Antipsychotic Invega Tied to Male and Lactating Breasts. The antipsychotic medication, Invega (paliperidone), has been associated with mounting, serious injury reports, including a condition known as gynecomastia (male breasts). Invega is manufactured and distributed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
Invega is in the class of drugs known as atypical antipsychotics and is Invega is approved for the treatment of schizophrenia in adults and adolescents who are 12-17 years of age and for the short-term treatment of schizoaffective disorder as a monotherapy and as “an adjunct to mood stabilizers and/or antidepressant therapy in adults,” according to the Invega website. Invega and other antipsychotics work by restoring the brain’s chemical balance. The drug was first approved by the U.S. Food and Drug Administration (FDA) in 2006; however, Invega is also used off-label for the treatment of attention deficit disorder (ADD), Tourette syndrome, and disruptive behavior disorder, among other conditions. Invega has been associated with a variety of severe side effects in children. Of note, it is illegal for any drug maker to market a drug for uses not approved by the FDA-or off-label uses-although physicians are free to prescribe drugs for off-label purposes as they see fit.
Invega and other similar atypical antipsychotics are widely prescribed and Invega has been linked with various severe and long-term risks about which Janssen may not have appropriately warned patients and the healthcare community. Specifically, Invega has been associated with gynecomastia and teens taking Invega tend to be at a greater risk than adults taking the drug to develop male breasts. Invega has also been associated with hyperprolactinemia, which is the excessive production of the hormone prolactin and which may cause galactorrhea (the development of breast milk) and gynecomastia in males.
When young men develop enlarged breasts and lactating breasts, the disorders may cause severe shame and trauma, especially given how challenging puberty can be. Sadly, bullying and teasing may also contribute to the issues associated with gynecomastia and galactorrhea and may lead to significant emotional and psychological damage, including social devastation, in males affected by the conditions.
Gynecomastia does not involve the growth of excess fat in the breast area but is, rather, a buildup of excessive breast tissue that is similar to what occurs in growing female breasts. When males develop excess glandular tissue, the growths tend to originate as a small lump under the nipple, which may become tender and grow larger. Though the cause of gynecomastia is not fully clear, most physicians agree that the condition is the result of a hormonal imbalance.
Invega is classified as prolactin-raising antipsychotic because of its dopamine-blocking action, which may significantly increase prolactin levels. Prolactin is a hormone released by the pituitary gland. In girls, prolactin stimulates breast development and, in pregnant women, prolactin stimulates breast milk production. When increased levels of prolactin are present in males, the excessive levels may lead to similar processes known as gynecomastia and galactorrhea (abnormal lactation).
Mild to moderate gynecomastia cases may resolve when Invega is discontinued. Also, switching to a safer, prolactin-sparing antipsychotic medication is another option. Sadly, however, drug-induced breast enlargement may become persistent, especially in severe breast enlargement cases. It is when the gynecomastia does become persistent-for at least one year-that physicians typically suggest surgery.
Hundreds of boys and young men who have taken Invega have reported developing gynecomastia and, in some cases, the symptoms are only slightly noticeable; however, in many cases, breast tissue growth may be significant. In fact, in very serious cases, gynecomastia has been associated with size D male breasts. Often, men and boys must undergo liposuction treatment, breast reduction, or mastectomy to remove the excess breast tissue. All of the procedures are painful and leave scars; however, mastectomy is a serious and costly surgery. Some side effects of any of these procedures include significant scarring, blood clots, infection, anesthesia reactions, breast shape irregularities, and nerve damage.
In the same way that the degree of breast enlargement may vary, gynecomastia may occur differently with most males experiencing male breasts in both breasts; however, in some cases the condition affects just one breast. Also when gynecomastia occurs in both breasts, each breast may be can be affected differently with one breast growing larger than the other, adding to the patient’s discomfort and embarrassment. And, in some cases, the male breast, or breasts, may produce milk.
Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in drug injury claims. The firm continues to offer free, no-obligation legal consultations for individuals who seek to learn more about their rights concerning Invega gynecomastia, galactorrhoea, and hyperprolactinemia.
A 2013 study led by Dr. Brian I. Labow at Boston Children’s Hospital involved researchers administering a series of psychological tests to 47 boys diagnosed with gynecomastia who were an average age of 16.5 and compared the results with a group of boys with no breast enlargement.
The gynecomastia group scored lower for general health, social functioning, self-esteem, mental health, and eating behaviors. The negative effects were similar in males with varied levels of breast enlargement. This suggests that having the condition, regardless of severity, causes psychological damage in boys diagnosed with gynecomastia.
Invega Lawsuits on the Rise
Invega lawsuits brought against Janssen Pharmaceuticals and Johnson & Johnson are mounting and similarly allege that the drug makers neglected to adequately warn the public and the medical community about Invega’s serious risks, including gynecomastia, galactorrhoea, and hyperprolactinemia. Other serious side effects associated with Invega include diabetes, movement disorders, and nipple pain. In some cases, lawsuits have ended with plaintiffs being awarded millions of dollars in settlement money.
In November 2013, Johnson & Johnson agreed to a $2.2 billion Invega settlement to settle both criminal and civil fines with the Department of Justice (DOJ) over allegations that the drug maker improperly marketed Invega to children who then developed severe side effects such as gynecomastia and Type 2 diabetes.