Risperdal Gynecomastia Side Effects. Risperdal (risperidone), is an expensive and dangerous option among other drugs in its class and has been associated with various serious side effects, namely gynecomastia (male breasts). Risperdal is manufactured through Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson. The most recent lawsuit, which was scheduled to be the next bellwether trial in this litigation, ended in a settlement before ever reaching the jury.
Initial cases are known as so-called “bellwether trials” and enable involved parties to more clearly understand future cases and to predict how future cases will turn out.
This case was settled for an undisclosed amount and the male plaintiff in this case filed the complaint and alleged he took Risperdal when he was seven years of age for over one year to treat his Asperger’s syndrome, oppositional defiance disorder (ODD), and impulse control disorder. A few years after he was taken off Risperdal, he began taking a generic form of risperidone for approximately four years.
If you or someone you know has been diagnosed with gynecomastia after taking Risperdal, the attorneys at Parker Waichman LLP would like to hear from you. Parker Waichman LLP is an expert in drug injury lawsuits and offers free case evaluations for anyone who has questions about their legal rights.
Risperdal Gynecomastia Lawsuit
The plaintiff in this lawsuit alleges that his gynecomastia was allegedly due to his use of Risperdal. The trial in this case was scheduled for Monday, October 31. Prior to the start of the trial, the involved parties in the litigation settled for an undisclosed amount.
This case is the second in the mass tort organized in the Philadelphia Court of Commons to be settled on the eve of the trial date. The first case was settled in May 2015. That case was also settled for an undisclosed amount. Four prior Risperdal lawsuits that reached trial led to large jury awards. In the first case, held in February 2015, the plaintiff received a $2.5 million jury award.
The second large jury award-in November 2015-led to a $1.75 million jury award. In the third verdict, the plaintiff was awarded $500,000 in a December 2015 decision. The fourth award was for $70 million in July 2016. Johnson & Johnson and Janssen Pharmaceuticals maintain that the settlements are not admissions of liability.
Johnson & Johnson Manipulated Risperdal Data
In some Risperdal gynecomastia lawsuits, plaintiffs allege that Johnson & Johnson and Janssen Pharmaceuticals knew about the risk of gynecomastia associated with Risperdal, but failed to disclose these risks to patients, physicians, and the U.S. Food and Drug Administration (FDA).
In a recent lawsuit, FDA Commissioner David Kessler testified that Janssen and Johnson & Johnson manipulated clinical data presented to the federal regulators to minimize the appearance of gynecomastia risk associated with Risperdal.
The study data revealed that boys taking Risperdal showed an increase in prolactin levels. When boys begin puberty, around 10 years of age, they naturally undergo changes that lead to a normal increase in prolactin.
To dilute the data, the makers of Risperdal chose to exclude all boys over the age of 10 from their clinical trial from the children who developed gynecomastia. The companies also added 103 girls who were not diagnosed with gynecomastia to the total number of participants.
The actual number of trial participants who had developed gynecomastia was 22, yet the companies only reported five. The actual number of boys in the trial was 489, but the companies reported that 592 were involved in the study.
In fact, the actual rate of gynecomastia reported in the companies’ studies was 4.5 percent; however, because only certain populations were chosen, Janssen and Johnson & Johnson manipulated the data to reveal only an 0.8 percent rate of gynecomastia, while later research revealed a 5.5 percent rate of gynecomastia.
Risperdal Side Effects
Risperdal is an antipsychotic medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. Risperdal has also been widely used off-label-uses not approved by federal regulators-for the treatment of an array of disorders in children that include autism and behavior disorders. That off-label use has also been tied with a variety of potentially serious and devastating conditions, including gynecomastia.
One of the most disturbing of Risperdal’s side effects is gynecomastia, which is enlargement of breast tissue in males.
Gynecomastia may affect one or both breasts, and sometimes occurs in both breasts. Risperdal may not pose any serious health threats; however, experts including the Mayo Clinic, point out that gynecomastia may cause psychological or emotional trauma.
Boys and men diagnosed with gynecomastia may feel pain in their breasts or feel shamed about their appearance. Signs of gynecomastia include swollen breast gland tissue and breast tenderness. The Mayo Clinic has advised patients to visit a doctor if they experience breast swelling, pain, or tenderness.
Another distressing adverse reaction to gynecomastia requiring medical review is nipple discharge in one or both breasts. The condition is known as galactorrhea, or unexpected milk production.
Risperdal causes a release of prolactin from the pituitary gland. Prolactin is a hormone that is naturally produced by males and females. In females, prolactin stimulates breast development and lactation. Mounting research has found that children taking Risperdal test with excess blood prolactin levels.
At least one study found that excess prolactin levels in Risperdal users may continue for up to two years after patients have stopped taking the antipsychotic.
Some girls taking Risperdal may also begin to lactate before reaching puberty
Some girls taking Risperdal may also begin to lactate before reaching puberty. Meanwhile, boys and men diagnosed with gynecomastia are often faced with decisions regarding treatment of the disorder. Because Risperdal has been associated to breast growth, and even lactation, in boys under 18, and because the conditions are typically long-term, regardless of if the drug is ceased, boys with Risperdal-associated gynecomastia must usually undergo breast reduction surgery.
Surgery includes liposuction or mastectomy to correct the condition. In some Risperdal gynecomastia reports, Risperdal users allegedly developed breasts as large as D cups.
Mastectomy and liposuction are painful procedures, and the physical and psychological problems suffered by many Risperdal victims may be even more difficult, which is why many families have chosen to file lawsuits against Janssen and Johnson & Johnson. Liposuction is typically used in mild to moderate gynecomastia. In more severe cases, mastectomy-a painful, extensive surgery that involves removal of both excess breast tissue and fat-is called for.
Johnson & Johnson is facing over 1,500 Risperdal gynecomastia lawsuits in Pennsylvania. When Risperdal was approved in 1993, it was approved for use in adults who were diagnosed with schizophrenia. Allegedly, Johnson & Johnson sought to expand Risperdal’s indications to include children and elderly patients. The FDA denied these initial attempts.