Is Risperidone Worth A Billion Dollars

Recently, federal prosecutors have rejected a $1 billion dollar settlement with Johnson & Johnson over its off-label promotion of Risperidone. I guess J&J is not having a good year. Risperidone (Risperdal) is an antipsychotic drug used to treat schizophrenia, bipolar disorder and irritability in people with autism. Risperidone has been highly used in young adults (ages 13-17) since the only other alternative is lithium.

If we look at the FDA timeline, Risperidone was approved for schizophrenia in 1993, mixed and manic states associated with bipolar disorder in 2003 and for irritability in people with autism in 2006. This drug was a blockbuster for J&J averaging $2 billion in sales before a generic was available.

Risperidone Side Effects

Risperidone has side effects such as insomnia, high and low blood pressure (depends on the individual), stuffy nose, constipation, muscle stiffness and pain, Dysphoria (feeling of intense depression or disconnect), lactating breasts in men and sexual dysfunction. It is also known to increase weight gain and other metabolic disorders in patients. One of the worst side effects is photosensitivity to sunlight in the form of rashes, dry skin and even hair loss.

There has been a lot of controversy regarding elderly patients and Dementia. Dementia is the brain’s loss of cognitive function such as memory and problem solving. Studies have shown an increase risk of strokes and death while using Risperidone. The side effects resulted in 16 confirmed deaths of using Risperidone.

What Other Off-label Uses Are There?

Risperidone was promoted for off-label uses to treat anxiety disorders, obsessive compulsive disorders, severe treatment resistant depression (since all else failed), tourette syndrome and eating disorders to name a few. These uses were not FDA approved but they were at the discretion of doctors. J&J promoted these other uses since the disorders above usually have some similar characteristics.

J&J was caught with their hand in the cookie jar. They downplayed the risks associated with Risperidone in terms of stroke events and incidents of diabetes. In both cases, additional clinical trials proved their information to be false and misleading. J&J also delayed the reporting of new information to doctors by six months. I think this might have something to do with sales. Hence, we get the attempt at a billion dollar settlement after the fact. Now the billion dollar question is: At what point, does drug sales supersede human life?