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Invega Gynecomastia Lawsuit


Invega (paliperidone) is an antipsychotic medication that can cause excessive breast growth (gynecomastia) in children. Although Invega gynecomastia is not life-threatening, swollen glandular breast tissue can be very painful, embarrassing, and socially debilitating. Surgery may also be necessary to reduce the size of the breasts.

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.

What is Invega used for?

Invega (paliperidone) is a medication that is used to treat severe psychiatric disorders like schizophrenia. It is also frequently used off-label to treat disorders like attention deficit disorder, Tourette syndrome, disruptive behavior disorder, and more. Invega belongs to a class of drugs called atypical antipsychotics, it was developed by Janssen Pharmaceuticals, and the U.S. Food and Drug Administration (FDA) approved Invega in December 2006.

Invega and Breast Growth

Invega is not approved for pediatric use in children under 18 years old and it has been linked to many severe side effects in children. One side effect is hyperprolactinemia, or excessive production of a hormone called prolactin, which causes the body to enlarge the breasts and produce milk. This can cause glactorrhea (milk production) in females and gynecomastia (breast growth) in males.

What is the difference between Invega and Risperdal?

Invega is very similar to Risperdal (risperidone), which is another antipsychotic medication that has been linked to gynecomastia. Invega is a metabolite of Risperdal. When a patient takes a dose of Risperdal, the liver breaks down the drug into its active chemical ingredients, which are called metabolites. Invega is the most important metabolite of Risperdal. It has essentially the same physiological effect as Risperdal, but it is metabolized differently.

What is Gynecomastia?

Gynecomastia occurs when a hormone causes swelling of glandular breast tissue in a male. It can affect one or both breasts, and it may also cause discharge from the nipples. The condition is not the same as fat deposits caused by obesity, because gynecomastia occurs in glandular breast tissue and is caused by hormones (such as prolactin). The swollen tissue is benign (non-cancerous), but it can be painful and tender. Because gynecomastia occurs during adolescence, it can also cause extreme embarrassment and lasting psych-social trauma.

Surgeries to cure gynecomastia include:

  • Liposuction: This procedure removes fatty deposits, and may be an option for treating mild or moderate breast enlargement.
  • Breast reduction surgery
  • Mastectomy: Surgery to remove glandular breast tissue and excess skin from the enlarged breast(s).

Invega Breast Growth Lawsuits

Individuals who developed gynecomastia or enlarged breasts after using Invega may still have time to file a lawsuit. As of September 2012, more than 130 lawsuits were filed against Janssen Pharmaceuticals and Johnson & Johnson alleging that the companies did not adequately warn about the risk of gynecomastia from Risperdal and/or Invega. Many plaintiffs have had surgery or will require surgery in the future. One plaintiff suffered from extreme weight gain and developed size 38D breasts while using Risperdal.

Settlement Reached in First Gynecomastia Breast Growth Lawsuit

Johnson & Johnson agreed to an undisclosed settlement in the first Risperdal gynecomastia lawsuit. The settlement was reached in September 2012 on the first day of trial. He took Risperdal when he was between the ages of nine and 13 years old (1999 until 2004), although Risperdal was never approved for children. He subsequently developed gynecomastia and required surgery to remove excessive tissue.

Invega Side Effects

The most common Invega side effects include rapid heart beat, restlessness, sleepiness, and movement disorders.

Invega has been associated with the following serious side effects:

  • 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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