Timeline
- 1993 – the U.S Food and Drug Administration (FDA) approved Johnson & Johnson’s Risperdal® for schizophrenia in adults and for short-term treatments for conditions associated with bipolar I disorder.
- 1996 – approximately a million prescriptions for Risperdal® were issued.
- 2002 – Janssen Pharmaceuticals issues warning to Canadian doctors regarding an increased risk of stroke associated with Risperdal® in elderly dementia patients. Risperdal® is allegedly responsible for at least 37 cases of stroke-like incidents, including 16 deaths.
- 2003 – Janssen Pharmaceuticals issues same warning to American doctors.
- 1993- 2004 – Allegations that Johnson & Johnson illegally marketed Risperdal® before obtaining FDA approval arise.
- 2005 – Black box warning label (the most severe warning a medication can have) was required by the FDA. Risperdal® reaches $2.1 billion in annual sales as doctors continue to prescribe drugs for non-approved (off-label) use, which include treatments for conditions such as autism, Alzheimer’s and ADD.
- 2006– a clinical study revealed links to Risperdal® and the risk of developing gynecomastia, a condition that causes male breast tissue enlargement.
- 2007 – FDA approved Risperdal® for schizophrenia in teenagers.
- 2012 – Johnson & Johnson settles claims of misconduct for $181 million in Kentucky, $159 million in Texas, and $5.9 million in Montana (2 years later in 2014). These were a result of lawsuits alleging Johnson & Johnson concealed dangerous side effects of Risperdal
- 2014 – new study links the increased risk of developing gynecomastia in adult men after taking Risperdal®