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Over-the-Counter Infant Cold Medicine Recall Sparked by Safety Concerns

Oct 11, 2007 | Parker Waichman LLP

Some over-the-counter infant cough and cold medicines are being recalled by their manufacturers because of recent concerns about the safety and effectiveness of such drugs.   The move comes after two separate studies by the Centers for Disease Control (CDC) and the Food & Drug Administration (FDA) found that hundreds of toddlers had been injured, and even killed, by over-the-the-counter cough and cold remedies.  Those studies had increased calls for such medications to be banned, and many experts expected the FDA to come down hard on over-the-counter infant cold medications during a special meeting later this month.

The Consumer Healthcare Products Association, a trade industry group,  announced the move this morning, saying in a statement that the dangerous medications were being pulled because  “there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."  Among the over-the-counter medications coming off the market are Johnson & Johnson’s Tylenol Plus Cold, Novartis AG's Triaminic Infant & Toddler Thin Strips Decongestant, and one product sold by Wyeth under its Robitussin brand. Pediacare, Dimetapp and Little Colds brand products are also being recalled. The voluntary recall does not affect over-the-counter cold and cough medications marketed for older children.  

Prior to this recall, there were about 800 different over-the-counter cold medications sold in the US for use in young children.  Amazingly, the FDA had never previously studied the safety or effectiveness of these products in children.  Years ago, the agency had concluded that if over- the-counter cold preparations were safe and effective for adults, then smaller doses would be safe and effective for infants.

But two new studies proved that assumption wrong.  Earlier this year, research conducted by the CDC found that between 2004 and 2005, 1,500 children under the age of 2 had been injured by common over-the-counter decongestants and antihistamines.  A second study by FDA safety reviewers reached similar conclusions.  Their research found that from 1969 to 2006, at least 54 children died after taking over the counter decongestants, and 69 died after taking over-the-counter antihistamines.   And the FDA safety reviewers found little to convince them that over-the- counter cold remedies marketed for use in infants did anything to relieve cold symptoms.

The FDA safety reviewers actually recommended a ban on all over-the-counter infant cold medications.   The FDA was set to consider those recommendations later this month.   At first, the Consumer Healthcare Products Association had been on record opposing such a ban, and proposed the addition of warning labels to over-the-counter medications saying that the products should not be used in children under 2.  But, as evidence continued to show that over-the-counter infant cold remedies did more harm than good, it was becoming obvious that the Consumer Healthcare Products Association was fighting an uphill battle to keep the medications on the market.   

Parents with infants and toddlers suffering from colds might be perplexed to find that some popular medications are no longer available to them.  However, physicians say there are more effective – and far safer – ways to treat these ailments in children under 2.  Parents of sick infants can use vaporizers or hydrators, saline nose drops, rubber nose bulbs, and chicken soup and other fluids to keep a child comfortable.   All of these remedies will ease cold symptoms, and none of them pose any danger to an infant.


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