropper Decongestant (PE)
-- Pediacare® Infant Dropper Long-Acting Cough
-- Pediacare® Infant Dropper Decongestant & Cough (PE)

The company stressed that cough and cold drugs for children aged at least two years and single-ingredient pain reliever, and fever reducers, which are expressly labeled for infants do not form part of this voluntary withdrawal - these are still available for parents and caregivers.

Ashley McEvoy, President, McNeil Consumer Healthcare, said "This voluntary action by McNeil Consumer Healthcare is based on the company's long-standing commitment to the appropriate use of medications by parents and physicians. McNeil Consumer Healthcare is committed to providing parents with safe and effective over-the-counter medications that treat their child's cough and cold symptoms. In addition to taking this voluntary action, McNeil Consumer Healthcare, along with our industry partners, supports the Consumer Healthcare Products Association recommendations that were recently submitted to the U.S. Food and Drug Administration (FDA). These recommendations include label changes to OTC cough and cold medicines advising 'do not use' in children under two years of age. Our voluntary action in removing Concentrated Infants' Tylenol® Drops Plus Cold; Concentrated Infants' Tylenol® Drops Plus Cold & Cough; and Pediacare® Infant Drops products from the market is consistent with these recommendations."

The recommendation were submitted by the Consumer Healthcare Products Association. The aim is to reduce misuse which can lead to overdosing.


-- www.jnj.com/home.htm
-- Announcement by the Consumer Healthcare Products Association

Written by: Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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