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FDA FINALLY Says NoTo Cold Remedies for InfantsBut Agency Fails to Pull Drugs from Market

Posted Sep 11 2008 5:53pm

It’s taken years, but the Food and Drug Administration is finally issuing an advisory that parents should NEVER give cough and cold medicines to children under the age of 2, reports The New York Times. The FDA had announced in March it would review the drugs.

The problems?

  • The cough medicines are being “blamed for hundreds of adverse reactions and a handful of deaths in children under the age of 2,” writes the Times.
  • Some of the drugs contain ingredients known to cause neurological problems such as hallucinations, increased blood pressure, arrhythmias caused by racing hearts and death.
  • The drugs were tested on adults and not children, whose immature bodies often react differently then adults.
  • Testing standards have become much more rigorous since these drugs were approved for the general public.
  • Adults often misread or fail to properly follow instructions, resulting in overdoses.
  • Mixing products also has resulted in overdoses.
  • Some children have been injured even by the recommended dose.

But the biggest problem, according to some experts, is the drugs allegedly don’t work. “Unless convincing evidence shows that these medications are effective for children, their easy availability to families should be re-examined,” Dr. Ian M. Paul, a pediatrician at Penn State Children’s Hospital in Hershey, Pa., tells the Times.

But why didn’t the FDA just ban the drugs for all kids? Will these cough medicines suddenly become better days after my child turns 2? I think not. The FDA has left room to discuss the issue further in October.

Worse, the FDA has only issued an advisory. It hasn’t actually pulled the drugs from the market. Why? My guess is this: $$$$$$

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