Gynecomastia in Risperdal Users
Gynecomastia is a condition characterized by abnormally large breasts in males. It is the result of excessive breast tissue growth, not excess fat. The condition is often caused by hormone imbalances in the body. In the case of Risperdal, the problems stem from an overabundance of the hormone prolactin.
In clinical trials involving 1,885 children and adolescents taking Risperdal (risperidone), 43 boys experienced gynecomastia. Since the U.S. Food and Drug Administration (FDA) approved Risperdal, hundreds of boys have developed breasts that resemble those of women’s while on the medication. In some cases, boys’ breasts grow as large as “DD” cups.
Johnson & Johnson manufactures and markets Risperdal. The FDA approved the drug for treatment of schizophrenia, bipolar disorder and autism spectrum disorders. Doctors also prescribe the drug for “off-label” treatment of attention deficit hyperactivity disorder (ADHD), sleep disorders, anxiety disorders and depression.
How Risperdal Causes Male Breast Growth
Prolactin controls sex drive in males. The pituitary gland produces prolactin, and the neurotransmitter dopamine controls the levels of the hormone. Risperdal blocks dopamine’s action on the pituitary gland and can cause the levels of prolactin to increase and reach abnormal levels — a condition known as hyperprolactinemia.
In women, prolactin stimulates breast development and breast milk production. When high levels of prolactin are present in males, those excessive levels can prompt similar processes, resulting in gynecomastia, sometimes accompanied by galactorrhea (abnormal lactation). In severe cases, males have developed large, D- and DD-cup sized breasts.
According to an article published in the Journal of Clinical Psychiatry, elevated prolactin levels may occur in more than 90 percent of Risperdal users at some point during treatment. This effect, referred to as Risperdal-induced hyperprolactinemia, often persists throughout Risperdal therapy and for some time after the drug is discontinued.
In children and adolescents, the overabundance of prolactin can cause:
- Milky, nipple discharge in both males and females (galactorrhea)
- Absence of periods in females
- Delay in growth
What Gynecomastia Looks Like
Males who take Risperdal not only accumulate fat in their chest tissues, as can happen in overweight boys and men, but they also develop excess breast tissue. Growths typically begin as a small lump under the nipple. The nipple may become tender and gradually will grow larger.
The degree of enlargement can vary from one individual to another, and while gynecomastia most often occurs in both breasts, it can affect just one. When the condition strikes both breasts, each can be affected differently. One breast can grow larger than the other, leaving the drug users with an even more uncomfortable social stigma. In some cases of gynecomastia, males produce breast milk.
Mild to moderate cases of gynecomastia may resolve themselves with discontinuing the use of Risperdal. Switching to a safer, prolactin-sparing antipsychotic medication becomes an option at that point.
If enlarged breasts remain for a year or more, doctors may suggest surgery to normalize breast size. Many men and boys have had to undergo standard or laser-assisted liposuction, male breast reduction surgery or mastectomy to resolve male breast enlargement.
Effects of Gynecomastia
Male breast growth is generally not a threat to physical health. However, it is a condition that often causes a great deal of emotional and psychological damage in males affected by it.
Complications can come with breast surgery, including:
- Prominent scarring
- Blood clots
- Anesthesia reactions
- Breast shape irregularities
- Nerve damage
In an April 2013 study headed by Dr. Brian I. Labow at Boston Children’s Hospital, researchers administered a series of psychological tests to 47 boys with gynecomastia and 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. These negative effects were similar in subjects with varied levels of breast enlargement, suggesting that merely having the condition, no matter if it is mild, moderate or severe, damages boys psychologically.
Additionally, men and boys who need surgery to resolve breast enlargement also suffer physical pain and trauma. These detrimental effects of Risperdal-induced gynecomastia and the risks and expense of surgical treatment of the condition have led to the filing of hundreds of lawsuits against the manufacturer of Risperdal.
Risperdal can cause muscular and neurological problems called extrapyramidal symptoms (EPS). These are uncontrolled movements that involve a series of short quick movements of the limbs, head and tongue, or slow, painful, twisting movements that are repeated over and over. People may even make involuntary noises such as grunting.
While most antipsychotic drugs come with a higher risk of these disorders, atypical antipsychotics like Risperdal cause even more cases of EPS.
People with these conditions often consider the movements embarrassing, tiring and disruptive. They also tend to feel isolated and may be embarrassed to go out in public. Sometimes the movements are so severe that they are disabling. For some, the conditions remain even after they stop taking the medication.
If a patient notices any loss of motion or control while taking these drugs, a doctor needs to address the problem before it becomes irreversible. Although addressing EPS often involves stopping treatment with antipsychotics, some patients may require continuation of Risperdal therapy despite the presence of movement disorders.
Why Some Risperdal Users Develop Movement Disorders
Researchers don’t understand why or how antipsychotic medications cause these disorders. Some theories point to the way antipsychotics alter the levels of neurotransmitters like serotonin and dopamine in the brain.
Dopamine is responsible for regulating body movement, and it is possible that by altering dopamine levels, Risperdal can cause unnatural and involuntary movements. This may cause abnormal stimulation of the parts of the brain that signal muscles to move. In many cases, patients will have irreversible damage to receptors in the brain.
Some of the most common movement disorders caused by Risperdal include:
Tardive means delayed and dyskinesia means abnormal movement. Tardive dyskinesia involves involuntary movements most often affecting the lower face. This disorder is characterized by quick, jerky, repetitive movements that are more embarrassing than painful.
The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the dose administered increase. There is no known treatment for established cases of tardive dyskinesia, although doctors may recommend discontinuing use of Risperdal in attempt to lessen or stop symptoms completely.
Symptoms of tardive dyskinesia include:
- Facial grimacing
- Finger movement
- Jaw swinging
- Repetitive chewing
- Tongue thrusting
Tardive dystonia is a form of tardive dyskinesia. It involves slower, painful, twisting movements of the muscles. Symptoms of dyskinesia and dystonia can be similar in the way they present themselves, and their symptoms may overlap.
Symptoms of tardive dystonia include:
- Difficulty speaking
- Difficulty breathing
- Difficulty swallowing
- Neck spasms (sometimes progressing to tightness of the throat)
- Uncontrollable blinking
In clinical trials, parkinsonism was listed as one of the most common adverse reactions to Risperdal. When caused by a medicine, it is also referred to as secondary parkinsonism. This helps differentiate the condition from Parkinson’s disease.
Like tardive dyskinesia and dystonia, parkinsonism causes involuntary body movements. Elderly users are most susceptible.
Symptoms of parkinsonism include:
- Decrease in facial expressions
- Loss or weakness of movement
- Soft voice
- Stiffness of torso, arms or legs
- Memory loss
- Difficulty controlling body movements
- Slow, shuffling gait
- Stooped posture
Heart Problems and Death
Numerous studies show Risperdal and other atypical antipsychotic drugs can interfere with the electrical impulses that regulate heart rhythm, causing cardiac arrhythmias that can lead to cardiac arrest and death.
Another rare but serious side effect is neuroleptic malignant syndrome (NMS), a life-threatening neurological condition that occurs in less than 1 percent of patients taking an antipsychotic medication.
In a 2009 study published in the New England Journal of Medicine, researchers found that users of atypical antipsychotic drugs had a rate of sudden cardiac death that was more than twice the rate for nonusers.
Risperdal carries a black-box warning about an increased risk of death in elderly patients with dementia-related psychosis who are treated with the drug. Risperdal is not approved for these patients.
Arrhythmia (Irregular Heartbeat)
All antipsychotic drugs, including Risperdal, are associated with increased risk of arrhythmia, or irregular heartbeat.
A 2002 study evaluated risk of arrhythmia and cardiac arrest in schizophrenic patients treated with risperidone (Risperdal), clozapine, thioridazine or haloperidol between 1993 and 1996. According to the study, patients using these drugs had rates of arrhythmia and cardiac arrest between 1.7 and 3.2 times higher than that of a control group (even though members of that control group were older than the patients taking antipsychotic drugs). Death rates also were higher — 2.6 and 5.8 times higher.
Of the four drugs evaluated, Risperdal had the highest risk of cardiac arrest, arrhythmia and death, and surprisingly, that risk increased with lower doses of the drug.
Other heart issues associated with Risperdal include metabolic changes that can increase the risk of disease, such as hyperglycemia, diabetes, dyslipidemia and weight gain.
Risperdal can cause the pituitary gland to grow in size. This disrupts the production of hormones and can lead to the development of pituitary tumors.
One study published in the journal Pharmacotherapy analyzed the FDA’s adverse effect database and found that Risperdal accounted for 70 percent of all pituitary tumors. The researchers also said that there may be more cases but the adverse events are underreported.
While pituitary tumors are usually benign, they can cause other serious health problems such as vision problems, internal bleeding, headaches and even convulsions.
Patients with schizophrenia are already at an increased risk of diabetes mellitus (type 2 diabetes) compared with the general population. On top of this, studies suggest a relationship between antipsychotic use and high blood sugar incidents, known as hyperglycemia-related events. Patients on any antipsychotic should monitor their glucose levels.
Risperdal is associated with elevated blood sugar levels and diagnoses of type 2 diabetes, including, in rare cases, extreme ketoacidosis (shortage of insulin) resulting in coma or death. Studies suggest that the risk of type 2 diabetes is higher with atypical antipsychotics than with traditional antipsychotics.
Weight gain is one of the most common side effects of Risperdal. In one study, Risperdal patients gained an average of 4.6 pounds after 10 weeks of treatment. The FDA reports that patients on Risperdal had “a statistically significantly greater incidence of weight gain.”
Weight gain is problematic for several reasons. Aside from the health risks of obesity, weight gain is a primary reason that patients stop taking their medication, which often results in a relapse of their condition. Weight gain can also lead to diabetes.
Other Side Effects
Risperdal has also been linked to the following side effects, according to the FDA:
- Akathisia (restlessness)
- Abdominal pain
- Priapism (prolonged penile erection)
- Somnolence (sleepiness)
Patients who experience any side effects while taking Risperdal should contact their doctors. They should not stop taking these drugs without consulting with a doctor, as this may result in withdrawal and a relapse of symptoms.
Emily Miller is an award-winning writer who has held editorial positions with reputable print and online publications around the U.S. As the editor of Drugwatch.com, Emily draws on her background as both a patient and a journalist to ensure her team of writers provides consumers with the latest and most accurate information on drugs, medical devices, procedures and related lawsuits. Emily holds five Health Literacy certificates from the Centers for Disease Control and Prevention as well as a Bachelor of Science in Journalism from the University of Florida. She is a member of The Alliance of Professional Health Advocates, the American Association for the Advancement of Science, the Society of Professional Journalists and the Society for Technical Communication.