Risperdal Causing Breast Development in Children as Young as Four

Risperdal, a prescription medication approved for use in children for several psychiatric disorders can cause breast development in boys. Some of the boys and young girls developing breasts due to this medication will also begin producing milk. This rarely publicized side effect was highlighted in a recent story on the CBS Evening News. (1)

Risperdal, manufactured by Janssen, is approved for use in adults and adolescents as young as age 10 for schizophrenia and bipolar disorder. It is also approved in children as young as age 5 for treatment of irritability caused by autism. It is only approved for psychotic behavior within these diagnoses but some physicians prescribe it to pediatric patients before the age of 5 and for disorders other than psychotic behavior associated with schizophrenia, bipolar disorder or autism including aspergers syndrome and ADD/ADHD which do not have true psychotic behavior.

Though not specifically mentioned in the general prescribing information as an "adverse event", Risperdal is known to cause gynecomastia or abnormal breast development and occasionally even lactation or milk production in boys and young girls and also in adult men.

Hyperprolactinemia, elevated levels of the hormone prolactin is listed as a side effect and is thought to be the cause of breast development. Prolactin is the hormone which stimulates milk production. Normally present in high amounts only in breast feeding women, an excessively high level can cause breast budding, breast growth and even milk production in any person including adult men, boys, and young girls.

In several different studies of Risperdal use for autism, schizophrenia, bipolar disorder and other psychiatric disorders, up to 87% of pediatric and adolescent patients aged 5-17 had elevated prolactin levels after only 8 weeks. In a study involving 1885 children, 43 reportedly developed abnormal breast tissue. In other studies involving children as many as 2.3% developed gynecomastia and 0.8% began producing milk.

Hyperprolactinemia may also be responsible for suppression of gonadotropin releasing hormone GnRH which would mean that all of the sex hormones would be suppressed. This may inhibit reproductive function and lead to a delay of appropriate pubertal development, particularly important for boys. Decreased levels of GnRH will lead to low testosterone levels and a significant delay of development of all male secondary sex characteristics such as facial and body hair growth, increased musculature, genital enlargement and voice deepening. (2)

According to CBS News, attorney Stephen Shiller represents 10 children who were given Risperdal and developed abnormal breast tissue, one of whom was only 4 and had to undergo a mastectomy after he began lactating. On behalf of the children, Shiller has filed suit against Janssen with claims that Janssen is marketing Risperdal for unapproved uses such as treatment of ADHD and that the labeling for Risperdal is not clear as to the threat of breast development in children. Janssen has denied such claims.

The only treatment for gynecomastia is unfortunately a radical mastectomy. Many of the children affected will have to undergo surgery and possibly counseling for psychological issues caused by the medication. (3)

sources.

(1) Sharyl Attkisson, CBS News, The New Drug Of Choice

(2) Janssen, risperdal.com, Risperdal Full U.S. Prescribing Information

(3) Sharyl Attkisson, CBS News, The New Drug Of Choice