Drug Companies Voluntarily Withdraw Cough and Cold Medicines for Babies

WASHINGTON, Oct. 11 -- Makers of 14 over-the-counter cough and cold medicines labeled for use in children younger than two said today they are voluntarily pulling their products from store shelves.

The announcement came just a week before a scheduled FDA hearing to examine the safety of pediatric cough and cold remedies. The action does not include products labeled for use in children age two or older.

In a statement Linda A. Suydam, D.P.A., president of the Consumer Healthcare Products Association, said the withdrawal should not be construed as an admission that the products are unsafe.

"It's important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," she said. The reason for the voluntary withdrawal "is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."

The products slated for withdrawal are:

• Dimetapp Decongestant Plus Cough Infant Drops
• Dimetapp Decongestant Infant Drops
• Little Colds Decongestant Plus Cough
• Little Colds Multi-Symptom Cold Formula
• Pediacare Infant Drops Decongestant (containing pseudoephedrine)
• Pediacare Infant Drops Decongestant & Cough (containing pseudoephedrine)
• Pediacare Infant Dropper Decongestant (containing phenylephrine)
• Pediacare Infant Dropper Long-Acting Cough
• Pediacare Infant Dropper Decongestant & Cough (containing phenylephrine)
• Robitussin Infant Cough DM Drops
• Triaminic Infant & Toddler Thin Strips Decongestant
• Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough
• Tylenol Concentrated Infants' Drops Plus Cold
• Tylenol Concentrated Infants' Drops Plus Cold & Cough

Suydam said her group has submitted revised labeling language to be viewed at next week's two-day FDA advisory panel on oral over-the-counter pediatric cough and cold medicines.

At present, pediatric cough and cold medicines that are not specifically labeled for use in children younger than two advise care givers to "ask a doctor" before using the medicine in babies. The drug companies recommended striking that wording and substituting a flat "do not use" admonition. Suydam said her group has asked its members to voluntarily make this label change on all pediatric over-the-counter cough and cold medicines.

She said the group also had plans for a "multi-year national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse, and pharmacist organizations."

When the FDA released briefing materials for the advisory meeting, which is scheduled for Oct. 17 and 18, several news stories reported that FDA planned to ban over-the-counter cough and cold medicines for babies. Confusion created by those reports prompted the FDA to issue a press release aimed at clarifying the issue.