KIDS
February 1, 2010

Making Prescription Medicines Safe for Children

Warnings about the effects of prescription drugs on children are often not reported accurately...

When it comes to medication dosing, children are not just small adults. As children mature physically and biochemically from infancy to young adulthood, their reactions to medications change. What may be the correct drug dose at one stage of life, may be too much, too little, or even completely ineffective at another.

The effectiveness and side effects of medication are influenced by the ability of the body to absorb the medicine, to process it into active components, and to eliminate it safely from the system. If a drug isn't metabolized properly, toxic amounts may build up in the system causing unwanted complications. If it isn't absorbed or broken down properly, the active components may never reach the target organs intended for treatment. Some medications may affect a child's normally developing organs and cause short and long−term damage. Additionally, although many childhood illnesses are similar to those experienced in adulthood, the immaturity of the developing body systems, including the immune system, may alter the manner in which the symptoms are best treated.

A More Aggressive Approach to Safety

So how do doctors find out what is effective, safe, and sufficient medication for their patients? Typically when drugs are developed, they are tested on animal models, and, once they are determined to be appropriately safe, they are tested on humans. Drug manufacturers use these results to provide clinicians with information about dosing and side effects, both common and uncommon. Once drugs are on the market, ongoing databases are maintained about their usefulness and side effects that were not seen initially, but may become more evident as more and more patients use the medicine.

If discovered to be too risky for continued use, drugs are removed from the market. However, most medications have not been rigorously tested for use in children. Without such investigation, clinicians have no guidelines for their safe use, and many young patients are being deprived of potentially effective treatments for their conditions.

Most medications have not been rigorously tested for use in children...[so] clinicians have no guidelines for their safe use, and many young patients are being deprived of potentially effective treatments for their conditions.

The US Food and Drug Administration (FDA) began an aggressive approach to improving pediatric prescribing information in 1997 by allowing drug companies to retain their patents (and therefore the profits from their sale) on drugs for an additional six months, if they agreed to study their pediatric use and safety. By 1999, the law had evolved such that the FDA could require manufacturers to investigate the pediatric usage of a medication if its availability to U.S. children would help at least 50,000 young patients and if it would provide a benefit over existing therapies for the condition.

In 2002, another law established a means to disseminate information about pediatric drug testing and this function was expanded in 2007 when the posting of all information about pediatric drug testing whether or not the drug was ultimately approved or marketed became required.

Reported, But Not Read?

But who really reads all this information and has it made a difference in the safe and effective use of medications for children? A recent report published in the December issue of the Archives of Pediatrics and Adolescent Medicine looked at whether the results of pediatric drug studies actually made it off the FDA website and onto the radar screens of providers who were writing prescriptions. They looked at the drugs which had been investigated and approved for use in children between 1997 and 2007 to see what types of problems had actually arisen during pediatric trials. Knowing that health care providers rarely review the original FDA data, they were particularly interested in the ways in which clinically important information that had appeared during drug trials was included, emphasized, or deemphasized in peer−reviewed journals, the most commonly read literature by health care providers.

...[O]f the 33 problematic products, only 16 were reported in the peer−reviewed professional literature... Seven [that were reported] did not accurately reflect the drug risks.

Over the study period, there were 137 products that were tested specifically for use in children. Of these, twelve had very concerning effects on behavior and mood, including becoming agitated and having thoughts of committing suicide. Twenty−one others showed a variety of safety issues including life−threatening spasm of the breathing passages or accelerated progression of cancer. The researchers felt that the frequency of dangerous side effect, when drugs that were considered safe for adults were given to children, was troubling.

Equally concerning was the finding that of the 33 problematic products, only 16 were reported in the peer−reviewed professional literature. Furthermore, while nine of the articles accurately reflected the FDA clinical trial review, seven represented and interpreted the original FDA data in a way that did not accurately reflect the drug risks.

The investigators found it troubling that FDA data about testing of drugs for safety and effectiveness in the pediatric population is not more widely published in the professional literature, and they felt that the number of concerning complications revealed by a review of the last ten years supports the critical need for increased attention to this topic. They proposed a required public submission of the same data that is given to the FDA hoping that this will improve professional access and utilization of the information.

What Parents Can Do

This study also provides some take-homes for parents:

  • Parents should immediately report any unusual behaviors or side effects that occur when using a medication, to the child's physician.
  • The decision to use medications is not taken lightly, and physicians use a risk/benefit assessment, weighing the known risks of the medication against the risk of failure to treat the child's condition. Parents should feel free to question their children's doctors about their medication choices and should be mindful not to give medication prescribed for another family member, particularly an adult, to their child.
  • Parents should always consult the drug label information, the pharmacist, or their physician for appropriate dosing of over the counter medication.
  • When doing research on the web, parents should be aware of the potential for information overload, and if they read something concerning about a medication, they should discuss it with the prescribing physician rather than simply discontinuing the treatment.

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