Risperdal, Invega and Gynecomastia

Hundreds of lawsuits have been brought against Johnson & Johnson’s pharmaceutical unit, Janssen Pharmaceuticals Inc., over its antipsychotic drugs, Risperdal (risperidone) and Invega (paliperidone), and the drugs’ associations with gynecomastia, a condition known as male breasts.

Risperdal, Invega and Gynecomastia

Hundreds of lawsuits have been brought against Johnson & Johnson’s pharmaceutical unit, Janssen Pharmaceuticals Inc., over its antipsychotic drugs, Risperdal (risperidone) and Invega (paliperidone), and the drugs’ associations with gynecomastia, a condition known as male breasts.

Invega is a metabolite of Risperdal. When taking Risperdal, the patient’s liver breaks down the medication into its active chemical ingredients, which are known as metabolites. Invega is the most crucial of Risperdal’s metabolites and, while metabolizing differently than Risperdal, provides an essentially identical physiological effect.

Both Risperdal and Invega are in the drug class known as atypical antipsychotics and are approved for the treatment of schizophrenia. Risperdal may also be prescribed for the treatment of bipolar disorder and autism spectrum disorders. Risperdal and Invega have been prescribed off-label for the treatment of depression, attention deficit hyperactivity disorder (ADHD), sleep disorders, and anxiety disorders; Invega has been used off-label to treat attention deficit disorder (ADD), Tourette syndrome, and disruptive behavior disorder.

Gynecomastia is listed as a potential side effect of both Risperdal and Invega. The significantly adverse effects of Risperdal- and Invega-induced gynecomastia and galactorrhoea, as well as associated risks and financial loss associated with the often-required surgical treatments for these disorders, are the focus of hundreds of lawsuits.

Male Breast Growth (Gynecomastia) and Abnormal Lactation (Galactorrhoea)

Reports have included boys and young men developing unusually large breasts that resemble female breasts. This condition is known as gynecomastia. In some cases, the breasts may lactate (produce milk) following treatment with Risperdal and Invega. This condition is known as galactorrhoea. Other reports include, in part, depression, anxiety, social anxiety, and other psychological issues.

Young men and boys who develop gynecomastia are faced with serious potential surgical decisions, such as undergoing double mastectomy to have the breasts removed or liposuction, to reduce breast tissue.

How Risperdal and Invega may Lead to Gynecomastia and Galactorrhoea

Risperdal and Invega are classified as prolactin-raising antipsychotics. The dopamine-blocking property of these antipsychotics increases prolactin levels. Prolactin, a hormone released by the pituitary gland, stimulates breast development and breast milk production in women. When high levels of the hormone, prolactin, are found in males, similar processes to those seen in women, who naturally produce prolactin during breast development and when pregnant and nursing, may occur. In men, the abnormal development of breasts is a condition called gynecomastia and the condition of lactating breasts in men is called galactorrhea. In very serious cases, males have reported breast development as high as D cups.

When males take Risperdal or Invega, the drugs accumulate fat in their chest tissues, but may also cause them to develop excess glandular tissue. The growths generally start as a small lump beneath the nipple, and the nipple may become tender and increase in size. These reactions may occur in one or both nipples and may develop differently in the two breasts, with one breast growing larger than the other.

Risperdal-induced hyperprolactinemia, a condition involving increased prolactin levels, may occur in the majority—90 percent—of the population, according to an article published in The Journal of Clinical Psychiatry. This adverse reaction may continue throughout treatment and may continue even after discontinuation of the medication.

The Effects of Male Breast Growth and Male Breast Lactation

While typically not a serious health threat, gynecomastia may lead to significant and challenging emotional and psychological damage. In fact, a study conducted at Boston Children’s Hospital in 2013 revealed the potential damage associated with gynecomastia. The researchers, led by Dr. Brian I. Labow, administered various psychological tests to 47 boys diagnosed with gynecomastia who were an average age of 16.5. The test results from this group of boys was compared to a group of boys who were not diagnosed with gynecomastia.

The research indicated that the participants who were diagnosed with gynecomastia scored lower in the areas of general health, social functioning, self-esteem, mental health, and eating activities. These effects were similar in all subjects diagnosed with gynecomastia, regardless of the severity of the disorder. This finding suggests that simply having gynecomastia—regardless of if the gynecomastia was found to be mild, moderate, or severe– lead to psychological damage. Having male breasts is often uncomfortable to the point of being quite painful, very embarrassing, and socially incapacitating.

For those boys and men who required surgery to reduce their enlarged breasts, physical pain and trauma was also experienced. Complications of this surgery include reactions to anesthesia and other related medications, significant scarring, infection, blood clotting, nerve damage, and irregular breasts following surgery. Some of these reactions may be deadly.

The Symptoms of Risperdal Gynecomastia and Invega Gynecomastia

The key symptom of gynecomastia is male breast enlargement, which may or may not affect both breasts and may or may not lead to symmetrical reactions. Enlargement typically involves the glandular tissue and the nipples and causes a larger, tapering breast. In one case, a patient was diagnosed with gynecomastia that led to 38D-sized breasts.

Other symptoms include:

  • Breast pain, tenderness, sensitivity
  • Swelling nipples
  • Nipple discharge
  • Firm breast and nipples
  • Psychological and psychosocial trauma

Treating Gynecomastia

In cases in which gynecomastia is deemed mild to moderate, the condition may resolve when Risperdal or Invega treatment is ceased. While other antipsychotic medications that are prolactin sparing may be used in treatment, some cases become persistent and will necessitate surgical intervention, such as mastectomy or double mastectomy, male breast reduction, or standard or laser-assisted liposuction. This is typically seen in cases in which the gynecomastia has led to larger breast development. The disorder is considered persistent if the condition has remained for at least one year.

Increased Gynecomastia Risk Seen in Older Men

In March 2014, researchers presented data from a study that tied Risperdal use to a 69 percent increased risk of gynecomastia in older men with a median age of 65.5, suggesting that the condition associated with Risperdal and typically affecting boys and young men, may now include older men.

Researchers from the University of British Columbia analyzed data on more than 1 million United States men who filed health claims with the IMS LifeLink Health Plan from 2001-2011. Of those who filed, 8,285 cases of gynecomastia were seen during the study period.