Gynecomastia & Risperdal

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Risperdal (risperidone) originated in the early 1990s as a means of treating people who were suffering from varying forms of behavioral problems, including bipolar disorders and schizophrenia. The drug was developed by Janssen-Cilag, a subsidiary medical company of Johnson & Johnson, although today it is sold under different generic names after their patent expired in 2003. While this drug was successfully helping patients illnesses, many male patients were found to suffer from varying clinical consequences as a result of the prescription.

Doctors were discovering that patients using Risperdal were showing signs of gynecomastia and galactorrhea, from what they believed to be excessive exposure to the prolactin hormone used in the drug.

Defining Gynecomastia

Gynecomastia is defined as the abnormal growth of breasts in a male, which is excess tissue growth rather than fat. This benign breast enlargement is a non-cancerous growth, though it can cause severe discomfort for a male, along with varying degrees of psychological distress and body image concerns. This condition is often associated with galactorrhea, which is the milky white discharge that comes from the male's breast, similar to that of a female. Unfortunately, patients who have been diagnosed with this condition will likely have to deal with the abnormal tissue growth regularly, as it may continue to regrow even after surgical treatments in severe cases.

Studies show that if a patient waits longer than a year to treat it, the more difficult the removal process will become.

To remove the glandular breast tissues, the patient will have to undergo a surgical procedure that may include liposuction-assisted mastectomy, subcutaneous mastectomy, laser-assisted liposuction, or a laser-lipolysis procedure that does not use liposuction. As with any medical procedure, there are risks for complications.

With this particular process, the patient may be at risk of:

• Male breast asymmetry
• Hematoma
• Infections around the surgical wound
• Noticeable and sometimes painful scarring
• Changes in the sensation around the areas of the breast

Causes of Gynecomastia

Gynecomastia occurs when there are drastic changes in a man's testosterone levels.

Various factors can cause testosterone levels to decrease, such as:

• Natural hormone changes
• Medications
• Illegal drugs
• Alcohol
• Health conditions
• Herbal products

Multiple medications are linked to the development of gynecomastia. Anti-androgens, which are used to treat prostate enlargement, prostate cancer, and many other conditions, can cause gynecomastia, as well as anti-anxiety medications, tricyclic antidepressants, and antibiotics.

Symptoms of Gynecomastia

Gynecomastia is caused by a hormonal imbalance of estrogen and testosterone and can affect one or both breasts, often disproportionately. A study shows that gynecomastia in teenage boys can have negative effects on their self-esteem, as well as cause various other emotional health problems. In addition to the devastating psychological consequences of the condition, men and boys suffering from gynecomastia may also have pain in their breasts. Sometimes, gynecomastia resolves on its own, but the condition often requires medical or surgical intervention to return the patient to his former physique. Symptoms of gynecomastia include swollen breast tissue, breast tenderness, and nipple discharge.

Many medications can cause gynecomastia. These include:

• Anti-psychotic medications (ex. Risperdal & Invega)
• Anti-androgens such as Proscar and Aldactone
• Anabolic steroids and androgens
• AIDS medications like Sustiva
• Anti-anxiety medications like Valium
• Tricyclic antidepressants
• Antibiotics
• Ulcer medications
• Chemotherapy
• Heart medications (ex. calcium channel blockers)

Studies Connecting Male Breast Growth & Risperdal

In 1996, Psychopharmacology published a study called "Galactorrhea and Gynecomastia in a Hypothyroid Male Being Treated With Risperidone" that identified the growing concern between the usage of Risperdal and the growth of male breast. This study was done just a few years after Risperdal was approved to go out on the market by the FDA. Within this study, they found that in only twelve days on the Risperdal prescription, a 38-year-old male developed male breast and began producing a milky white discharge. The primary connection the researchers made was that due to this drug, the patient's prolactin hormone levels nearly doubled the normal range for males.

When the patient's prolactin levels were tested on day 13, doctors found him to be at 48.2 ng/mL, while the average range is between 1.4ng/mL to 242.2 ng/mL for a male. On day 14, the doctors pulled him off of the drug to monitor whether the Risperdal was the culprit of the increased hormone levels; in just 10 days, his numbers dropped into the average range at 9.6 ng/mL. Unfortunately, it took the patient a number of days before his breast ceased producing the discharge, and by day 87, his breast size had decreased 75%.

In 2006, the same journal published another study; here, they addressed the same concerns for gynecomastia found in adolescents. This study was conducted a year before Johnson & Johnson received official FDA approval to market the drug for the use of adolescents between the ages of 10 and 17 years old. Their research included the monitoring of 10 adolescent patients suffering psychotic tendencies; even though they were given relatively low dosages of Risperdal, three males developed gynecomastia, and two females showed signs of galactorrhea. From this study, doctors concluded that there are clinical consequences for adolescents taking any form of risperidone.

The doctors also warned of possible long term side effects, although there is still not enough research at this time to prove the connection. These possible long-term side effects may include:

• Osteopenia
• Infertility
• Growth and pubertal delay

2012 Johnson & Johnson Settlements

In September 2012, Johnson & Johnson faced six separate lawsuits relating to Risperdal and came to a settlement in all six of them. All six of the trials resulted in confidential settlements—which many contribute to the subpoenas that would have required the CEO of Johnson & Johnson to testify, as well as a former FDA Commissioner. One settlement came right before a case claiming Risperdal caused the plaintiff's gynecomastia was about to start the trial. The plaintiff's lawyer stated the results were anything but mild with the plaintiff's breasts growing as large as "D" cups. Unfortunately, his plaintiff was just one of many who suffered from this benign growth of male tissue, a condition many are claiming was downplayed by the manufacturer.

Gynecomastia & Risperdal FAQ

Talk to the Attorneys from Arnold & Itkin LLP About Your Case: (888) 493-1629

Our firm recently secured a massive, record-setting verdict of $76.6 million against Johnson & Johnson for injuries our client sustained from taking Risperdal. We were among the first lawyers to ever try a Risperdal case regarding gynecomastia, and our award was 20 times larger than the previous 4 Risperdal verdicts combined. Hundreds of lawsuits have been pursued against Johnson & Johnson for product liability, failure to warn, and other personal injury claims. While some cases have been settled, there are still many victims who have not come forward to pursue legal action against the company liable for their suffering or for that of their male child.

If you or a loved one is currently suffering as a result of the Risperdal drug, do not wait another moment before contacting a lawyer from the legal team at Arnold & Itkin. Our firm is committed to helping clients pursue justice and to fight for the compensation they deserve after wrongful injuries caused by negligent pharmaceutical companies. Our lawyers have recovered billions of dollars in verdicts and settlements for clients who have been wrongfully injured or have lost the life of a loved one. At our firm, we are confident in our ability to help you.

Don't be a victim any longer. Contact Arnold & Itkin and find out how we can fight for the future you deserve.