Risperdal (risperidone) is a powerful anti-psychotic drug that significantly increases the risk of stroke and transient ischemic attacks (mini-strokes) when given to elderly dementia patients.
Risperdal and Stroke
Risperdal (risperidone) is not approved to treat elderly patients with dementia because studies have shown that it increases their risk of stroke and death. The label on Risperdal carries a Boxed Warning — the strongest warning the FDA can require — about the danger of cerebrovascular events (deadly strokes and transient ischemic attacks) in elderly patients with dementia-related psychosis.
Janssen Pays Billions for Concealing Risperdal Stroke Risk
In November 2013, the U.S. Department of Justice (DOJ) reached a $2.2 billion settlement with Janssen Pharmaceuticals for concealing risk information and illegally marketing Risperdal and two other drugs.
Prosecutors allege that Janssen knew Risperdal could increase the risk of stroke in elderly dementia patients at least as early as 2003, when clinical trial RIS-232 was complete. However, the results of the study were not published for several years. In the meantime, Janssen provided only “pooled data” from four clinical trials in a way that made it seem like the overall risk of adverse events was lower.
When a scientist involved in RIS-232 became concerned that the study was not being published, he warned:
“At this point, so long after RIS 232 has been completed … we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings from RIS 232.”
A stroke is a medical emergency that occurs when the flow of oxygen-rich blood to the brain is cut off. There are two major types of stroke: hemorrhagic stroke, which involves bleeding in the brain, and ischemic stroke, which involves blood clots in the brain.
Transient Ischemic Attacks
Risperdal is also associated with “mini-strokes,” or transient ischemic attacks, which occur when a blood clot temporarily cuts off blood-flow to the brain, usually for 5 minutes or less.
If blood-flow is not restored within a few minutes, brain cells (neurons) begin to die and brain damage occurs. The type of complications vary depending on the part of the brain that is damaged, but over two-thirds of stroke survivors have some disability.
Stroke complications may include:
- Muscle weakness
- Paralysis (usually on one side of the body)
- Speech problems
- Intellectual disability
- Memory loss
- Organ damage
- And more