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Janssen Pharmaceuticals and its parent company, Johnson & Johnson, recently entered into a settlement agreement with the Commonwealth of Kentucky over allegations surrounding the drug Risperdal.  Janssen agreed to:

  • Pay $15.5 million to the state of Kentucky
  • Fully disclose the associated risks of Risperdal to consumers
  • Cease the company’s promotion of Risperdal for non-FDA approved uses

The lawsuit, filed in 2013, made allegations that Janssen had misled doctors and patients about the adverse side effects of Risperdal, deliberately concealing the fact that the drug was especially dangerous for children and elderly patients. According to court documents, Janssen allegedly marketed Risperdal to children before the U.S. Food and Drug Administration (FDA) gave the company its approval to do so, and also failed to disclose to parents and medical professionals that the medication could cause several serious conditions, including:

  • Gynecomastia (abnormal breast growth) in boys
  • Infertility in girls
  • A higher risk of death among elderly patients

What is Risperdal?

Risperdal is an anti-psychotic drug that was first approved by the U.S. Food and Drug Administration in 1993 to treat adults with schizophrenia. The FDA later approved additional uses for Risperdal, including treatment for:

  • Bipolar disorder in adults and juveniles
  • Schizophrenia in children
  • Certain behavioral symptoms in children with autism

How Does Risperdal Work?

Risperdal works by blocking the activity of dopamine in certain areas of the brain. But blocking dopamine also has an effect on the pituitary gland by causing a number of metabolic disruptions that result in the release of a hormone known as prolactin.

Prolactin is responsible for stimulating breast tissue development and causing lactation in pregnant and nursing women, and for causing gynecomastia in adolescent males and in children as young as four.

Gynecomastia can occur in one or both breasts and will not usually resolve on its own, even if Risperdal use is discontinued. In mild cases, liposuction may be used to remove the tissue, but in more extensive cases, breast reduction surgery or a mastectomy may be indicated.

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