Children’s Cold and Cough medicines could be dangerous for young children

By Eric Saiontz
Posted October 3, 2007

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The U.S. Food and Drug Administration released a statement earlier this week indicating that children’s cold and cough medicines should contain warnings about use in very young children.  There is little evidence that the medicines are effective in young children, and they could lead to serious injuries, including the possibility of a fatal overdose.

The statement was issued in advance of an FDA advisory panel meeting which is scheduled for October 18-19.  A panel of outside experts will review the safety and effectiveness of the cough and cold medicines available over the counter when they are used in children under 6. 

The FDA indicates that warnings should state that the use of children’s cough and cold products is not recommended for children under 2 years old and that products with antihistamines should not be used until after the child is at least 6 years old.  Currently the labels only indicate that for children under 2 should consult a doctor.
 
A report earlier this year from the U.S. Center of Disease Control and Prevention (CDC) showed about 1,500 cases of serious health problems and three deaths in children under the age of 2 between 2004 and 2005, all of which were linked to the use of cold and cough medicines.  The FDA said it had confirmed over 170 deaths in conjunction with cold medications since 1969, and that most of these were in children under the age of 2.

Currently there are over 800 different types of cold medications on the market.  Makers such as Johnson and Johnson, Wyeth, Novartis AG and Procter& Gamble market many of these products as safe for use in children, even though there is negligible evidence that the medicines are effective in children under 2 years old. 

PRODUCT LIABILITY LAWYERS

If a child under the age of 2 has died or suffered serious injuries which you believe may have been caused by a children’s cough or cold medicine, review the family’s legal rights by requesting a free consultation.