Infant Cold Medication

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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

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Child deaths lead to FDA hearing on cough, cold meds

Devon Mehlberg-Alvarez was Alvarez's firstborn -- and her mother's first grandchild. When he was 4 months old, Devon got a cold. Alvarez took him to the doctor. The doctor told her to give Devon an over-the-counter infant cold and cough medicine. Alvarez followed the doctor's directions and gave Devon the suggested amount.However, a few mornings later when the Bloomington, Illinois, mother checked on her son, something was wrong. "I screamed," says Alvarez, "He wasn't breathing. He was cold." Devon was dead.

Cold medicines for infants pulled amid safety concerns

October 12, 2007 - CVS, Walgreens, Rite-Aid and other drugstores Thursday stopped selling over-the-counter cough and cold medications for children under age 2 after manufacturers asked them to pull the products because of safety concerns.The products are not tainted or defective, and drug makers said there was nothing wrong with the medications when used as directed. But they issued the request amid mounting pressure from physicians, public health advocates and others concerned about deaths of young children linked to overdosing.

Manufacturers Remove Drugs for Infant Cold

WASHINGTON, Oct. 11 — Major makers of over-the-counter infant cough and cold medicines announced Thursday that they were withdrawing their products from the market for fear that they could be misused. The voluntary withdrawal, already under way, affects only products labeled for use in infants, not for use in children 2 and older.

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