FDA Explains Why You Should Report Child Medication Side Effects

Posted on February 19, 2013

If you’re a parent, then it’s up to you to do whatever is necessary to ensure the safety of your child or children.  But did you know that there’s something you can do to protect other kids all across the nation?

When children suffer side effects from medication or a medical device, a parent’s first reaction is to take the kid to a doctor, an advisable move.  But what you don’t want to do is forget about that reaction after the side effect recedes or the event is in your rearview mirror.  The Food and Drug Administration has adverse event reporting procedures in place to ensure that relevant information about medical side effects reaches the necessary authorities.  In a new report, the FDA explains how to go about reporting adversity through MedWatch and also details why this can save lives.

The FDA provides an example from six years ago.  At that time, the organization began to hear from consumers whose children experienced side effects upon making incidental or direct contact with topical testosterone gel.  Intended to increase testosterone levels in men, the item was shown to be so potent that kids could experience the effects of the gel just by making contact with the skin of the older user.  A series of reports prompted the FDA to work with manufacturers to create new warnings and usage procedures designed to protect kids from harmful side effects.

Not all side effects get reported in this manner, and in fact the FDA worries that much of the adversity which occurs across the country never gets related to them.  Even though 900,000 reports of a side effect came into the FDA last year, a scant 45,000 or so of those incidents involved persons under the age of 18.

But as the FDA explains, one report can trigger an investigation that could lead to future preventative actions.  Pediatric clinical trials typically don’t use as many patients as regular trials, and thus the full effect of a drug might be hidden until the item becomes available around the country.

So take reporting seriously to protect your children and the children of other concerned parents.  Perhaps the best way to begin is by going online to the MedWatch Reporting website (you can also use the mail, a fax, or place a phone call).  Start by supplying the FDA with information about the product, and be as specific as possible in terms of dosage, administration procedures, and anything else you can think of.  Explain what happened to the child, and relate his or her age.  Detail other important factors, such as prior medical conditions or other drugs in your household.  Finally, tell the FDA what happened after the drug was stopped or medical treatment was sought.

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