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Pediatric Drug Warnings

Pediatric Basics

By , About.com Guide

Updated October 27, 2007

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Reports of drug warnings on medications such as Vioxx and Crestor aren't limited to adult medications. There have also been warnings, including the addition of 'black box warnings' on a number of drugs that are used to treat children. These include warnings on Elidel and Protopic, used to treat children with eczema, Adderall for ADHD, Phenergan, an anti-emetic, and all antidepressant drugs because of the increased risk of suicidal thinking and behavior.

Add the highly publicized lawsuits that claim a link between Motrin, Advil with Stevens Johnson Syndrome and you may not want to give your child any medications at all.

A better approach is to be aware of drug warnings, possible side effects, and risks, and weigh them against the drugs benefit to your child. If the benefit is worth the risk, as it is with most medicines, then you should feel comfortable to continue to treat your child under your Pediatrician's guidance.

It might also be a safe idea to not be quick to jump on the bandwagon and use the 'latest and greatest' drugs, when an older drug might work just as well. Your doctor should have much more experience using these older drugs and their side effects and risks are more likely to be well known.

And although many medicines are safely used 'off-label' for conditions or ages that they aren't FDA approved for, you should also discuss the risks and benefits of doing this and consider using FDA approved medications first. You might also make sure that your doctor has experience using these 'off-label' medicines or consider seeing a specialist with more experience.

Elidel and Protopic Warning

Warnings from the FDA about Elidel and Protopic, two medicines used to treat children with eczema, were added because of a potential cancer risk which was discovered in animal studies. There were also a small number of possible reports of cancer in children and adults who were treated with Elidel and Protopic.

When using these medicines, it is important to keep in mind this advice from the FDA:

  • Elidel and Protopic are not approved for use in children younger than 2 years old and using it should be avoided in these younger children.
  • Elidel and Protopic should be used only for short periods of time, not continuously.
  • Elidel and Protopic are approved for short-term and intermittent treatment of atopic dermatitis (eczema) in patients unresponsive to, or intolerant of other treatments, like steroid creams and ointments. So they are second-line agents and you should try other treatments first.
  • Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.
  • Use the minimum amount of Elidel and Protopic needed to control your child's symptoms. The animal data suggest that the risk of cancer increases with increased exposure to Elidel or Protopic.

Adderall XR Warning

Adderall and Adderall XR were also in the news because Health Canada temporarily suspended their sale after post-marketing reporting of sudden death in children and adults taking the medicines. The FDA however did not feel that the 'number of deaths reported is greater than the number of sudden deaths that would be expected to occur in this population without treatment' and Adderall XR is still a commonly prescribed stimulant for ADHD in the United States. A warning was added though, saying that patients with underlying heart defects should not take Adderall XR.

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