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FDA Investigating Off-Label Tramadol Use in Children

Stephanie Samedi1 year ago

The US Food and Drug Administration (FDA) is investigating a risk for slowed or difficult breathing among children who were treated with tramadol.

About the Tramadol Investigation

Although tramadol is not approved for use in children, it is often given to the pediatric population in an “off label” form. According to Medscape, this can be dangerous because certain individuals can metabolize the drug more quickly resulting in difficulty breathing or even death.

The FDA is completing a review on the drug and will offer a conclusion and recommendations to the public.

Items Being Observed by the FDA

  • A 5-year-old boy in France experienced severely difficult breathing after taking a dose of tramadol.
  • Ultra-rapid metabolizers are at high risk for these types of side effects.
  • There are other pain medicines approved by the FDA for children that do not have the side effects of tramadol.


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