Risperdal Lawsuits Filed Over Breast Growth Among Boys
Published: January 11th, 2010 • Comments: 2
At least 10 families have filed lawsuits against the makers of Risperdal and Invega, alleging that the antipsychotic medications, often used to treat attention deficit disorder and autism, caused teen boys to grow breasts measuring as large as a 38D cup size in some cases.
The lawsuits were filed recently in the Philadelphia Court of Common Pleas by the families of boys who took the medications and experienced the noticeable breast growth side effects. The Invega and Risperdal lawsuits accuse the manufacturers of negligence and fraud, and say they failed to adequately warn users about the potential male breast growth effects of the drugs when given to teen boys. Most of the lawsuits involve the use of Risperdal alone.
Risperdal (risperidone) and Invega (paliperidone) are manufactured by Janssen, a division of Ortho-McNeil-Janssen, a subsidiary of Johnson and Johnson. Risperdal is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism. Invega is approved for the treatment of schizophrenia.
The complaints allege that the boys experienced dramatic breast growth that was in addition to significant weight gain side effects of Risperdal and Invega. The boys’ doctors initially missed or dismissed signs of breast growth, assuming it was connected to the increases in weight. In some cases, the boys grew breasts as large as 38D, and the complaints indicate that some of the youths will require surgery for breast removal.
The lawsuits come as reviewers in the FDA’s Division of Pharmacovigilance (DPV) are calling for more in-depth investigation of the metabolic side effects of antipsychotics on children.
In a report issued in early December, FDA reviewers warned that adverse events reporting system relied on by the FDA to alert the agency about potential problems manifesting in approved products is not exacting enough to accurately detect and quantify potential problems with the antipsychotics. Reviewers pointed to a study released in October in the children on Zyprexa and Seroquel showed signs of rapid and dramatic weight gain and said that more studies need to be conducted into the metabolic effects of those and similar drugs.
Risperdal carries a warning that unusual breast growth could be a side effect of the medication, however the lawsuits say that the risks were not properly emphasized and that manufacturers downplayed the severity and numbers involved. According to prescribing information packaged with the drug, 2.3% of adolescents in clinical trials experienced breast growth due to elevated levels of the hormone prolactin.
Comment by Anne B on 14 January 2010:
Kids with autistic spectrum disorders often end up on antipsychotics because they are first put on stimulants for focus — and the stimulants make them violent.
The better thing is to try to accept that different people are different — not put them in chemical straight jackets.
Especially, recent obsession with raising kids’ achievement levels is forcing some kids into educational environments that are developmentally inappropriate for them. Less pressure should be put on elementary school children, especially boys, and they should be allowed more play and creativity time.
Kids with disabilities should not be expected to perform at the same level as kids without disabilities. That is insane.
Comment by SarahM on 21 March 2010:
In response to the first comment – no, we should not put our children in “chemical straight jackets” however, MANY children with ASD often engage in self injury or hurting others. Risperdal is supposed to help suppress that impulse. No one wants to wants to change their child; we would LOVE it if everyone accepted them the way they are, but they do not and many people are beyond cruel; heartless even. I have been investigating the recommendation to try this medication for my son, and I have to say, I am not comfortable with what I have read. However, I am tired of people throwing stones at the parents of children with ASD. If you have not walked in our shoes, do not throw stones or accusations. We only want what is best for our children; not to make them like everyone else. My son is the oldest of 4, he has much younger brothers I have to worry about, plus I have to worry about him hurting himself or worse! My child has never been on any type of medication and for most parents, medication is the VERY last resort.
Most schools are becoming very accommodating to children with ASD… if only the other kids would, and if only the children affected themselves would love themselves as much as we parents love them!