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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.