Black-Box Warning Effects Wisconsin Family
Posted by PKSD Law Firm on Nov 24, 2008 in Dangerous Drugs
The Milwaukee Journal Sentinel recently ran an article covering black-box warnings on prescription medications and the effect it had on one Wisconsin family.
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In case you were unaware, a black-box warning is a type of warning that appears on prescription drugs. The name is derived from the black border that usually surrounds the text of the warning. It means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.
The article discussed the long-term care issues of Bruce Bowman, 71, while he was a resident at Taylor Park Nursing Home Rehabilitation Center in Rhinelander, WI.
Mr. Bowman suffered from dementia and passed away at the facility after a bout with pneumonia.
Approximately 6 mos. before his death, Mr. Bowman was prescribed Risperdal, an anti-psychotic drug. Medical records show he was given the drug to subdue his agitation and physical aggression.
According to the article, Bowmans children say the nursing home staff never told them that Risperdal has a black-box warning which reads Increased mortality rate in elderly patients with dementia-related psychosis.
They also didn't know that in clinical trials most patient deaths occurred from cardiovascular or infectious complications, such as pneumonia.
Prior to giving Mr. Bowman his medication, the nursing home had the residents legal guardian sign a form outlining the medications risks.
The black-box warning for Risperdal was issued by the FDA in 2005, but the nursing home was using medication consent forms that were nearly 7-years-old so they didn't contain any language regarding the black-box warning.
The article goes on to say that the nursing home facility could've downloaded the updated forms from the state Department of Health Services Web site. Unfortunately, the forms arent required in nursing homes.
Residents and their health care agents are supposed to be informed about the services and medications being provided so they can make informed decisions.