UPDATE: 2013 Invega Settlement Awarded for $2.2 Billion

November 4, 2013 — Johnson & Johnson (J&J) will pay $2.2 billion to settle criminal and civil fines with the Department of Justice (DOJ) that they improperly marketed Invega to children who developed severe side effects, including gynecomastia and type-2 diabetes. Click here to read more.

Invega and Breast Growth

Invega (paliperidone) is an atypical antipsychotic medication that treats schizophrenia, but may also be used off-label for other psychiatric disorders. It was developed by Janssen Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) on December 20, 2006.

Unfortunately, Invega can have serious side effects, particularly in children. It can increase production of a hormone called prolactin (a condition called hyperprolactinemia), which stimulates the growth of breast tissue and milk production. In females, this can cause glactorrhea (production of milk). In males, this can cause gynecomastia (enlargement of male breast tissue).

What is the difference between Invega and Risperdal?

Ridperdal (risperidone) and Invega are both antipsychotic drugs with similar chemical structures and similar side effects — including gynecomastia. Invega is the major active metabolite of Risperdal.

What is a metabolite? When a person takes Risperdal, enzymes in the liver chemically change the drug components into metabolites, which are the active chemical substances in a drug. Individuals who take Invega instead of Risperdal eliminate one step in metabolizing the drug. However, the effect of a metabolite is essentially the same as the original drug.

What is Gynecomastia?

Gynecomastia is the enlargement of a man’s breast tissue due to a hormonal imbalance. It is different from fat deposits caused by obesity because it occurs in glandular tissue. Although the tissue is not cancerous or life-threatening, the condition can be very embarrassing for a young man and cause permanent psychosocial harm. The breast tissue may also be very sensitive, tender, painful, or uncomfortable.

Gynecomastia may require surgical treatment:

  • Liposuction: This procedure reduces the size of the breasts by removing fat deposits. It is only effective for mild or moderate cases.
  • Breast reduction surgery
  • Mastectomy: Removal of breast tissue and excess skin of the breast.

Invega Breast Growth Lawsuits

If you or your loved one suffered breast growth after taking Invega, you may still have time to file a lawsuit. In September 2012, Janssen Pharmaceuticals and Johnson & Johnson faced more than 130 lawsuits involving gynecomastia associated with Risperdal and/or Invega.

Many of the lawsuits were filed on behalf of young men who were prescribed the powerful antipsychotic medications to treat disruptive behavior disorders, Tourette syndrome, Attention Deficit Hyperactivity Disorder (ADHD), and more. One of the plaintiffs suffered rapid weight gain and growth of 38D sized breasts, and many plaintiffs required surgical removal of breast tissue.

The lawsuits allege that Janssen was negligent in failing to warn about the potential risk of breast growth..

Invega Side Effects

The most commonly reported side effects of Invega were restlessness, movement disorders, rapid heart beat, and sleepiness.

Other serious Invega side effects include:

  • Gynecomastia
  • Breast growth
  • Galactorrhea (milk production from breasts)
  • Diabetes, high blood sugar (hyperglycemia)
  • Bone loss (demineralization)
  • Sexual dysfunction
  • Pituitary tumors
  • Tardive dyskinesia (involuntary movement disorder)
  • Cerebrovascular events
  • Stroke
  • Transient ischemic attack
  • Heart rhythm disorder
  • Metabolic changes
  • Weight gain (may be extreme)
  • Increased risk of death for elderly patients with dementia
  • Seizures
  • Suicide


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