The makers of antipsychotic drugs Risperdal and Invega are facing a series of lawsuits after boys taking the drugs grew breasts as large as ‘D’ cups.

The patients who were prescribed the antipsychotics for conditions ranging from attention deficit disorder to Tourette syndrome and disruptive behavior, experienced quick weight gain and breast growth to the tune of a size 38D, in some cases, the lawsuits say.

Because of the weight gain, the boys’ lawyer says their doctors may have overlooked the seriousness of the breast growth. Now many of the boys will require surgical breast removal.

The lawsuits accuse the manufacturers of Risperdal and Invega of negligence and fraud and say that the companies did too little to make people aware of the drugs’ potential side effects.

Risperdal is approved by the Food and Drug Administration to treat autism in addition to schizophrenia and bipolar disorder. Invega, a similar drug, is approved for the treatment of schizophrenia…
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Risperdal is also indicated in rapid weight gain and the development of diabetes. For more detailed information, see A Word of Caution About the Use of Risperidone.

However, a potentially permanent condition called Tardive Dyskinesia (TD) is listed as one side-effect of Risperdal use, and the study, featured on the New England Journal of Medicine, conducted was of too short a duration to measure instances of TD in the children.   “The short period of this trial limits inferences about adverse effects such as tardive dyskinesia.” (2)

TD is a serious, sometimes permanent side effect reported with RISPERDAL and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body.  Additionally, The Miami Herald reported in July of 2005 that several boys in Florida developed lactating breasts after taking Risperdal. (3)

Additionally Janssen, the manufacturer of Risperdal recently admitted that it “misled” health care professionals by downplaying the potentially fatal side effects of the drug including strokes, diabetes, and other potentially fatal complications in 2004. (4)

The Cochrane Collaboration, international not-for-profit and independent organization, dedicated to making up-to-date, accurate information about the effects of healthcare readily available worldwide, concluded  that “Risperidone can be beneficial in some features of autism. However there are limited data available from studies with small sample sizes. In addition, there lacks a single standardised outcome measure allowing adequate comparison of studies, and long-term followup is also lacking. Further research is necessary to determine the efficacy of risperidone in clinical practice.” (5)

AutismUAE cautions parents against the advice of physicians who would prescribe Risperdal for their children, especially if the children are under the age of those covered in the study (5) or do not present any of the symptoms of violence, aggression, or self-injury that Risperdal claims to be beneficial for.  Parents are strongly cautioned against the use of anti-psychotics or anti-depressant medications for children with Autism, and recommend seeking second or third opinions before making a decision about treatment.

(1) Official Risperdal Autism site

(2) The New England Journal of Medicine

(3)(4)  The Washington Post

(5) The Cochrane Database of Systematic Reviews 2009 Issue 3, Copyright © 2009 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).