The anti-psychotic drug Risperdal (risperidone) has been linked to an increased risk of stroke and death in older patients with dementia. Janssen recently was ordered to pay $2.2 billion to the Justice Department for concealing these risks.
Need a Texas Risperdal Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by Risperdal, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit in Texas.
Black Box Warning for Stroke
The Prescribing Information for Risperdal (risperidone) includes a “Black Box” warning about the risk of cerebrovascular events (deadly strokes and transient ischemic attacks) in elderly patients with dementia-related psychosis. Risperdal is not approved for use in elderly patients with dementia.
Risperdal Stroke Warnings Concealed
In November 2013, the U.S. Department of Justice (DOJ) and Janssen Pharmaceuticals reached a $2.2 billion settlement. Prosecutors found that Janssen used illegal marketing tactics to promote Risperdal for use in elderly patients from 1999-2005 without providing adequate warnings about stroke.
The government alleged that the FDA told Janssen that marketing Risperdal as safe and effective for elderly patients would be “misleading.” The FDA also cautioned Janssen that elderly people with dementia did not necessarily have psychotic disorders, and treating them as such raised ethical questions about the use of an anti-psychotic drug for behavior control.
In addition, the government alleged that Janssen knew that Risperdal posed serious health risks to the elderly — including the increased risk of stroke. However, drug-makers downplayed these risks.
For example, in 2003, a clinical trial linked the use of Risperdal in elderly patients to an increased risk of stroke. Instead of publishing the data, Janssen provided “pooled data” from multiple studies to make it seem like there was a lower overall risk of adverse events. A year later, the study still was not published. One physician who worked on the study wrote:
“At this point, so long after RIS 232 has been completed, I think it is wrong to continue to submit abstracts of the three pooled studies. At this point, we must be concerned that this gives the strong appearance that Janssen is purposely withholding the findings from RIS 232.”
Strokes happen when the flow of blood to part of your brain is cut off by a blood clot (ischemic stroke) or bleeding in the brain (hemorrhagic stroke). If blood-flow is not restored in a few minutes, brain cells (neurons) are starved of oxygen and begin to die. This causes permanent brain damage.
Transient Ischemic Attack
Transient Ischemic Attack, also known as a “mini-stroke,” occurs when a blood clot temporarily blocks circulation of blood to the brain — usually for less than 5 minutes. It produces similar symptoms as a stroke.
- Sudden muscle weakness, numbness, or paralysis (drooping side of the face, arm, or leg, typically on one side of the body)
- Slurred speech or problems understanding speech
- Sudden blindness, double vision in one or both eyes
- Dizziness, loss of balance
- Sudden, severe headache with no known cause
Resources & Additional Information
- What is a Stroke? National Institute of Health (NIH)
- Questions & Answers About Stroke — National Institute of Neurological Disorders and Stroke
Need a Risperdal Lawyer in Texas?
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