Johnson & Johnson and other makers of infants' non-prescription cough and cold products are voluntarily recalling certain medicines in the United States because of the danger of overdose, according to the the Consumer Healthcare Products Association.
A spokeswoman for the Consumer Healthcare Products Association, a trade group representing makers of over-the-counter medicines, said overdoses have led to death and serious injury in rare instances, but stressed the medications are safe when used as directed, according to a Reuters report.
U.S. Food and Drug Administration reviewers have said that from 1969 through 2006 the agency received 54 reports of deaths with decongestants and 69 with antihistamines.
Most were in children younger than 2.
And the U.S. Centers for Disease Control & Prevention reported earlier thsi year that more than 1,500 toddlers and babies wound up in emergency rooms over a two-year period and three died because of bad reactions to cold or cough medicine. The U.S. Centers for Disease Control and Prevention warned parents not to give common over-the-counter cold remedies to children under 2 years old without consulting a doctor.
FDA reviewers have recommended that over-the-counter cough and cold medicines that contain decongestants and antihistamines should come with new instructions saying they are not recommended for very young children.
The FDA has not made a final decision on whether to change the warnings or instructions on the widely used drugs until it gets input from outside advisers who are to meet Oct. 18-19.
Questions have been raised about the safety of nonprescription cough and cold products in children and whether the benefits justify any potential risks, especially in children under 2 years of age.
FDA reviewers have said the product labels "should include prominent language to describe the risk of overdose in children." They also recommended dropping the statement on many over-the-counter remedies urging parents to "consult a physician" about use of decongestants in children under 2 years old and antihistamines in children under 6 years old.
To read the full Reuters report visit: http://www.reuters.com/article/domesticNews/idUSN1133248720071011
Medicines that are being voluntarily 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
Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.