Johnson & Johnson , Wyeth and other makers of infants' nonprescription cough and cold products are recalling certain medicines in the United States because of the danger of overdose, the Consumer Healthcare Products Association said Thursday.
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 2 years old.
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.
FDA reviewers 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. Overdose and drug toxicity were commonly reported in those cases, they said.
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 Oct. 18-19.
Questions have been raised for more than a year 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.
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.
"There are really no good studies demonstrating that these medications work. There are no good studies that provide any information about appropriate dosing if they did work," said Dr. Steven Czinn, chair of the department of pediatrics at the University of Maryland School of Medicine and a signer of the petition sent to the FDA. "In the 21st century, it is unacceptable to be marketing medication to infants and children that may not work."
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.
Medicines that are being recalled from the U.S. market 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 and Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.