Excessive Prolactin Levels May Cause Gynecomastia

Janssen Pharmaceuticals Inc. and its parent company Johnson & Johnson have already been slapped with a $1.2 billion fine for downplaying the risks associated with the drug Risperdal.

Risperdal is an anti-psychotic drug originally approved by the FDA for psychotic disorders such as schizophrenia and bipolar mania. However, the drug was aggressively marketed for “off-label” conditions such as:

• Autism (even absent irritability)
• ADHD
• OCD
• Oppositional-Defiant Disorder
• Conduct Disorder
• Disruptive Behavior Disorder
• Tourette’s Syndrome
• PTSD
• Pervasive Developmental Disorder

In 2008, the Wall Street Journal Health Blog wrote about Risperdal’s “Troubling Side Effects in Boys,” warning that the drug could cause “the growth of breasts in some male patients.” Since then, the FDA has been petitioned to immediately revoke the pediatric indication for Risperdal until the long-term safety of the drug can be demonstrated.

Following the initial introduction of the drug, the warning label has been amended to include risk of “hyperprolactinemia” (excessive prolactin levels) which may result in “galactorrhea” (lactating), amenorrhea, gynecomastia and impotence. The drug’s manufacturer has been accused of erroneously claiming the levels of prolactin will fluctuate within the first couple of months in boys but then return to a normal range in 3-5 months. They have also been accused of underreporting the frequency with which young boys suffered from gynecomastia as a result of the drug.

For young males who took the drug Risperdal, side effects may include the following:

  • Male breast growth, or gynecomastia, which can become a chronic condition requiring surgical repair
  • Elevated female hormone levels and impaired sexual maturation
  • Severe weight gain, which in some cases may be inaccurately cited as the cause of abnormal breast growth

If you or a loved one has suffered side effects after taking Risperdal, please contact us today for a free, no-obligation consultation about your potential case.

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