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have been studied and labeled for pediatric use. The Pediatric Drug Testing
pediatric research that has been done includes some frightening results: of the older drugs just recently being studied in children, 87% were being improperly prescribed. Children were getting medicine that didn’t Harry Shirkey, a medical practitioner, coined the term work at all, were being underdosed, were being “therapeutic orphans” over 40 years ago to describe overdosed, or were being exposed to some possibly how children are overlooked in medical research; his deadly side-effects. Despite the best efforts of the American Academy Dr. Dianne Murphy of the FDA’s Office of Pediatric Therapeutics had this to say, “We found out that you Pediatrics (AAP) and the Federal Drug Administration can’t predict how kids are going to handle things.” The problem is that once a medication has been approved for use in adults, it can legally be prescribed to anyone Guesstimating Medicine
for any reason; despite the lack of pediatric testing or The fact is that the majority of drugs given to children have never been tested specifically for them. Physicians are prescribing drugs based on a “best guess” as to the dosage, efficacy and even safety. It’s becoming clearer to federal regulators and physicians alike that children are not just “small adults”. With their bodies in different stages of development, they process medication differently: sometimes faster, sometimes slower and sometimes turning it into poison. Their body chemistry has not fully matured and yet adult drugs are being prescribed to children on a Dr. Joseph M. Wiley, Chief of Pediatrics at Sinai Off-Label Prescribing
Hospital in Baltimore says, “If you extrapolate from an adult dose to a pediatric dose, you may be right …you The most recent research lists the following top ten drugs being prescribed to children without proper labeling: Albuterol, Phenergan, Ampicillin, Auralgan, Lotison, Prozac, Intal, Zoloft, Ritalin and alupent syrup. The Path to Pediatric Testing
This common practice of prescribing medicine to The road to pediatric drug testing has been a rocky children that has only been tested and labeled for adult one. Nobody wants to use children as guinea pigs, but use is called “off-label prescribing” and it is done by the problem remains that drugs are being given to physicians everyday. A recent study published in the Archives of Pediatrics and Adolescent medicine showed that off-label drugs were used in nearly 80% of The FDA understands that giving medications to children for which there is only adult data available could harm children, considering the fact that they have What needs to be understood is that “off-label” doesn’t dosing concerns and side-effect risks that differ from just mean it hasn’t been properly tested on children, adults. Their latest legislation has made some headway in the battle against the lack of proper labeling; yet it still fails to completely overcome the absence of I N S I D E T H I S I S S U E
research, particularly in the older medications. Page 1 Pediatric Drug Testing and the Aware Parent
This year, the Government Accountability Office said Page 2 Questions to Ask Your Pediatrician
that only one-third of the drugs prescribed for children 2008 The Wellness Family
The Chiropractic Factor

but additionally that it may be prescribed for a purpose Many parents report an improvement in their child’s quality of life after beginning routine, Family Wellness Chiropractic care. A healthy central nervous system Dr. Murphy says that there are about 200 older drugs results in a healthier and stronger immune system, that have been studied in children, but new products which could mean less prescription drugs or other come on the market all the time and their studies, while underway, will take time to complete. That means a lot of untested medications are made available to doctors So, take a moment today to call your Family Wellness Chiropractor and schedule a Chiropractic screening for The Consequences of Off-Label Prescribing
In hospitals and medical offices, pediatricians write off- Questions to Ask Your Pediatrician
label prescriptions everyday with the best of intentions. They make an educated guess about which drug to Before accepting a prescription from your pediatrician, prescribe and what would be an appropriate dosage for be sure to ask the following important questions and a child of this particular weight and age, hoping they’re then thoughtfully consider whether or not to give your right. The problem with this practice is that the children • Would a wait-and-watch approach be advisable in • Worsening of the original complaint • Is this the only treatment available or do I have options that don’t include drug therapy? • What are the side-effects of this drug? Unfortunately, the actual facts in this matter have been • Has the drug been tested for pediatric use? difficult to determine. The British Pediatric Surveillance • Is this the use for which it was intended or are you Unit believes this could be due to many factors, including a reluctance to report, even in an anonymous way, the number of deaths due to off-label prescribing • Can we begin with a smaller dosage and then of drugs to children. However, the European Medicines Agency believes that there is sufficient evidence that harm actually occurs and is under-reported. What it comes down to is whether a pediatrician’s “best baltimoresun.com/news/health/bal-te.medicine16oct16,0,5939770.story guess” as to dosage and efficacy of a drug is going to dukemednews.org/news/article.php?id=10001 be good enough for parents; and whether they should bpsu.inopsu.com/publications/annual_reports/annual-report_2004.pdf be accepting, in blind faith, every prescription written. cabrnoch.cz/media/emea_statement_harmfull_drugs.pdf Dr. Mike and Wellness First Team are dedicated to providing you with the absolute best in family wellness care. Take a moment today to ask your Family Wellness Chiropractor any questions you may have mily’s overall health and wellness. Wellness First Family Chiropractic
7315 Woodbine Avenue
Markham Ontario L3R 3V7
905.477.6578 or 416.318.5939
[email protected]
www.wellnessfirst.ca
2008 The Wellness Family

Source: http://www.wellnessfirst.ca/Newsletters/February%202012-%20Pediatric%20Drug%20Testing.pdf

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PUBLICATIONS – FACULTY 2012-2013 Lutsiv O, Giglia L, Pullenayegum E, Foster G, Vera C, Chapman B, Fusch C , McDonald SD. (2013). A Population-Based Cohort Study of Breastfeeding According to Gestational Age at Term Delivery. The Journal of Pediatrics, doi:pii: S0022-3476(13)00815-9. 10.1016/j.jpeds.2013.06.056. [Epub ahead of print]. Wang L, Sievenpiper JL, de Souza RJ, Thomaz M, Blatz

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