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If you were prescribed Invega as a child and developed breast growth (gynecomastia) or other side effects, you may be able to file a lawsuit. Drug-maker Johnson & Johnson (J&J) has already paid billions of dollars to settle state and federal lawsuits for illegally marketing Invega “off-label” for children.

What is Invega?

Invega Sustenna (paliperidone) is an atypical anti-psychotic drug manufactured by Janssen Pharmaceuticals (now a subsidiary of Johnson & Johnson). It is primarily used to treat schizophrenia and schizoaffective disorder in adults. It was approved by the U.S. Food and Drug Administration (FDA) in December 2006.

Invega vs. Risperdal

Invega is the primary active metabolite of Risperdal (risperidone), an older antipsychotic manufactured by Janssen. The two drugs treat psychiatric disorders in much the same way, although Invega is an oral extended-release version of Risperdal. Both drugs have similar side effects, including gynecomastia (male breast growth).

Invega and Gynecomastia

One of the most serious side effects of Invega is gynecomastia, which is caused by high levels of the hormone prolactin. In females, prolactin stimulates breast growth and milk production during pregnancy. In men, prolactin stimulates enlargement of glandular male breast tissue and other symptoms of gynecomastia.

Although the breast tissue is benign (non-cancerous), it can be physically disfiguring and psychologically traumatic — especially for young boys, who are likely to feel self-conscious about their appearance. Most doctors recommend surgery, such as a mastectomy or liposuction, to treat gynecomastia before it causes permanent psychosocial harm.

$2.2 Billion Invega Lawsuit Settlement with Justice Department

In November 2013, Janssen and J&J agreed to pay a $2.2 billion settlement with the U.S. Department of Justice for using illegal tactics to market Invega, Risperdal, and Natrecor. According to prosecutors:

“Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.”

As part of the settlement, J&J and Janssen will pay a total of $1.39 billion to resolve allegations of “off-label” marketing and paying kickbacks to doctors who prescribed Invega.

Invega Side Effects

  • Gynecomastia (male breast growth)
  • Tardive dyskinesia
  • Type-2 diabetes
  • Medically serious weight gain
  • Neuroleptic Malignant Syndrome (NMS)
  • Restlessness
  • Involuntary movement disorders
  • Rapid heartbeat (QT interval prolongation)
  • Sleepiness
  • Stroke and death in elderly dementia patients
  • Cognitive and motor impairment
  • Seizures
  • And more
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