Recall on Children's Cold & Cough Medicine

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FDA NEWS: January 17, 2008.

FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur.

FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed.

FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory and a previous MedWatch alert dated January 12, 2007, regarding this issue.

FDA Website link:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough

Johnson & Johnson Wyeth and other makers of nonprescription cough and cold medicines issues recall on these products due to possible overdose concerns in children under 2 years of age.

Brands that are recalled include:

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) products;

Dimetapp Decongestant Plus Cough Infant Drops;

Demetapp Decongestant Infant Drops;

Little Colds Decongestant Plus Cough;

Little Colds Multi-Symptom Cold Formula;

Robitussin Infant Cough DM Drops;

Triaminic Infant & Toddler Thin Strips Decongestant and Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.

Overdose concerns:

Even though the The FDA recommends that over-the-counter cough and cold medicines that have decongestants and antihistamines should have labels with instructions illustrating that they should not be given to very young children.

U.S. Government officials are reviewing the safety and efficacy of a number of over-the-counter children’s cough and cold medications in order to determine if they pose a threat.  Many healthcare professional groups maintain that these drugs no only do not treat the symptoms of many common children’s ailments, but can also be dangerous to a broad cross section of young people.  In fact, the Centers for Disease Control and Prevention reported that more than 1,500 toddlers and babies had to receive emergency room treatment over two years due to these kinds of drugs.

In a response to a petition filed by the Baltimore city officials on Thursday, March 22, Dr. Charles Ganley, director of the Food and Drug Administration’s Office of Nonprescription Drug Products, stated, "We have been looking at this issue internally with regard to the safety and efficacy of the use of these products in children."  The new review covers decongestants, antihistamines, cough suppressants and expectorants.

Although the warning labels on products such as Tylenol Plus Cold & Cough and Infant Triaminic Thin Strips explicitly state that they parents should consult a doctor before giving medicine to children younger than two years old, the packaging of the same drugs uses languages such as “infant” or “baby” and also often portrays children of a much younger age than the recommended by the warnings.

In Maryland, where many of the sponsors of the petition reside, almost 900 children four years and younger suffered overdoses of cold medicines in 2004, and in Baltimore these products were linked to the deaths of at least four children over the past five years. 

Startlingly, there have never been any conclusive studies that children’s cough and cold medications have any effect on the myriad common colds that strike children each year.  This, along with the startling injury rate, promoted concerned citizens to speak up and demand new safety precautions for these common over-the-counter drugs.

If your child has been been harmed or has overdosed from taking any of the above listed medicines, please contact our defective drug lawyer today for a free review of the situation. Attorneys working to make sure these companies are issuing safe medicines.

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