Makers of Dimetapp, Pediacare, Little Colds, Triaminic, Robitussin, and Tylenol are pulling their infant cold medicine products from stores. The medicine makers claim that the medicines are safe for use, but they were concerns that parents could misuse the medicines by accidentally overdosing their children. The voluntary withdrawal follows the Food and Drug Administration’s recommendation that all over-the-counter cold and cough medications for children younger than two years of age be banned.
The Consumer Healthcare Products Association also is recommending the ban. However, many medicine makers are continuing to manufacture and market these types of products and make them available in the market.
More than 800 over-the-counter pediatric medicines for coughs and colds are available. Before July 15, at least 41 million units had been sold in the U.S. While the industry claims that these medicines are safe when administered properly, others are worried that they could be dangerous.
Between 1969 and 2006, 114 children died from taking cough or cold medicines. Children also sustained injuries from taking too large a dose. However, one case at the Poison Control Center of the Children’s Hospital of Philadelphia reported four incidents of lengthy hallucinations by kids that had taken the recommended dose.
The FDA says there are 69 reported deaths of children who had taken antihistamines when they had runny noses. It also cited 54 deaths caused by decongestants sold over-the-counter. In Maryland, 900 children younger than four years of age reportedly overdosed on infant cough and cold medicine.
List of Medicines Pulled from the Marketplace:
Tylenol
• Concentrated Infants’ Drops Plus Cold & Cough • Concentrated Infants’ Drops Plus Cold
Robitussin
• Infant Cough DM Drops
Little Colds
• Multi-Symptom Cold Formula • Decongestant Plus Cough
Dimetapp
• Decongestant Infant Drops • Decongestant Plus Cough Infant Drops
Triaminic
• Infant & Toddler Thin Strips Decongestant Plus Cough • Infant & Toddler Thin Strips Decongestant
Pediacare
• Infant Dropper Decongestant & Cough
• Infant Dropper Decongestant • Infant Drops Decongestant • Infant Dropper Long-Acting Cough • Infant Drops Decongestant & Cough
Baltimore health commissioner Joshua Sharfstein says that it is unreasonable for medicine makers to claim that products are safe for use when taken as suggested because they don’t offer recommended doses for children younger than age two.
Side effects associated with over-the-counter medication can include irritability, sedation, allergies, and heart abnormalities.
Dr. Sanjay Gupta from CNN recommended that infants with coughs and colds be treated with saline nose drops, hydrators, chicken soup, vaporizers, and fluids.
Pharmaceutical companies are supposed to ensure that the over-the-counter and prescription drugs that they make for users are safe for use when taken properly. They are also supposed to provide proper instructions and warnings on their labels. Failure to do any of this can turn a common over-the-country medication into a dangerous drug and lead to injuries or deaths. The pharmaceutical company that manufactured the dangerous medication can be held liable for personal injury or wrongful death.
Makers pull cold medicines sold for infants, CNN.com, October 12, 2007
Makers Pull Infant Cold Medicines, New York Times, October 11, 2007
Related Web Resources:
Consumer Healthcare Products Association
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