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Wilmington, North Carolina

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Jean Martin
Jean Martin
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Warning for Parents – Most Drugs Not Approved For Children

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In a study by the University of Michigan C.S. Mott Children’s Hospital National Poll on Children’s Health, 83% of parents stated a belief that the last medication prescribed for their child was approved by the FDA for use in chidren.  Quite to the contrary, less than one-third of presciption medications are approved for use in children.  It makes sense that simply because a drug is approved as safe and effective in adults does not mean that it is safe and effective for use in children.

But how are parents to know?  And why would parents have reason to believe that their child’s doctor is prescribing medication that is not approved for use in children.  94% of the parents polled in this study stated that it was the doctor’s responsibility to inform parents that the drug being prescribed is not FDA-approved for use in children.

But I have to wonder if the doctors really know. I think that the pharmaceutical reps are told to promote off-label use in children everyday.  I think these off-label promotions have gotten so commonplace and so out-of-hand that the doctors are erroneously relying on the words of the marketing arms of big dollar pharma. 

Even when the drug is approved for use in children, have you ever stopped to think if it was truly tested and proven as safe and effective for use in a child?  Every day we are seeing more and more drugs being approved by the FDA for use in children. What scares me is when we see a drug that has been known to cause problems in adults being approved for use in children. 

http://www.sptimes.com/2007/12/16/Worldandnation/A_risky_drug_may_get_.shtml

http://tampabay.injuryboard.com/fda-and-prescription-drugs/zyprexa-on-the-verge-of-being-marketed-to-children.aspx?googleid=229350

Naturally, the dose of medicine, how fast the medicine is processed in the body and side effects of the medicine can be different for children than for adults.  If adults do not tolerate the medication well, then why do we expect different results in children?

I spent several years involved in litigation involving a pharmaceutical product given to pregnant women.  I think the world would be shocked to know that this product was never tested for the effect on the fetus. I think the average person would assume that if a phamaceutical drug can be given to a pregnant woman, then it has been tested and proven as safe for the fetus.  Oh yes, it was approved by the FDA for such use, but it was never truly tested. So instead, innocent unborn children were being used as guinea pigs.  That sickens me.

The morale of the story?  Parents, do your homework.  Don’t simply take at face value the information given to you by the doctor.  Question the doctor.  Find out what he or she knows about the drug being prescribed.  Ask for literature.  Ask your pharmacist what he or she knows.  Ask your pharmacist for literature on the drug.  Use the tools and resources available on the internet.  Be your own investigator.  Don’t let your child be a guinea pig!