Risperdal is a commonly prescribed atypical antipsychotic drug, used in the treatment of schizophrenia and bipolar disorder. The U.S. Food & Drug Administration (FDA) approved the drug for use in adults in 1993 and then for children in 2007.
Lawsuits have been filed over the issue of side effects caused by the drug when used in children. Many of the suits allege that the drug caused boys to grow breasts. This is believed to have happened due to elevated levels of the hormone prolactin, which stimulates breast development in girls and milk production in pregnant women.
Risperdal has also been associated with diabetes. In 2004, the FDA issued a warning letter to Johnson & Johnson’s Janssen unit stating that it had failed to disclose that the drug carried a risk of hyperglycemia and diabetes mellitus. The FDA cautioned Janssen Pharmaceuticals, stating it:
“Omits material information about Risperdal, minimizes potentially fatal risks associated with the drug, and claims superior safety to other drugs in its class without adequate substantiation…”
At one trial, it was shown that Janssen knew of potential diabetes risks as early as 1999. The company had studies showing a possible link and failed to disclose them to the FDA.
According to Bloomberg News, one witness testified that “Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes, while claiming the antipsychotic drug didn’t cause the disease.”
One medical expert testified that as early as 1999 the Johnson & Johnson Janssen unit had one study that showed about half the patients taking Risperdal developed diabetes after a year on the medication. That study concluded that Risperdal caused patients to develop “medically serious weight gain” which led to the diabetes. During this same time period, Janssen salespeople were telling doctors that research showed Risperdal didn’t cause diabetes.
Risperdal now contains a warning of increased risk of diabetes in some patients with schizophrenia and that this risk is stronger with some antipsychotic drugs.
Patients who develop symptoms they believe are related to taking Risperdal need to be mindful of the statute of limitations for filing a lawsuit. The time limit varies from state to state. The statute of limitations typically starts from the date the person is diagnosed with the ailment or serious adverse reactions.
At one time, Risperdal was among Johnson & Johnson’s top-selling products. It generated $2.2 billion in sales before it lost its U.S. patent protection in 2007.