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 a number of 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 – even in children.
Janssen Pharmaceuticals and its parent company, Johnson & Johnson are facing hundreds of lawsuits related to Risperdal’s gynecomastia development and have been subject to multiple fines and penalties levied by governmental agencies due to improper marketing of the medication.
Johnson & Johnson is the world’s largest manufacturer of pharmaceuticals and medical products with estimated yearly revenue of $71 billion. Risperdal alone has brought in about $40 billion since its approval in 1993. The Risperdal franchise, including a sister-drug, Invega (paloperidone) continues bring in over $3 billion annually, despite the generic availability of risperidone.
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 rejected in 1996 due to lack of evidence and a lack of clarity as to what the medication would be used for.
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 reportedly 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. These incidences span back as far as 1994, long before any use in children or other disorders received FDA approval.
As early as 2001, reports had begun to surface regarding the 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.
Treatment of Gynecomastia from Risperdal
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.
Symptoms of Risperdal Gynecomastia
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
Risperdal Gynenomastia Reports and Studies
The first links to the development of gynecomastia related to Risperdal were reported in juvenile boys in the foster care system in Florida where Risperdal was being used in an “off-label” medication as a chemical restraint. In the same year (1999) results from a study of Risperdal use in conjunction with Prozac were reported that showed a link to gynecomastia. A 2006 study published in the Journal of Clinical Psychopharmacology showed evidence of elevated prolactin levels in adolescents who took Risperdal and another medical journal reported in 2009 that elevated prolactin levels could persist for two years following discontinuation of Risperdal.
Janssen and the parent company Johnson & Johnson have faced criminal and civil fines and penalties for improperly marketing Risperdal for use in children prior to the approval date and for marketing the medication for unapproved uses. The company also faces hundreds of lawsuits regarding the development of gynecomastia claiming that risks of Risperdal were downplayed.
Risperdal Gynecomastia Lawsuits
The first lawsuit regarding Risperdal related gynecomastia was filed in 2012 by a 21 year-old male who had received Risperdal from 1999 to 2004, beginning when he was only 9 years old, long before Risperdal use was approved in children.
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.