Invega (paliperidone) is an atypical antipsychotic medication approved by the U.S. Food & Drug Administration (FDA) in 2006 to be prescribed for the treatment of schizophrenia in adults and adolescents from 12 to 18 and in adults.

It is also prescribed in conjunction with other medications to treat some patients with depression. Invega has not been approved for use in children.

Side Effects of Invega

Manufactured by Johnson & Johnson’s Janssen Pharmaceuticals, the medication works by altering the effects of the chemicals in the brain. As with all medications, Invega has been associated with a number of side effects, including:

• Increased sensitivity to extreme temperatures
• Severe allergic reaction
• Numbness or tingling on one side of the body
• Weight gain
• Heart attack
• Onset of diabetes
• Suicide
• Movement disorders such as tardive dyskinesia

The active ingredient in Invega is a metabolite of Risperdal, another antipsychotic that is also marketed by Johnson & Johnson’s Janssen Pharmaceuticals unit. As such, Invega, which is an oral extended-release version of Risperdal, works in a similar manner to Risperdal, and carries many of the same risks, including gynecomastia (male breast growth).

Invega and Gynecomastia

Among the side effects of Invega, one of the most serious concerns is the development of breasts in young boys, known medically as gynecomastia, which is caused by high levels of the hormone prolactin

While not life-threatening, gynecomastia can be an extremely painful and embarrassing condition, causing a great deal of emotional and psychological damage in young boys and men who have been prescribed the drug to treat a pre-existing mental illness.

Symptoms of gynecomastia can include:

• Swelling of the breast tissue
• Pain or discomfort in the breast area
• Nipple discharge in one or both breasts

Gynecomastia-related breast tissue will not go away, even with weight loss or when a patient stops using Invega. Some gynecomastia victims have reportedly developed female-like breasts as large as a 44DD cup.

When the condition becomes this severe, patients may be forced to undergo costly and painful surgical procedures, including liposuction or mastectomy, to remove their excess breast tissue.

While not life-threatening, gynecomastia can be an extremely painful and embarrassing condition, causing a great deal of emotional and psychological damage in patients who have been prescribed the drug to treat a pre-existing mental illness.

Study Links Invega to Male Breast Growth

According to a recent study which was presented at the American Association for Geriatric Psychiatry (AAGP) 2014 annual meeting, use of Invega may result in the development of male breast tissue.

Researchers evaluated national health claims data in older men who used paliperidone (Invega) or risperidone (Risperdal). According to the data, these men were 69 percent more likely to develop gynecomastia than nonusers.

Filing an Invega Lawsuit

Invega has been associated with the development of gynecomastia in men ranging from adolescents, young adults, and older men as well. 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.

According to the DOJ:

“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.”

Invega patients who were diagnosed with gynecomastia may be entitled to compensation for medical bills, lost wages, emotional distress and more. To discuss filing your own Invega lawsuit, contact a product-liability lawyer as soon as possible.