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.
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.
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.
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 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
- Ulcer medications
- Heart medications like Lanoxin and calcium channel blockers
Studies Connecting Male Breast Growth & Risperdal
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; 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 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
These possible long-term side effects may include:
- 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
lawsuits 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 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
that many are claiming was downplayed by the manufacturer with risks that
were not announced enough.
Hiring a Pharmaceutical Litigation 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 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 our office today for the attorney you deserve fighting for you!