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What do WE know about children’s medications? Almost nothing!

whatdoweknownothing.jpgGuess what? When it comes to children’s medications, we are actually clueless. And ?we? includes not only us parents, but also the doctors, and the pharmaceutical companies themselves!!! This is according to a report in the Washington Post.

Although drug testing has been done rigorously during the past 2 decades, there is still a big gap in scientific and general knowledge of how medications affect children. The recent reports about serious side effects of OTC drugs brought to light this shortcoming. One major problem is that most medications are tested in adults only and it is simply taken for granted that children are smaller versions of the human adult. Unfortunately, recent observations show that is not the case.

Now, you may ask, how can drugs not tested in children be given to children? The reasons are many, some are valid, some aren’t.

  • Drug authorities and drug companies would rather not use children (understandably enough) as test subjects in clinical trials that test drugs for their effectiveness and safety.
  • Drug companies are not spending enough money on pediatric drug research. The pediatric drug market is of low priority ? what with increasingly low birth rates and an increasingly aging population.
  • There are no test subjects available. Let’s face it. Very few parents would give consent to use their kids in clinical trials. Maybe as a last resort for terminally ill patients but not in cases of testing common cold and cough drugs.

Upon the urging of drug regulation authorities, pharmaceutical industries have conducted studies on over 200 drugs which were initially untested for pediatric use but generally prescribed for children. A priority list of drugs that need to be tested has been prepared and these include medications to treat common children ailments such as infections, asthma, and hyperactivity. However, anti-cancer drugs need to be tested as well.

The results of these studies are pretty disturbing and can be summarized as follows:

  • Some drugs that work in adults do not work in children.
  • Some drugs are being prescribed to children at the wrong dosage.
  • Some drugs are causing unexpected side effects, some of which are life-threatening.

Drug regulatory bodies like the US FDA and the European Medicines Agency (EMEA) are now requiring drug companies to test all new drugs for pediatric use before marketing approval. However, what about those drugs previously approved?

Many companies are turning to developing countries for clinical trial testing. Sadly, many parents in these countries are willing to give consent to conduct tests on their children for economic reasons. What is scary is that drug testing regulations in these countries, if existing at all, are rather lax (at best). We can only hope that the big pharmas act responsibly and don’t exploit these people. Remember the film ?The Constant Gardener??


Washington Post, 23 November 2007

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