The Risperdal/Gynecomastia Saga, a Summary
As a practice specializing in male breast reduction surgery, we have followed the media buzz about Risperdal, gynecomastia and the ensuing legal feeding frenzy. While our main concern is the well-being of our adolescent and adult patients with man boobs, it has been very interesting to see the saga unfold. Here’s a quick summary.
According to a variety of online legal news sites, Johnson & Johnson, the pharmaceutical giant, was granted FDA approval to market Risperdal in 1993. The drug was approved as an antipsychotic for adults with schizophrenia. In 2006, Risperdal was approved for use by patients with mental disabilities and children.
But a U.S. Department of Justice press release states that Janssen Pharmaceuticals, a J&J subsidiary, aggressively marketed the drug for use in children and people with mental problems well before 2006. The DOJ’s complaint alleged that Janssen’s sales reps were instructed to:
…call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism.
Although Risperdal and gynecomastia had been linked as early as 1999, ironically it was in 2006-the same year the drug was approved for more widespread use-that the body of evidence began to grow. A study published that year in the Journal of Clinical Psychopharmacology showed:
…risperidone [Risperdal] administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia…
As reported by Bloomberg News, in 2004, federal prosecutors began looking into the marketing and sales practices of J&J. Leveraging insider “whistleblowers,” investigators concluded that the company marketed Risperdal for off-label use, meaning uses for which the drug was not FDA-approved, and paid kickbacks to pharmacists and doctors. The investigations culminated in J&J agreeing to pay more than $2.2 billion in criminal fines, settlements with the federal government and several states, and awards to whistleblowers late last year.
Dozens of claims, lawsuits and class action suits have also been filed against J&J in the past few years on behalf of adolescents and adults who have developed gynecomastia. Today, when people search the Internet for information on the drug, the first search results direct them to lawyers offering to evaluate their cases.
When patients come in to our plastic surgery offices in NYC to consult us about gynecomastia, we perform our own evaluation. We start with a thorough examination (as we do with every patient, no matter what his or her cosmetic concern may be). We are happy to discuss all aspects of each case in detail, including every possible contributing factor.
Whether our gynecomastia-Risperdal patients decide to pursue legal action is, of course, entirely up to them. While they decide what’s best, we are always pleased to let them know that we can banish the unwanted breast tissue forever. Surgery is the only solution for gynecomastia, and we have worked with more than 2,500 men and young men in our practice.
We recently operated on two teens who took Risperdal. It’s our pleasure to play a role in helping these and other gynecomastia patients move forward with the rest of their lives.