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FDA Warns Not to Feed SimplyThick to Premature Infants

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At this time it is not known what about SimplyThick is making babies sick. FDA is actively investigating the link between SimplyThick and these illnesses and deaths.

In the meantime, adds Klontz, parents should stop using the product even if their babies don’t appear to be sick. “Why take the risk?” he asks.

Symptoms to Watch for

  • bloated stomach
  • greenish-tinged vomiting
  • bloody stools

Advice for Parents and Caregivers

  • Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.
  • Contact your health care professional if your baby has any of the symptoms listed above or if you have other concerns related to using SimplyThick.
  • You or your health care professional may report side effects related to using SimplyThick to FDA's MedWatch Safety Information and Adverse Event Reporting Program by:

What FDA Is Doing

FDA is actively investigating the link between SimplyThick and the illnesses and deaths. FDA will provide updates as information is made available.

For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).   

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