In July 2016, Risperdal manufacturers Johnson & Johnson and Janssen Pharmaceuticals were asked to pay $70 million to a Tennessee man and his family.

More recently, Risperdal has been in the news because critics are now questioning the validity of the Risperdal clinical trials before its approval in 1993.

In the earlier lawsuit, a video deposition showed former Food and Drug Administration commissioner, David Kessler, testifying that both Johnson & Johnson and Janssen manipulated data in the Risperdal clinical trials to downplay the risks of gynecomastia while using the drug.

What are Risperdal Side Effects?

Risperdal is a drug that has been used since the early 1990s to treat several physiological and neurological problems.

Generally, Risperdal is prescribed for patients with schizophrenia, but it has also been used to treat bipolar disorder as well as certain types of autism.

Some forms of autism present symptoms as aggression and irritability. Risperdal has been known to help these symptoms without leaving a patient feeling “drugged.”

Given the success of this drug, Risperdal has also been associated with life-altering side effects.

Gynecomastia, more commonly known as “man boobs,” is a potential Risperdal side effect.

Risperdal has been known to increase the levels of prolactin in the body. Prolactin is responsible for breast growth in women and milk production in nursing mothers.

In young men or boys, increased prolactin levels can have a devastating effect. It can create a condition called gynecomastia, or the abnormal growth of breasts in males.

After Risperdal was approved in 1993, the drug manufacturers attempted to get Risperdal approved for more uses.

However, the FDA was wary of approving Risperdal for other conditions because they were concerned about the side effects.

Risperdal Clinical Trials

Johnson & Johnson and Janssen coordinated their own Risperdal clinical trials regarding the risk of gynecomastia. Their studies revealed too high a percentage of gynecomastia in boys for the FDA to approve Risperdal use in children.

The drug companies have now been accused of diluting the data found in the Risperdal clinical trials.

At the onset of puberty, usually around age 10 in boys, prolactin naturally occurs in the body.

But, Johnson & Johnson and Janssen opted to exclude all boys over the age of 10 in their Risperdal clinical trials from the number of children who developed gynecomastia.

They did not, however, exclude boys 10 and up with gynecomastia from the overall study. Allegedly, in the attempt of further muddying the data, they added 103 girls without the condition to their Risperdal clinical trials.

Allegedly, the actual number of participants in the Risperdal clinical trials who had gynecomastia was 22, but Johnson & Johnson and Janssen only noted five, as well as reporting 592 boys participating when in actuality it was 489.

Apparently, according to the true Riserpdal clinical trials data, the gynecomastia rate was 4.5%. The drug companies only reported 0.8%. Studies done later actually show the rate at closer to 5.5%.

Unfortunately, with this manipulated data, J&J and Janssen sought FDA approval for use of Risperdal in children for the treatment of autism.

In 2006 the approval was granted; however, more recently, the drug companies were ordered to pay $2.2 billion for civil and criminal charges that Risperdal was illegally marketed for use with children and that they misrepresented the risks of Risperdal.