A former head of the U.S. Food and Drug Administration said Johnson & Johnson’s Janssen Pharmaceuticals unit manipulated data involving the potential safety risks associated with Risperdal treatment in children.

According to a report by Dr. David Kessler, former head of the FDA, Janssen Pharmaceuticals manipulated the findings of a 2003 study that analyzed the potential for Risperdal treatment in children to cause devastating physical injuries.

In the study, researchers concluded that there was no direct link between elevated prolactin levels caused by Risperdal use and breast growth in boys and young men, a condition known as gynecomastia.

Dr. Kessler claims that accurate information about the link between Risperdal and gynecomastia was left out of the 2003 study, published in the Journal of Clinical Psychiatry, when the research findings were edited by the Janssen employees who co-authored the study.

Revelations about the misleading Risperdal gynecomastia data came about as a result of the growing number of Risperdal lawsuits brought against Johnson & Johnson over male breast growth and other complications allegedly caused by the drug.

Roughly 1,300 Risperdal gynecomastia lawsuits are pending in Pennsylvania state court, all of which involve similar allegations that J&J failed to provide adequate warnings about the risks of Risperdal use among male children.

Risperdal Study Data Manipulated

In recent testimony provided by Dr. Kessler, who is also a pediatrician, the former FDA commissioner indicates that Janssen Pharmaceuticals manipulated more than 40 manuscripts and understated the risk of Risperdal side effects in young boys, claims echoed by Dr. Dennis Daneman, top pediatrician at SickKids hospital in Canada and co-author of the 2003 Risperdal study.

The testimony comes just a year after a class action lawsuit was filed against Janssen Pharmaceuticals over its alleged manipulation of Risperdal clinical trial data, accusing the company of downplaying Risperdal health risks and writing misleading media articles in support of the medication.

In response to these claims of manipulation, Daneman and another researcher involved in the original 2003 study are having the Risperdal side effect data reexamined by an independent biostatistician, after which they will either issue a retraction of the research or provide corrections based on the new findings.

Risperdal (risperidone) is FDA-approved to treat adults and children with schizophrenia, bipolar disorder and irritability with autism. It is also often prescribed off label for behavior problems including ADHD and ADD.

Medications are approved by the FDA for uses based on safety and efficacy data provided by drug companies. The FDA determined that drugs like Risperdal can be effective for treating adults and children, and the agency has also identified potential side effects based on these studies.

If you or a loved one has suffered serious Risperdal side effects, contact a knowledgeable product liability lawyer today for legal help.