A recent Risperdal lawsuit accuses Janssen Pharmaceuticals, the manufacturer of the antipsychotic drug, of omitting key data from its 2003 study on Risperdal side effects.

Risperdal (risperidone) is an antipsychotic drug that is used to treat schizophrenia and bipolar disorder and it was also approved to treat the symptoms of irritability in children with autism.

However, many patients and the medical community have reported serious Risperdal side effects, raising concern about the actual safety of Risperdal use for men and young boys.

Initially, Risperdal was not considered safe for use in children who had not yet reached puberty because it can boost prolactin levels.

Prolactin is a hormone that is found in males and females, but at a much higher concentration in females, as it is a hormone that stimulates breast growth and milk production.

Risperdal Side Effects Studies

A 2003 study in the Journal of Clinical Psychiatry, backed by Janssen, showed that there was no link between male breast growth and elevated prolactin levels. It found an initial rise in prolactin levels for one or two months, followed by a decline to normal prolactin levels.

Risperdal’s label does currently include a warning that male breast growth is one of several possible Risperdal side effects. Most physicians only prescribe Risperdal, or any drug for that matter, when the benefits outweigh the potential risks posed by the drug.

In 2013, Janssen reached a settlement in a lawsuit brought by the FDA for a total of $2.2 billion to settle accusations that the pharmaceutical company engaged in aggressive marketing of Risperdal in 2002 and 2003 for non-FDA approved uses.

One such target group of the aggressive marketing was children with autism.

Following the settlement with the FDA, a number of individual lawsuits against Janssen followed. One Risperdal side effects lawsuit included a male plaintiff, now 21 years-old, who received a $2.5 million settlement last year.

The plaintiff was diagnosed with autism and took Risperdal from 2002 to 2006, and allegedly suffered Risperdal side effects, including male breast growth.

Misconduct in Risperdal Side Effects Studies?

In this Risperdal lawsuit, there was evidence presented by the plaintiff that included an early manuscript of the 2003 study. In the manuscript, there were two data tables that were included that were subsequently removed from the final published version.

What appears to be missing from the 2003 study findings is the data in the tables that directly contradicts the finding that there were no “side effects hypothetically attributable to prolactin,” or SHAP.

These Risperdal side effects include male breast growth, but it was concluded in the study that “there was no direct correlation between elevated prolactin and SHAP.”

The tables allegedly show a statistical correlation between elevated prolactin side effects and male breast growth, as well as other Risperdal side effects.

A biochemist who worked for Janssen allegedly testified that the data and these tables were never provided to the FDA, according to an article in New Brunswick Today.

What many consumers don’t seem to realize is that when the FDA approves a drug, there is no external third-party investigation that is required to test the safety and efficacy of pharmaceuticals. The drug companies themselves are the ones allowed to test the drugs which many would agree shows a conflict of interest.

The FDA website states “It is the responsibility of the company seeking to market a drug to test it and submit evidence that it is safe and effective.”

The FDA’s role is to have its consulting scientists and physicians review the study data before approval.

Since there is no third-party oversight during the testing and study outcome submission, one might easily be able to conclude that a drug manufacturer omitting important data from a study does not appear to be a difficult thing to do.

In response to learning about the alleged data omission regarding Risperdal side effects, a University of Washington Professor of Psychiatry and Behavioral Sciences, Dr. Bryan King MD stated, “This is disheartening on many levels. Scientific misconduct is scientific misconduct. I honestly don’t see any difference between withholding something in a deliberate attempt to influence the findings and just making it up.”