Gynecomastia & Risperdal

Risperdal, an antipsychotic medication used to treat schizophrenia, bipolar disorder and autism-related behavioral disorders in children and adults. It has been linked to an increased risk of gynecomastia or breast growth in males, including some children as young as 4 years of age.

Quick Summary
Risperdal Use in Children

Risperdal (risperidone) is a medication approved to treat schizophrenia in adults and children, bipolar disorder in adults and adolescents and irritability associated with autism in pediatric patients. It is an atypical antipsychotic that was intended to reduce side effects that are common in older medication used to treat psychotic disorders.

Risperdal was approved in 1993 by the Food and Drug Administration (FDA) for the treatment of schizophrenia in adults but application for use in children was rejected until 2006 when the medication was approved for bipolar disorder in adults and adolescents, schizophrenia in children and autism-related behavioral symptoms.

Despite initial rejection for use in children, Johnson & Johnson was accused and paid fines for illegal marketing and for fraud concerning off-label promotion of medication for unapproved used, including in children and adolescents.

Risperdal and Gynecomastia

Gynecomastia or breast tissue development in males may be caused by Risperdal antipsychotic action. Risperdal works by blocking dopamine and has an affect on the pituitary gland which may stimulate the production of prolactin, a hormone used for production of breast tissue and lactation in pregnant or nursing women.

While gynecomastia is troublesome in adult males, it is particularly concerning in juveniles and children. Permanent physical changes of breast tissue development may also create emotional and psychological trauma.

In addition to gynecomastia development in males, premature breast tissue growth may occur in young girls and some Risperdal users, including males and non-childbearing females may begin lactating. Gynecomastia as a side effect of Risperdal use has occurred in children as young as age 4 years and in most cases, will require surgical removal of abnormal breast tissue.

Gynecomastia & Risperdal

Risperdal (risperidone) is a medication approved to treat schizophrenia in adults and children, bipolar disorder in adults and adolescents and irritability associated with autism in pediatric patients. It is an atypical antipsychotic that was intended to reduce side effects that are common in older medication used to treat psychotic disorders.

Despite this intention, Risperdal has been shown to cause side effects similar to those seen with other antipsychotics, some of which are severe or even life-threatening but has also proven to cause gynecomastia or breast tissue development in males, including children as young as age 4 years.

Janssen Pharmaceuticals and its parent company, Johnson & Johnson are facing hundreds of lawsuits related to Risperdal’s gynecomastia development and have paid $billions in fines and penalties levied by governmental agencies due to improper marketing of the medication.

Risperdal Use in Children

Risperdal was approved in 1993 by the Food and Drug Administration (FDA) for the treatment of schizophrenia in adults. Johnson & Johnson also applied for use in children, but this application was initially rejected.

In 2006 and 2007 additional uses for Risperdal were approved including the treatment of bipolar disorder in adults and juveniles, schizophrenia in children and certain behavioral symptoms in children with autism.

Despite initial rejection for use in pediatric patients, Janssen and its parent company, Johnson & Johnson were accused of illegally marketed the medication for use in children and for unapproved uses such as ADHD, pharmaceutical restraint, dementia in the elderly and other psychiatric conditions beginning as early as 1994.

In 2001, the Miami Herald reported concerns about the large-scale use of Risperdal as a pharmaceutical restraint in the Florida foster care system and reports had also begun to surface regarding the frequent occurrence of breast development in juvenile males and other issues in children.

Gynecomastia and Risperdal

Gynecomastia is defined as the abnormal development of breast tissue in males. While it is troublesome in adults, it is particularly disturbing in juveniles and children. In addition to the physical changes, children are also often subjected to significant emotional and psychological trauma due to gynecomastia.

Risperdal works as an antipsychotic by blocking the activity of dopamine in certain areas of the brain but blocking dopamine also has an effect on the pituitary gland. The pituitary gland is responsible for hormone production and regulation of many body systems. Risperdal’s dopamine blocking activity works to stimulate the pituitary gland causing a number of metabolic disruptions and also results in the release of a hormone known as prolactin.

Prolactin is responsible for stimulating breast tissue development and causing lactation in pregnant and nursing women. While these women have high levels of prolactin, the hormone is normally very low in males, pre-pubescent girls, and women who are not nursing or pregnant. Stimulation of the pituitary gland leading to high prolactin levels has caused premature breast development in girls, lactation in non-nursing women and pituitary tumors. It has also caused gynecomastia in males who are adolescents and even in children as young as 4 years of age.

Gynecomastia is generally a permanent change, resulting in the development of actual breast tissue, different from simple fat deposits. The breast tissue must often be removed through surgery as it does not go away, even when the drug is discontinued.

Gynecomastia can occur in one or both breasts and can occur in an uneven fashion. Once the breast tissue has developed, lactation may occur. Some boys taking Risperdal have developed gynecomastia and began lactating. Girls and non-pregnant or nursing females have also developed breast tissue prematurely and begun lactating due to Risperdal use.

Treatment of Gynecomastia from Risperdal

Gynecomastia caused by Risperdal may develop in one or both breasts. The breast development may also be uneven or lopsided. It does not generally pose significant health risks but may be extremely emotionally and psychologically damaging, particularly in children and adolescents. Many Risperdal patients with gynecomastia experience lasting social embarrassment and trauma that continues into adulthood.

Physical symptoms of Risperdal related gynecomastia include:

  • Pain and tenderness in the breast area
  • Swelling and enlargement of the nipples
  • Growth in the breast area
  • Discharge from the nipples

Gynecomastia caused by Risperdal will usually not go away even if the drug is discontinued. In mild cases where not much mammary tissue has developed, liposuction may be used to remove the tissue but in more extensive cases, a breast reduction or mastectomy surgery will be required. This may also require removal of skin in a chest reconstructive procedure.

In addition to the emotional trauma that is likely to result from the development of gynecomastia, the patient may be subjected to significant surgical pain and may require a lengthy period of healing.

Risperdal Gynecomastia Lawsuits

Janssen and parent company Johnson & Johnson, have paid $billions in criminal and civil fines and penalties for improperly marketing Risperdal for unapproved uses including uses in children. The company also faces more than 13,000 lawsuits regarding the development of gynecomastia

Janssen and Johnson & Johnson face hundreds of additional lawsuits filed by patients who have developed gynecomastia after taking Risperdal and have been subjected to surgery and emotional trauma.