Infant cold medicines recalled for overdose risk

October 11, 2007

Chicago - Major makers of infants' nonprescription cough and cold products are many medicines in the United States because of the danger of overdose.

Novartis and Prestige Brands Holdings are recalling their oral infant cough and cold medicines, as well, because data show that when the medicines are misused, it can lead to overdose, especially in children under the age of 2 years.

At least one U.S. pharmacy pulled the products from its shelves. CVS Pharmacy said it will immediately remove those recalled medicines and store-brand equivalents.

A spokeswoman for Consumer Healthcare, a trade association representing the makers of over-the-counter medicines, said overdoses have led to death and serious injury in rare instances, but stressed that the medications are safe when used as directed.

The Johnson & Johnson products being recalled include: infants' Tylenol Drops Plus Cold; Concentrated Infants' Tylenol Drops Plus Cold & Cough; Pediacare Infant Drops Decongestant; Pediacare Infant Drops Decongestant & Cough; Pediacare Infant Dropper Decongestant; Pediacare Infant Dropper Long-Acting Cough; and Pediacare Infant Dropper Decongestant & Cough (PE) products.

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 for use on the widely used drugs until it gets input from outside advisers on October 18-19.

Questions have been raised for more than a year about the safety of the use of nonprescription cough and cold products in children and whether the benefits justify any potential risks, especially in children under 2 years of age.

Although the medications aren't dangerous if proper dosage is followed, parents who have the products in their medicine cabinets should throw them away, NBC's chief medical editor Dr. Nancy Snyderman told MSNBC Thursday. The danger comes when parents confuse the droppers that come with infant medicines with larger medicine cups that are used for doses for older children and adults.

"Those droppers really give you concentrated medicine. as you know. If you give your infant a drop or two, you think in the back of your mind, that doesn't seem like very much, maybe an extra little drop will be OK. That's where the problem comes in," Snyderman said.

Safety experts for the U.S. Food and Drug Administration have urged the agency to consider a ban on these medicines for children under the age of 6 years.

A group of doctors and public health officials had filed a petition voicing concerns that the drugs were risky and not effective for children.

FDA reviewers 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.

Many say there is little evidence that these medicines are effective in such young children anyway and are calling for mandatory warning labels that say the medicines should not be used in children under 2 years of age.

FDA spokeswoman Susan Cruzan said the action by the drugmakers was independent of the agency.

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