Cough It Up: No OTC Meds For Kids Under 2
1 CommentBy Ed Silverman // October 11th, 2007 // 6:56 am
Major drugmakers plan to stop selling some versions of OTC cough and cold meds aimed at children younger than 2 years old, a move that comes as the products are under scrutiny from federal regulators, The Wall Street Journal reports (subscription required).
The Consumer Healthcare Products Association, a trade group that represents OTC makers, is expected to announce the voluntary change as soon as today, the paper writes. In documents submittted previously to the FDA, the group had only supported new warnings that would say “do not use” in children younger than 2.
Among the meds likely to be affected are the infant version of Johnson & Johnson’s Tylenol Plus Cold, Novartis’ Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand, the Journal reports. Other companies could also be involved. To see a partial list of drugs being recalled, please click on ‘read more’ and scroll to the bottom of the screen.
On Sept. 28, the FDA released reviews of the meds by its staffers and other groups. Agency safety reviewers said their analysis suggested use of some drugs was associated with serious side effects and some deaths in patients younger than 6. They also noted that the drugs haven’t been proven to work in young children, the Journal reminds us. The FDA noted, however, that the agency hadn’t come to a final conclusion about how to deal with the products.
The FDA said in the documents that it had received 54 reports of deaths in children linked to decongestants containing the ingredients pseudoephedrine, phenylephrine and ephedrine from 1969 to Sept. 13, 2006, and 69 reports of deaths linked to antihistamines with the ingredients diphenhydramine, brompheniramine and chlorpheniramine. The agency said the bulk of the reports were in children younger than 2. Some of the deaths occurred in children who received overdoses, and an FDA official said the agency worried that parents might be inadvertently giving young kids multiple medications that contained the same ingredient, the Journal continues.
The agency plans to hold an advisory committee meeting on Oct. 18 to examine the safety and effectiveness of the OTC meds in young children, focusing on kids younger than 6. In a letter that became public along with the FDA’s reviews, the paper writes, the American Academy of Pediatrics recommended the medications’ labels note that they have “been shown to be ineffective” in children younger than 6, and that “serious adverse reactions, including but not limited to death, have been reported with its use, misuse and abuse.”
The new exam was sparked by a petition from a group of doctors to the FDA in March. The petition called on the agency to change the labeling of over-the-counter cough, decongestant, antihistamine and cough-and-cold products to say that they “have not been found to be safe or effective in children under 6 for treatment of cough and cold.”
In the US, J&J is recalling: Concentrated Infants’ Tylenol Drop 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. Wyeth is withdrawing Dimetapp Decongestant Infant Drops. Novartis is yanking Triaminic Infant & Toddler Thin Strips. And Prestige Brands is pulling Little Colds Decongestant Plus Cough.
M R
I am a pharmacist. I deal with this problem every day. The problem I see is in the marketing of these products. Caregivers and parents are so in tune to the Tylenol or Pediacare brand names that they do not look closely at the ingredients. Multi-symptom products are thought by many consumers to be “the best” or “the strongest”. I tell patients every day that they need to treat the specific problem. As well as marketing problems, infant concentrated formula’s seem to be a huge problem. Each product has a different dosing apparatus. Some products go by the ml or cc and some by the dropper or dropperful and others by teaspoon or teaspoonful. This can and has become a huge issue for young children are overdosing or being overdosed unintentionally by mis-education. I hope the FDA can come up with some sort of “reasonable” solution. I would hope the board would seriously consult with the Boards of Pharmacy and Associations of pharmacy to help with this problem.