CHICAGO 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 on 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 chain pulled the products from its shelves. CVS Pharmacy, the retail unit of CVS Caremark Corp, said it will immediately remove those recalled medicines and store-brand equivalents.
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.
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. 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 on the widely used drugs until it gets input from outside advisers who are to meet October 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.
"At this point, the studies that have been done show no benefit and we do have reported, although rare, bad outcomes," said Dr. Richard Gorman, chair of the American Pediatrics section on clinical pharmacological and therapeutic studies, and a pediatrician in Baltimore.
A group of doctors and public health officials had filed a petition with the FDA voicing concern over the drugs.
"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.
"In the 21st century, it is unacceptable to be marketing medication to infants and children that may not work," Czinn said.
The FDA has been reviewing the issue for over a year, said Dr. Joel Schiffenbauer of the FDA's office of nonprescription products. In August, the agency advised against using the medicines in children under 2 unless a doctor gives specific instructions.
Officials will ask the advisory panel if the products are appropriate in children up to age 12, Schiffenbauer told a conference call with reporters. FDA action could follow the advisory meeting.
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 and antihistamines in children under 6.
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.
(Additional reporting by Kim Dixon and Lisa Richwine in Washington, D.C.)