Posts Tagged ‘clinical trial’

Science Daily: Almost 1/3 of U.S. nursing home residents received antipsychotic drugs as chemical restraints

Wednesday, June 2nd, 2010

Illinois Nursing Home Abuse Blog
By Levin & Perconti

Science Daily is reporting that a study shows that newly admitted elderly patients to nursing homes have a higher rate of being prescribed antipsychotic drugs than in previous years. This study found that in 2007, almost one-third of U.S. nursing home residents received antipsychotic drugs. The FDA has issued a warning that there is a great risk of death among older adults with dementia who are taking these agents to control behavioral symptoms. A recent clinical trial has concluded that the adverse effects of atypical antipsychotic drugs have outweighed the benefits of those with Alzheimer’s. This shows that many doctors are over prescribing these drugs, and it is having an adverse effect on patients.

The nursing home study found that about 30 percent of the residents in the study received at least one antipsychotic medication in 2006 and 32 percent of those did not have dementia or another indication that they needed to be on this medication. Some experts believe that the organizational culture of the nursing homes may encourage the prescribing of antipsychotic. Hopefully, the FDA warning and other studies will move the prescription statistics in the opposite direction. If not policies may have to target those nursing homes that have a high antipsychotic prescription rate so as to improve patient care. To read more about the nursing home study, please click the link.

Read entire article:  http://blog.levinperconti.com/2010/05/antipsychotic_medications_are.html

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FDA says Pfizer overdosed 13 children in antipsychotic drug trial

Tuesday, April 20th, 2010

Reuters
April 20, 2010

U.S. health regulators have warned Pfizer Inc. over a series of failures that led to the overdosing of at least 13 children in a clinical trial of its antipsychotic drug Geodon, according to a letter made public on Tuesday.

The FDA, in an April 9 warning letter to the world’s largest drugmaker, said Pfizer “failed to ensure proper monitoring of the investigation” for a product.

The agency did not name the drug in the public version of the letter, but Pfizer confirmed it related to the use of Geodon in children with bipolar disorder.

It said the company did not properly monitor the study and, “as a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner.”

Several children given overdoses experienced tremors, restless legs and other complications, the letter said.

Pfizer recognizes the issue’s seriousness and is committed to addressing the concerns, it said. Pfizer reported many items cited in the letter as many as four years ago, it said.

Since then it “has instituted several new measures designed to improve monitoring and execution of clinical trials, including our oversight of clinical investigators,” it said.

Read entire article:  http://www.reuters.com/article/idUSTRE63J4XQ20100420

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