Off Label Marketing For Children
The term “off label” in the drug industry indicates a drug that is used for a purpose or a consumer group for which it has not been clinically approved. Off-label marketing is being used significantly today for a new consumer group to the pharmaceutical group to the industry, that being children. Unfortunately, prescription procedures and information for children using drugs that are typically prescribed for adults is either unavailable or scarce. Unfortunately, many doctors simply rely on utilizing size as a dosing method for prescription drugs used in children. In other words, if a child weighs 50 lbs., for example, some doctors will just divide an adult weight in thirds or quarters and prescribe this dose for a child, assuming that children are merely smaller versions of adults. Unfortunately, children’s systems physiologically are significantly different than adults, and obviously, developmentally, their bodies are significantly different as well.
Believe it or not, the FDA has coerced drug manufacturing companies to conduct necessary studies on more than 200 drugs which these manufacturers are attempting to have prescribed to children. Unfortunately, over two thirds of the drugs children are prescribed are untested. The ones that have been tested demonstrate the following statistics: One fifth of the drugs that are effective when used on adults are totally ineffective in children; one fifth are being prescribed in the wrong dosage when used in children; and one third of these drugs cause unexpected side effects, some which were fatal.
Some of the reasons for this are that children have a higher metabolic rate than adults and therefore tend to process the drugs more quickly. Unfortunately, since children’s bodies are metabolizing quickly, they are also growing quickly and many of these drugs have the tendency to stop physical growth or impair cognitive development.
According to Robert M. Ward, the Director of Pediatric Pharmacology at the University of Utah, “they don’t want their children to be thought of as a guinea pig or a rat in a study. What I try to explain is that they are receiving a medication that hasn’t been studied, then they are essentially participating in a study anyway.” Dr. Ward made this comment relative to parents who were concerned about their children being involved with drugs studies.
A number of years ago I wrote an article regarding drug studies which wasn’t extremely flattering to certain doctors involved in this program; however, it is important for you to recognize that a portion of a drug study is occurring after the drug is already released on the market. In other words, adverse event reporting and mortality rates related to a specific drug are compiled and this often times is why certain drugs are pulled from the market or required to have black label warnings printed on their packaging.
So, when using any drugs with a developing child, it is extremely important that you as a parent use extreme caution and recognize that even prescription drugs, let alone over-the-counter drugs have not necessarily been tested for use in children.
Many conditions for which these drugs are being utilized by well intentioned parents are self-limiting, such as fevers, colds and flu-like symptoms. A child’s system, when supported correctly, will be able to fight these conditions off and the symptoms will fade relatively quickly. So use caution and be judicious in dosing your children with these drugs.
I thank you for your readership and look forward to bringing you more information that will assist you in your quest for health and wellness. For more information about our previous articles, visit the Health Hintstm section of this website. In order to receive our monthly newsletter and any other health related information we send out to our subscribers, email us at upchirocenter1@verizon.net and we will place you on our email list to receive the latest information regarding your health and wellness. We are now up and running in the Nutritional Wellness Center. We will be emailing information regularly regarding this to our email subscribers as well.