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Gynecomastia & Risperdal

Drug Injuries

Gynecomastia & Risperdal

Risperdal (risperidone) originated in the early 1990's as a means of treating people who were suffering with 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 is sold under different generic names after their patent expired in 2003. While this drug was successfully helping the patients illnesses, many male patients were found to suffer with 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 actually 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 galactorhea 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 the condition, the more difficult the removal process will become.

In order 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, as well as changes in the sensation around the areas of the male breast.

Symptoms of Gynecomastia

Gynecomastia is caused by a hormonal imbalance of estrogen and testosterone, and can affect one or both breasts, often disproportionately. In addition to the devastating emotional consequences of the condition, men and boys suffering with 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.

Signs and symptoms of gynecomastia include:

  • Swollen breast gland tissue
  • Breast tenderness

A number of medications can cause gynecomastia. These include:

  • Anti-psychotic medications such as Risperdal and 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 like Lanoxin and calcium channel blockers

Studies Connecting Male Breast Growth & Risperdal

In 1996, the medical journal 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 just 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 in order to monitor whether the Risperdal was in fact the culprit of the increased hormone levels, and 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%. Their entire study was over a period of 294 days.

In 2006, the same journal published another study titled "Risperidone-induced symptomatic hyperprolactinaemia in adolescents"; 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

Hiring a Pharmaceutical Injury Attorney in Houston

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 a number of victims who have not come forward to pursue legal action against the company liable for their own 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 Houston injury lawyer 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 injury lawyers have recovered over $1 billion 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, and will stop at nothing to see that your case is resolved in a favorable manner.

Don't be a victim any longer, contact our office today for the attorney you deserve fighting for you!

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