Brockton, MAJose says he has been given Risperdal injections to treat bipolar disorder for about 10 years - ever since he has lived in the psychiatric ward of the VA hospital.
“The Risperdal did help with my bipolar condition but I started developing breasts and blurred vision,” says Jose.
The VA Boston Healthcare system offers a wide range of services to homeless veterans, including housing. But there is just so much they can do. Jose says he asked doctors to switch Risperdal to another medication when a relative alerted him to the association between gynecomastia - a hormonal imbalance that leads to breast growth in men and boys - and Risperdal. “I had to put up a fight to refuse the Risperdal injection, even though it clearly states on the billboard here that a patient can refuse a medication,” says Jose.
If not for Jose’s relative warning him of the antipsychotic drug’s side effects, he would still be taking Risperdal. “I had my eyesight tested but I don’t think glasses will help with this blurry vision” he says. “I’m hoping that my eyesight will get better now that I am taking another med but I quit Risperdal almost a year ago and nothing has changed, including these breasts I’ve grown.”
Meanwhile, the FDA has been asked to change the labeling of Risperdal and revoke its pediatric indication. Many Risperdal lawsuits have been filed on behalf of boys who developed gynecomastia. Risperdal was approved by the FDA in 2002 to treat schizophrenia, but was not cleared for use in children until 2006. Lawsuits also allege that Janssen, the manufacturer, knew about the risk but failed to warn doctors.
In January 2015, a Risperdal lawsuit claimed that Janssen (a subsidiary of Johnson & Johnson) withheld information linking Risperdal to incidences of breast growth in adolescent boys at least six years before the medication’s label was updated to indicate the risk.
At the trial brought by the family of Austin Pledger, a doctor testified that J&J failed to adequately warn physicians about the risks associated with the drug. The lawsuit indicated that the FDA asked Janssen to turn over the information in a request that was never included on the citizen petition docket, and Janssen responded in April 2013, saying the company hadn’t identified any information it had wrongfully withheld from the agency, according to Law360.
Since the Pledger lawsuit was filed, two juries in Philadelphia found that Janssen did indeed fail to warn doctors about gynecomastia. Only one of the juries, however, decided against Janssen. The other jury found there wasn’t enough evidence to prove that Risperdal caused male breast growth. As of March 2015, there were about 1,300 lawsuits consolidated in the Philadelphia Court of Common Pleas.
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