January 27, 2015 — The doctor who prescribed Risperdal to a child who developed gynecomastia has testified that he would have re-evaluated his decision if Janssen Pharmaceuticals had adequately warned about the side effect.
According to Law360, clinical professor Jan Mathisen of the University of Alabama prescribed Risperdal “off-label” to 8 year-old in July 2002. After taking Risperdal for four years, he developed gynecomastia (female breasts).
At the time, the label on Risperdal warned that some adults developed elevated levels of the pregnancy hormone prolactin, which can stimulate breast growth and milk production in boys. However, the label indicated that gynecomastia was a rare side effect seen in just one out of every 1,000 patients.
Mathiesen said a sales representative for Janssen Pharmaceuticals visited him 20 times between 2002 and 2004, and left samples of Risperdal, according to Law360.
In 2013, federal prosecutors for the Justice Department accused Janssen of engaging in illegal “off-label” marketing between 1999 and 2005. They allegedly instructed sales representatives to target child psychiatrists and promote Risperdal as a safe and effective treatment for children.
Risperdal was not approved for the treatment of children until 2006. Mathiesen said he still prescribes Risperdal for children, but now he clearly warns families about the risk of gynecomastia. Because he did not know about the risk in 2002, his family was never warned.