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Elidel and Protopic Drug Warning

Pediatric Drug Warnings


Updated January 26, 2009

Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus) are two popular prescription medications that are used to treat children with eczema.

Unfortunately, many parents have become wary of using them because of recent concerns about their safety. New warnings and label changes from the FDA should now make it more clear about when Elidel and Protopic can be safely used.

First of all, remember that Elidel and Protopic should both be used only as second line treatments. This means that your child's eczema should be treated with other medications first, which will usually mean a prescription strength steroid cream. If that first line treatment doesn't work, then either Elidel or Protopic might be a good second line treatment option. But when using Protopic in children, only the Protopic Ointment 0.03% strength should be used. the stronger 0.1% ointment is only approved for adults and children 16 years and older.

And keep in mind that Elidel and Protopic should only be used if your child is at least 2 years of age. Remember that these medications are not recommended for children under 2 years of age.

Also remember that both Elidel and Protopic are only supposed to be used for short periods of time. They should not be used continuously for long periods of time.

FDA Boxed Warning

The latest warning about both Elidel and Protopic is that there is a 'possible cancer risk for these drugs.' However, keep in mind that reports of cancer have been 'rare' and are based on 'animal studies' and 'case reports in a small number of patients.'

So that doesn't mean that your Pediatrician can't prescribe Elidel or Protopic or that you shouldn't use them on your child. Just follow the safety guidelines mentioned above, try other treatments first, don't overuse the medicines, and don't use them for long periods of time.

In fact, the American Academy of Dermatology has issued a statement in response to the FDA warning, saying that they disagree with the FDA and that they believe that current research doesn't prove that Elidel and Protopic are dangerous when used properly.

The doctors at The National Jewish Medical and Research Center have also reviewed the data available to the FDA and think that 'the data does not show any definite association and is speculative' concerning the risk of cancer and infections. They continue to believe that both Elidel and Protopic are safe medicines and they will continue to use them. This includes continuing to prescribe them to children under age 2 'when appropriate.'


Elidel Medication Guide. Novartis. January 2006.

FDA News. FDA Approves Updated Labeling with Boxed Warning and Medication Guide for Two Eczema Drugs, Elidel and Protopic.

Protopic Medication Guide. Astellas Pharma US, Inc. January 2006.

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