Date: February 19th, 2005 6:31:14 p.m.

Baby 411 E-news ALERT: Elidel and Protopic FDA warning; NBC Today Show to air autism series

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BABY 411 NEWS UPDATE: February 2004
The free eNewsletter for the readers of BABY 411
http://www.Baby411.com
February 2005
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In this newsletter:

1. Elidel and Protopic warning from FDA
2. NBC Today Show to air autism series.


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1. Elidel and Protopic warning from FDA

Please see the press release from the Food and Drug Administration (FDA) regarding two popular non-steroid creams used to treat eczema. At the current time, the FDA is recommending that these products be used with caution, for children over the age of two years.

FDA ALERT [02/14/2005]: FDA is investigating postmarketing reports of lymphoma and skin cancer in children and adults treated with Elidel and Protopic, but the causal relationship has not been clearly established. We are continuing to analyze these reports to determine whether the occurrence of these adverse events affects the risk/benefit assessment of Elidel or Protopic therapy.

Elidel is not approved for use in pediatric patients less than 2 years of age. This information reflects FDA’s preliminary analysis of data concerning this drug. FDA is considering, but has not reached a final conclusion about this information. FDA intends to update this sheet when additional information or analyses become available.

To report any unexpected adverse or serious events associated with the use of Elidel or Protopic, please contact the FDA MedWatch program at 1-800-FDA-1088 or http://www.fda.gov/medwatch/report/hcp.htm


As of December 2004, the FDA received 10 cases of postmarketing reports linking Elidel with cancer related adverse events. Four cases occurred in children, 3 of these in children less than 6 years of age. The other 6 cases occurred in adults. The most serious outcome was one hospitalization in an adult. All other cases reported non-serious outcomes.


As of December 2004, the FDA received 19 cases of postmarketing reports linking Protopic with cancer related adverse events. Three cases occurred in children up to 16 years of age, and 16 cases occurred in adults. Two deaths in adults were reported related to complications of the cancers, and 8 hospitalizations were reported, including 2 in pediatric patients. The 19 postmarketing cases included 9 lymphomas, 10 cutaneous tumors, of which 7 occurred at the site of Protopic application, as well as cases of squamous cell carcinoma, cutaneous sarcoma, malignant melanoma and other tumor types.


Recommendations: Physicians with patients using Elidel or Protopic, or who are considering prescribing the drug, should consider the following:

• Elidel/Protopic is a second line agent to treat eczema (atopic dermatitis) in patients unresponsive to, or intolerant of, other first line agents.

• Elidel /Protopic is not approved for use in children less than 2 years old because of higher incidence of infections reported in clinical trials in children who were treated with Elidel compared to placebo, and because the long-term effect of Elidel/Protopic on the developing immune system in infants and children is not known.

• The long-term safety of Elidel/Protopic cream has not been established. Treatment with Elidel/Protopic cream should be discontinued after the signs and symptoms of atopic dermatitis have resolved. If no improvement occurs after 6 weeks of treatment, or exacerbation of atopic dermatitis (eczema) is observed, treatment should be stopped and other therapeutic options considered.


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2. Autism Series to Run on NBC's Today Show Next Week

From February 21-25, NBC's Today show will run a 10-part series on autism entitled, "Autism: The Hidden Epidemic?"

The series hopes to educate the public on the signs and causes of autism, how it is diagnosed, what educational programs exist, how it affects families, and how parents of autistic children can better advocate for their children. An interview with AAP President Dr. Carol Berkowitz is scheduled to air the first day of the series. Segments will run at approximately 8:08 am and 9:08 am (in each time zone) each day for the week.

In addition, the Centers for Disease Control and Prevention (CDC), in partnership with many organizations including the AAP, has launched an awareness campaign called "Learn the Signs. Act Early." to educate parents about childhood development, including early warning signs of autism and other developmental disorders.

Additional AAP resources on autism can be found at: http://www.aap.org/healthtopics/autism.cfm

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That’s the news from here!