Several major brands of infant cough medicines are being recalled, not because of product safety concerns, but due to fears parents may be overdosing their children with the mixtures.
Medical Officer for Health, Dr. Kiran Kumar confirmed the products were being recalled in Cayman in a press release Friday.
The recall affects 14 products labelled for use in infants and does not affect cough mixture for children two years and older.
The recall comes amid debate over whether the medicines are safe – let alone effective – when used in young children.
An FDA review has found 54 child deaths related to over-the-counter decongestant medicines in the past four decades and a further 69 reports of children deaths connected with antihistamines, which are used to treat children’s runny noses. Unintentional overdoses were said to be primarily at issue.
Although manufacturers insist the products are safe and effective when used at recommended dosages, US Food and Drug Administration safety reviewers recently suggested that over-the-counter cough medicines for children under six-years-old be banned. On Thursday, an FDA advisory committee is due to meet to consider that proposal and further evaluate the infant medicines.
Linda A. Suydam, President of the Consumer Healthcare Products Association claimed that the medicines are safe and effective when used as directed, adding that most parents are using them appropriately.
‘The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority,’ she said.
But the American Academy of Paediatrics disagreed. It applauded the recall, saying ‘Several studies show that these products are not effective in children under 6 and can have potentially serious side-effects.
‘Dosage guidelines for cough and cold mixtures are based on adult data and thus [are] inaccurate for children.’
The branded cough and cold medicines being withdrawn are:
- 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.