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FDA Cautions Doctors on Use of Drugs Elidel and Protopic for Eczema
WASHINGTON (AP) - The Food and Drug Administration issued an advisory to doctors Thursday urging caution in prescribing two drugs for eczema, because of the possibility of cancer.
The drugs Elidel and Protopic will receive new label warnings pointing out that an increased risk of cancer may be associated with their use, the agency said. Elidel and Protopic are applied to the skin to control eczema by suppressing the immune system. But animal tests have shown an increase in cancer associated with the drugs and a small number of cancers have been reported in children and adults treated with the drugs, the FDA said in its advisory. The FDA said the manufacturers of the products have agreed to do further tests to determine the actual risk. The agency said it is developing a medication guide for patients. It urged physicians considering prescribing the drugs to consider the following:
-Elidel and Protopic are approved only for short-term and intermittent treatment of eczema in patients who don't respond to or cannot tolerate other treatments.
-These drugs are not approved for use in children younger than two-years-old because the long-term effect on the developing immune system is not known.
-These drugs should not be used continuously. The long-term safety of these products is unknown.
-Children and adults with a weakened or compromised immune system should not use Elidel or Protopic.
-Use the minimum amount needed to control symptoms. The animal data suggest that the risk of cancer increases with increased exposure.
Dr Sears Comment: Most pediatricians (myself included) have been using these creams for a few years thinking they were very safe – even using them under two years of age (only approved down to 2 years). They have been tremendously effective in treating eczema and other skin irritation without the typical side effects of the steroid creams such as thinning skin. Most experts still feel that the cream is safe and will continue to use Elidel and Protopic; however, they will probably do so more cautiously. In our office we will probably discontinue use in children under age 2 until more safety research is done.
Chicken Pox Deaths Decreasing
The U.S. Centers for Disease Control and Prevention (CDC) reports that at least eight people, adults and children, in the United States died from chickenpox in 2003 and 2004, even though a safe and effective vaccine against the disease is available. The CDC noted that three children--14 months of age, 10 years, and 12 years--who died of chickenpox during the two-year period had been healthy before contracting the disease but had not been vaccinated against chickenpox. "The findings in this report underscore the importance of timely routine vaccination of children aged 12 to 18 months and catch-up vaccination of older susceptible children and adolescents," the CDC said.
Dr Sears comment: Before the vaccine was widely used, about 50 people would die from chicken pox each year. Most of these were adults who contracted the illness from their unvaccinated children. This represents a decrease by over 90%. It is interesting to note that in recent years, chicken pox has been the number one killer of all the vaccine preventable illnesses IN AMERICA. It is nice to see this finally decreasing. In our office, I routinely give this vaccine at the 15-month check-up. If parents are reluctant to give it and want to wait until the child is older, I tell them that when their child turns 7 or 8, then I will really, really suggest it, because as the child gets older, the severity of this “routine illness” gets worse. I often also inquire if the parents have had chicken pox. If not, then I suggest getting a blood test to check for chicken pox immunity – and vaccination if the tests are negative.
Children Who Watch TV More Likely to Bully - Study
CHICAGO (Reuters) - The more television 4-year-old children watch the more likely they are to become bullies later on in school, a U.S. study said Monday. At the same time, children whose parents read to them, take them on outings and just generally pay attention to them are less likely to become bullies, said the report from the University of Washington. Previous research had indicated that emotional support from parents helps young children develop empathy, self-regulation and social skills, making them less likely to be bullies, said the report published in the April issue of the Archives of Pediatrics and Adolescent Medicine. The Washington study reached its conclusions by looking at data from a study of 1,266 four-year-olds whose bullying -- based on assessments from their mothers -- was tracked at ages 6 through 11. Overall, about 13 percent of the children turned out to be bullies. The study also took into account the stimulation the children received as measured by outings, reading, playing and what role the parents played in teaching the children.
Dr Sears Comment: First of all, I let my kids watch television. I am not “anti-TV”. What is important is WHAT they watch, and HOW they watch. I think there is a problem when kids are left unattended for hours, watching whatever they want. There are many “kid” shows that are not appropriate for all ages. I see this many times when there are older siblings involved. My kid’s friends that have an older brother tend to watch shows that I would never allow my kids to watch. They tend to be the violent cartoons that seem harmless, and maybe are fine for a sixth grader. But the show is just too violent for the younger sibling. I think a parent should try to watch along with their children for a few reasons: 1) supervision. 2) you get to spend more time with your kids, and 3) You will stay connected with their world. My first grader is always talking about the shows he is watching, telling me about which character did this or that, and it’s nice to be able to converse with him about all this.