Risperdal (Risperidone) is a drug used to treat several disorders. It was originally approved to treat schizophrenia and closely-related disorders. However, the U.S. Food and Drug Administration later cleared the drug to treat bipolar disorder as well as aggression and irritability associated with autism.

As an atypical antipsychotic drug, it belongs to the second generation of antipsychotic drugs. Unlike the first generations, atypical antipsychotics were initially believed to be gentler on the patient and fewer side effects.

For example, earlier-generation antipsychotics were associated with neuromuscular side effects which mimicked Parkinson’s disease. However, as second-generation drugs have been used more, it has become apparent that many have devastating side-effects of their own, some of which may rival earlier drugs in their severity.

Risperdal Side Effects

Risperdal has been linked to a variety of serious side effects. However, the most high-profile is the alleged link between Risperdal and gynecomastia.

Gynecomastia is the medical term for “man boobs.” It has been alleged that Risperdal can cause young males to develop female-like breasts. This alleged side effect can be potentially devastating for young men. Embarrassment, coupled with the fact that the core demographic using the drug includes the mentally ill, means that many men who have suffered from this side effect have been reluctant to come forward. However, there is increasingly more litigation starting over this alleged side effect.

Legal Troubles

In addition to legal action over gynecomastia, the Risperdal drug maker Johnson & Johnson has also faced accusations that they have illegally marketed the drug.

In the United States, drug manufacturers are legally obligated to test a drug to FDA specification for safety and efficacy before selling the drug. Additionally, FDA approval is only granted for a specific condition. Drug manufacturers must do separate clinical trials and submissions to the FDA for every separate condition the drug is marketed for.

Even within this framework, physicians may prescribe a drug for purposes other than those approved. “Off-the-label” usage can sometimes fill the gap between the formal approval of an existing drug for a new condition. However, it is forbidden for drug manufacturers to promote a drug for such purposes.

An investigation by federal regulators, and a number of Risperdal lawsuits, have focused on the allegation that Johnson & Johnson promoted the drug for off-label uses. For example, it is alleged that the drug maker promoted the drug as a treatment for dementia. This allegation is serious, as it was eventually discovered that the drug increased the risk of death in elderly dementia patients.