FDA Expected to Make a Decision on Kids’ Cough Meds

By Anna Boyd
15:10, October 6th 2008
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FDA Expected to Make a Decision on Kids’ Cough Meds

The American Academy of Pediatrics is urging the Food and Drug Administration to demand a recall of over-the-counter cough and cold medicines for children younger than six, arguing that such drugs pose a serious health threat on them. Moreover these medications proved infective in a series of cases while thousands other cases ended up in the emergency room with serious adverse effects such as neurological problems, increased blood pressure and hallucinations. Their number rises to almost 7,000 per year, according to a study released by the US Centers for Disease Control and Prevention in January 2008.

It shouldn’t be forgotten that in October 2007, the FDA received 54 reports of death 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. Most of these deaths occurred in children younger than two.

Given the circumstances, the FDA was supposed to make a decision on the over-the-counter drugs, but instead the agency announced it needs more data on whether these drugs are safe and effective for children between 2 and 6 years old before taking any action. The FDA fears that once these drugs banned, the situations might get even worse, as parents would have to treat their kids with adult medicine, which are much powerful and might have even worse side effects.

“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,” Dr. John Jenkins, who heads the FDA’s Office for New Drugs, said.

On the other hand, the agency offered a range of alternative measures that should remedy the situation, such as stricter labeling and packaging requirements and an awareness raising campaign among consumers.

"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children,” said Baltimore’s City Commissioner of Health, Dr. Joshua Sharfstein.

However, until the FDA makes a decision on what is healthy for our kids, we should not forget that there are better ways to treat their kids when they catch a cold. Although considered old-fashioned therapies, they proved their efficiency in a series of cases. These treatments include humidifiers, saline drops and hydrating fluids such as classic chicken soup. However, if they don’t help your kid get his/her smile back, then it is time for you to pay a visit to your physician. You should not make any decision on your own because what you think it is right for your kid might worsen his/her situation and surely, you don’t want that…Once again, choose wisely when it comes to your loved ones.



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