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According to a lawsuit, a 2003 study used by Janssen Pharmaceuticals said that Risperdal was not linked to increased levels of prolactin that causes the development of breasts in boys; however, an earlier study found that the drug was not safe for boys for that very reason. In 1993, alleges the lawsuit, the drug was approved for use in adults to treat schizophrenia. The research at that time did not support use of the drug in boys because of the risk of severe Risperdal side effects.
Janssen supported a study in 2003, however, that did not find evidence of a link between the growth of breast tissue in boys, known as gynecomastia, and Risperdal. The Food and Drug Administration approved it for use in 2006.
Now, say lawsuits filed by young men who experienced severe Risperdal side effects, data from Janssen’s own study show that there was evidence of a link. The lawsuits allege that the drug maker downplayed the evidence of severe Risperdal side effects in order to gain FDA approval of the drug that has netted the company billions.
According to a report in New Brunswick Today, Janssen’s own researchers admitted that tables showing a correlation between Risperdal and risk for development of gynecomastia were not provided to the FDA as a part of the approval process for the drug.
Further, according to the Risperdal lawsuits, the 2003 study was intended to reveal severe Risperdal side effects and original tables from the study show a statistical correlation between the drug and elevated prolactin levels. But, says the lawsuit, researchers reported to the FDA that there was no correlation.
A different team of researchers will reassess the original tables to determine whether Janssen misrepresented the 2003 study’s conclusions.
“Based on the findings, we will decide whether the paper warrants full retraction, a partial correction or whether the original findings stand,” one of the researchers told Spectrum News.
Other experts in child psychiatry expressed concern over the discovery of alleged research misconduct on behalf of Janssen. The experts note that the newly revealed severe Risperdal side effects further damages the reputation of the pharmaceutical industry.
“This is disheartening on many levels,” one expert who was not involved with the studies or the lawsuits told Spectrum News. “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.”
Severe Risperdal Side Effects
Risperdal has garnered billions of dollars for Janssen and other drug makers after it was approved for use in children for the treatment of autism and other disorders. However, young adults are now saying that they suffered severe Risperdal side effects that they, their doctors, and their parents were not warned about.
Alleged side effects include the development of breast tissue in boys, as well as weight gain, headaches, sleep problems, fatigue, restlessness, nausea, vomiting, and stomach pain.
If you or a loved one suffered severe Risperdal side effects, contact the attorneys at McDonald Worley to help evaluate your claim.