Infant Cold Medication

SAFETY ALERT:

Infant Cold Medications Recalled

October 11, 2007— Over rising concerns about the safety of over-the-counter infant cold formulas, several manufacturers announced today that they were withdrawing the products from the drugstore shelves.

The recall came one week before the Food and Drug Administration plans to hold a hearing on the safety of OTC cough and cold medications for children. The FDA hearing is in response to doubts about the effectiveness of these products and mounting evidence the medications can cause serious complications, including severe hallucinations and agitation, seizures, high blood pressure, and heart and breathing problems that can be fatal in rare cases.

An FDA review prepared for next week's meeting describes dozens of cases of convulsions, heart problems, trouble breathing, neurological complications and other reactions, including at least 54 deaths involving decongestants and 69 deaths involving antihistamines. Most of the complications reported involved children younger than 2.

The recalls were announced by the drugs’ manufacturers, McNeil Consumer Healthcare, Novartis Consumer Health and Wyeth.  This recall affects some 14 products, including:  Dimetapp Decongestant Plus Cough Infant Drops, Tylenol Concentrated Infants' Drops Plus Cold, and Robitussin Infant Cough DM Drops. 

Consumer Healthcare Products Association, a trade group for the makers, released the following list of the products that have been recalled:

• 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
  

Note - Do not change medications without first consulting your doctor.

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