August 22, 2014 — Middle-aged men who use Risperdal (risperidone) face a 69% increased risk of gynecomastia (male breast growth) compared to men who do not take anti-psychotic drugs, according to a study published in the Journal of Clinical Psychopharmacology.
Conclusions were based on data from men between the ages of 40 and 85 who were newly diagnosed with gynecomastia between January 2001 through June 2011. They identified 8,385 cases of gynecomastia and each case was matched with 10 controls. Of the cases of gynecomastia, 27 occurred in men on Risperdal.
Researchers found that men on Risperdal were 69% more likely to be diagnosed with gynecomastia. Risperdal was also associated with a 40-41% higher risk of gynecomastia compared to other anti-psychotic drugs, including Zyprexa (olanzapine) or Seroquel (quetiapine).
The findings of the study are consistent with the number of reported cases to the U.S. Food and Drug Administration (FDA), with Risperdal having the highest number of reported cases. They also corroborate conclusions of a study in the Netherlands that also showed Risperdal had a higher rate of gynecomastia than Zyprexa or Seroquel.
Data from the study was presented in March but not published until this month.
In recent years, Johnson & Johnson has faced hundreds of lawsuits from men who were given Risperdal as children and developed gynecomastia. These lawsuit accuse the drug-maker of improperly marketing Risperdal in children and failing to warn about the risk of gynecomastia.
In addition to physical disfigurement (cup-sizes up to 38D have been reported), many plaintiffs allege they suffered long-term psychological symptoms. Others needed painful and expensive surgeries to remove abnormal breast tissues.
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