Month: May 2009

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CBS News “Poo Poos” FDA-Approved Autism Intervention

By Alison Singer

Reporter Sharyl Attkisson has had some outrageous pieces on the CBS Evening News, but her story Sunday night about risperdal has to be the most desperate.  Apparently ridiculing the life-saving value of vaccines is not enough, and she has now moved on to poo poo the only drug FDA approved for children with autism, because, tragically, a handful of children experienced a well known, but highly unfortunate side effect; increased level of the hormone prolactin.  For Ms. Attkisson, any product that comes out of a pharmaceutical company is just inherently bad, no matter how well tested or efficacious, no matter how many lives it saves, enhances or improves.

Let’s be clear about one thing; risperdal is FDA approved to treat symptoms of aggression, self injury, tantrums and mood changes in children and adolescents (age 5-16 years) with autism.  Thus, when Attkisson says use in autism is “off label” she is not correct.  In addition, ongoing studies of risperdal in the population of kids with autism continue to indicate efficacy, including several studies presented at the International Meeting for Autism Research (IMFAR) held earlier this month.

My daughter has taken risperdal for years and it has been truly life changing for her. Prior to starting risperdal, she had multiple violent tantrums each day during which she would thrash on the floor and bang her head and body. We would try to hold her and calm her, but the only way these episodes would eventually end would be that she would fall asleep from exhaustion. Risperdal significantly reduced both the frequency and intensity of her outbursts. For the first time, she was able to participate in learning activities, including ABA therapy, from which she has made (and continues to make) tremendous cognitive and behavioral improvement. With risperdal, she can attend to what’s happening in school, and she can participate in age-appropriate activities, like assisting in the middle school store. Risperdal does not cure autism, but it can enable children to be physically and emotionally available to participate in therapy and other activities from which they can achieve long term benefit.

Fortunately my daughter has not experienced any side effects. Many parents recount that they see tremendous benefit from risperdal, but have to discontinue use because of the challenging side effects. Increased weight gain is perhaps the best known side effect, but increased prolactin level is also a widely known side effect, despite Ms. Attkisson’s apparent shock at “discovering” this on the package insert. In fact, Janssen’s website for risperdal includes the following statement listed under Important Safety Information for Risperdal: “RISPERDAL and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.”  

Every doctor I have ever taken my daughter to, upon hearing she is on risperdal, has asked if we do regular liver function and prolactin level screenings. It is sad and disappointing that the families in Ms. Attkisson’s story did not learn of this from their doctor. Of course it is tragic when any child experiences negative side effects from an intervention intended to help him. It is even more tragic that the prescribing physicians in these cases either failed to fully understand risperdal’s side effect profile, or failed to adequately explain it to the children’s parents.  But this does not negate the tremendous value of FDA-approved risperdal to many individuals every day.

Alison Singer is co-founder and President of the Autism Science Foundation. She has both a daughter and an older brother with autism.

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