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No Ban on OTC Children's Cold Medicines, FDA Advisers Say

Oct 3, 2008 | Parker Waichman LLP

There will be no ban on children’s over-the-counter cold medicines,  Food & Drug Administration (FDA) advisers said yesterday, despite pleas from pediatricians that the agency take such action. While the FDA panel said that the safety and effectiveness of children’s cold needs more study, they were concerned that an all-out-ban would do more harm than good.

The vast majority of children’s over-the-counter cold medicines were never studied for safety and effectiveness.  The studies used to establish the safety of those drugs were mostly done in adults, and current dosing recommendations for kids are just reduced adult doses.

Earlier this year, the FDA issued a warning advising that over-the-counter cold and cough medicines should not be given to children under two.  The warning came after a 2007 study conducted by the Centers for Disease Control 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.

Most of the injuries caused by children’s cold medicine are the result of accidental overdoses.  In some cases, parents administer two or more drugs to their child – for example, one to treat fever and another for a cough and stuffy nose – without realizing that the medicines contain some identical ingredients. That often results in children receiving a dangerously high dose of an active ingredient.

Some drugmakers have already taken infant versions of the medications of the market. The medicines recalled in October 2007 included 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 were also recalled.

Yesterday, at a day-long hearing to discuss over-the-counter children’s cold medicines, pediatricians pushed the FDA to consider a recall of the products because their safety and effectiveness has never been established.  "When a treatment is ineffective, its risks — unless zero — always exceed its benefits," Dr. Michael Shannon of Children's Hospital in Boston told the FDA panel.

But FDA advisers said they were concerned that without access to these medicines, parents might be tempted to give adult versions to their kids.  "That is a concern for us," said Dr. John Jenkins, who heads the FDA's Office of New Drugs. "We do not want to do something that we think will have a positive impact, only to have an unintended negative. That could be an even worse situation."

However, FDA advisers did say that the medicines need more study, and should not be used in children under 6.  But they also said that children older than 2 could keep taking the medications while studies are undertaken to settle scientific questions about safety and effectiveness.  The FDA is seeking input from doctors, consumers and drug makers before it makes recommendations on using the medicines to treat children under 11, and has not said when it expects to release such guidance.


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