Undisclosed Clinical Data Led To Thousands Of Pending Lawsuits Over Risperdal Side Effects

October 28, 2016 – – In July 2015, Janssen Pharmaceuticals was ordered to pay $70 million in damages after a boy developed breasts as a result of taking Risperdal, manufactured by Janssen, a daughter company of Johnson & Johnson (J&). To date, thousands of other lawsuits are still pending against the company. It now appears that the two pharmaceutical giants manipulated data provided to the FDA in order to hide the extent of the gynecomastia risk.

Risperdal was initially approved by the FDA in 1993. The pharmaceutical companies tried several times to expand its approved use, wanting it marketed to more patients. However, the FDA had concerns about side effects and declined these requests. The most serious side effect was that of increased levels of prolactin, which causes men to grown female breast tissue.

In response, the two pharmaceuticals studied how big the risk of gynecomastia actually was. They did find that the percentage of boys who would develop it was so high that the FDA would not approve it for children. It has been claimed, however, that this data was cleverly diluted. Boys hit puberty around age 10, at which point their prolactin levels rise normally. It is rare for this to lead to gynecomastia, however. Yet, the company excluded all boys older than 10 from their clinical trials results, but they did not remove them from the number of participants. Furthermore, they also added 103 girls to their participant list.

What this means is that of the 22 young boys who developed gynecomastia, only 5 were reported. 489 boys took part in the trial, but 592 were reported. This meant that the rate of gynecomastia was actually 4.5%, and not the 0.8% that the company reported. In later trials, it was found the actual rate of gynecomastia was 5.5%.

It has been claimed that when the data had been manipulated, it was presented to the FDA, who approved the drug to be used on children with autism in 2006. Less than a decade later, J&J pleaded guilty to illegally marketing the drug and misrepresenting its side effects, leading to a $2.2 billion fine paid to the Department of Justice. Thousands of lawsuits against the companies are still pending, monitored and supported by www.risperdal-settlement.com.

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