In Janssen's own clinical trials, 43 children developed the abnormal breasts
A drug used to treat ADHD children is causing concern in the United States.
It is called Risperdal and it is supposed to be used primarily for adults with sever psychological problems.
But last year it was prescribed more than 6.5 million times.
The side effects include young males developing female sex organs.
Nineteen-year-old John was just seven when he began taking Risperdal for ADD.
Even though the FDA approved the drug only for adult patients who were psychotic, John’s doctor and others widely prescribed it to kids for less severe behaviour problems.
Once taking Risperdal, John’s mum says he became aggressive, sleepy, and developed bowel problems. But the biggest shock came when he was 14 and started developing women’s breasts.
“He asked me if he was a girl,” she says.
It turns out Risperdal can increase production of a hormone called prolactin, which stimulates breast growth. It is called gynecomastia – and it is irreversible.
Risperdal and other so-called “atypical anti-psychotics” have exploded in use.
Hundreds of thousands of kids have been prescribed Risperdal in the 14 years it has been on sale – long before the FDA approved it for very limited pediatric use in 2006.
John and most of the other children were not psychotic at all, but were given Risperdal for behaviour disorders including autism and ADD.
Attorney Stephen Sheller is suing Janssen, which makes Risperdal. He claims Janssen marketed Risperdal for unapproved uses in children, downplayed serious risks like diabetes and seizures.
Janssen would not agree to an interview but told us the breast growth risk is “clearly stated in the FDA-approved” labelling, and “we only promote our products for their FDA-approved indications.”
Nobody knows how often it happens. But in Janssen’s own clinical trials with fewer than 2,000 children (1,885), 43 developed the abnormal breasts.
Mr Sheller represents John and nine other boys – one of whom was only four when he developed a breast on one side and began producing milk.
The treatment for the unbridled breast growth is as
unthinkable as the disorder: painful removal of the
breasts.
Eventually, the boys can appear normal again.
The family’s lawsuit is still in court.
But John’s mother says surgery did not fix all of the problems from the medicine.
When asked if John still thinks he’s a girl his mother wells up and cries before answering, “yes.”
As for Risperdal – it’s still on the market. And families say putting even more children at risk.