An ex-chief of the US Food and Drug Administration has testified in a Philadelphia lawsuit that Johnson & Johnson knew as early as 2001 that its popular antipsychotic medication Risperdal (risperidone) would “probably or very likely” cause as many as 3.8% of boys who took it to grow breasts, reported FiercePharma.
J & J did not add the warning to the drug’s official label until five years later. An autistic 20-year-old Philadelphia man is now suing J & J, stating that he needs a mastectomy as a result of being put on Risperdal when he was a child. “There are more than 1,250 Risperdal lawsuits pending in courts throughout the country, most of which related to abnormal breast growth in young men,” stated a law firm handling some of the cases.
J & J previously paid $2.2 billion to settle a federal lawsuit that, in part, involved allegations that the company illegally promoted Risperdal for unapproved uses in children and adolescents. In recent years, the company has been facing lawsuits from males who took the drug and were not warned that the side effects included the possibility they would grow breasts, reported FiercePharma.
According to the law firm Pintas and Mullins, of 1,250 pending cases, six cases were “selected as bellwether trials in 2012; however, Janssen (a unit of J & J) agreed to settle these cases before they went before juries. Janssen agreed to settle another 80 cases in early 2013.”
“I’m just having a hard time right now,” the Philadelphia boy’s mother told the Philadelphia Inquirer, crying after a day in court. “Hearing what the pharmaceutical company was doing.”
Healio reported on four other similar cases going on currently in Connecticut, Florida, Maryland and Ohio. “The bodies of these young men have been permanently mutated by Risperdal,” an attorney said in a press release. “In a young man who is already isolated by his challenges caused by mental issues, the growth of women’s breasts on his body in adolescent and teenage years is absolutely devastating.”
J&J again faces off-label marketing claims in Risperdal case of boy who grew breasts (FiercePharma, January 26, 2015)
Ex-FDA chief testifies against J&J in Risperdal liability case (FiercePharma, January 29, 2015)
Mother brought to tears hearing Johnson & Johnson’s Risperdal tactics (Philadelphia Inquirer, January 30, 2015)
Lawsuit against Janssen alleges Risperdal caused gynecomastia (Healio, January 28, 2015)
Risperdal Breast Growth Case Begins in Alabama (Pintas & Mullins Law Firm, January 26, 2015)
Every one I see who is taking Risperidone has without fail raised prolactin so it is hardly surprising. I check every one now and use it as leverage for doing some dose reduction.
I don’t want to cause panic but I wonder if such tissue hypertrophy and hormonal mess may not lead to higher risk of infertility and/or cancer…
I hope it’s not the case but messing up with sex hormones during puberty is a really bad idea.
I am getting so sick of hearing about this. It’s a completely benign and irreversible “side effect”, unlike brain damage and the subsequent neurological problems (such as tardive dyskinesia) that result from it. It pains me to see that lawyers and the public and even our government makes such a big deal out of boys with breasts, but permanent brain damage and life-long torturous neurological problems are still apparently no big deal… but breasts apparently are. Shameful and sickening. If you want to make a big deal out of boys growing breasts on these drugs, make a big deal out of BRAIN DAMAGE CAUSED BY THESE DRUGS first.
“It’s a completely benign and REVERSIBLE* “side effect”
Honestly, f that leads to people being more reluctant to put kids on these drugs it’s already a win.
I totally disagree. I don’t want to live in a world where a purely cosmetic “side effect” is taken so seriously my people, especially courts, while real torturous, damaging and even life destroying brain damages are glossed over as being irrelevant.
Oh no, Little Johnny cant stop grunting and smacking himself in the chest and he’ll be this way for the rest of his life now. Oh well, life goes on. Oh no, Little Johnny needs a simple $2,000 surgery to remove some fatty tissue from his chest and then he’ll be back to normal. What a catastrophe of a tragedy, this calls for billion dollar lawsuits!
Can’t argue with you. It’s beyond odd that something like Tardive Dyskenesia is barely mentioned, and that the establishment is upset when telling people their drugs might cause suicide or homicide reduces prescription rates, but we’re very upset about male breast development. Maybe it’s a distraction tactic so that it can seem like they care when we know they really don’t.
Still, anything that makes people question the validity of these “treatments” is a good thing in my book.
Gynecomastia from neuroleptic, atypical antipsychotic drug exposure– the development of breast tissue in boys, is neither benign nor necessarily reversible. It can be a permanent mutation of a boy or man’s body. Some boys who have had mastectomies (to remove tissue) end up having tissue grow back again. Children or adults suffering from this drug induced condition, and children who are developmentally disabled in some say with self harming behaviors do not deserve either rage, envy or ridicule.
That front group for the pharmaceutical industry “NAMI” was pushing Risperdal on kids.
Then this guy “Biederman” was the recipient of the 1998 NAMI Exemplary Psychiatrist award.
Psychiatrist Joseph Biederman had been under a U.S. Senate investigation in 2008 for earning at least $1.6 million in consulting fees from drug makers yet had failed to report all but about $200,000 of this income to Harvard university officials.
Its such a tangled web. It just sucks for Risperdal victims.
My doctors claimed in a 1.8.2002 medical record that Rispedal was a “Foul up” drug, they learned it causes “psychosis” in a percentage of the population. Did they report this serious adverse effect of Risperdal so they could protect other patients? Hell no, they did everything in their power to cover up the serious adverse effects of Risperdal. I’m sorry to all who were harmed by Risperdal, in all ways, and shame on the doctors who are still covering up the adverse effects of this brain damaging, tardive akathesia and dyskinesia causing, psychosis causing, diabetes causing, extreme weight gain inducing, gynecomastia causing toxic drug. And shame on the lawyers who aren’t taking cases, except for those related to gynecomastia.