Navigation Links
FDA Warns About Antipsychotic Drugs and Elderly

The Food and Drug Administration (FDA) today issued a public health advisory to alert health care providers, patients, and patient caregivers to new safety information concerning an unapproved (i.e., "off-label") use of certain drugs called "atypical antipsychotic drugs." These drugs are approved for the treatment of schizophrenia and mania, but clinical studies of these drugs to treat behavioral disorders in elderly patients with dementia have shown a higher death rate associated with their use compared to patients receiving a placebo (sugar pill).

Today's advisory applies to such antipsychotic drugs as Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine), Risperdal (risperidone), Clozaril (clozapine) and Geodon (ziprasidone). Symbyax, which is approved for treatment of depressive episodes associated with bipolar disorder is also included in the agency's advisory.

FDA is requesting that the manufacturers of all of these kinds of drugs add a boxed warning to their drug labeling describing this risk and noting that these drugs are not approved for the treatment of behavioral symptoms in elderly patients with dementia. Patients receiving these drugs for treatment of behavioral disorders associated with dementia should have their treatment reviewed by their health care providers.
In analyses of seventeen placebo-controlled studies of four drugs in this class, the rate of death for those elderly patients with dementia was about 1.6 to 1.7 times that of placebo. Although the causes of death were varied, most seemed to be either heart-related (such as heart failure or sudden death) or from infections (pneumonia).

The atypical antipsychotics fall into three drug classes based on their chemical structure. Because the increase in mortality was seen with atypical antipsychotic medications in all three chemical classes, the agency has concluded that the effect is probably related to the common pharmacologic effects of all atypical an tipsychotic medications, including those that have not been studied in the dementia population.

The agency is considering adding a warning to the labeling of older antipsychotic medications because limited data also suggest a similar increase in mortality for these drugs. The review of the data on these older drugs, however, is still on-going.


Source:U.S. FDA

Related biology news :

1. FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media
2. WHO Warns Of Increased Risk Of Vector-borne Diseases In Tsunami-affected Areas
3. HIV Patients May Be at Risk of Heart Problems When Taking Protease Inhibitor Drugs
4. New Drugs For Bad Bugs: UF Approach Could Bolster Antibiotic Arsenal
5. FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
6. Computational Tool Predicts How Drugs Work In Cells, Advancing Efforts To Design Better Medicines
7. Discovery of New Dopamine Action May Yield Alternative Psychiatric Drugs
8. Drugs from the deep blue
9. Engineered Stem Cells Show Promise For Sneaking Drugs Into The Brain
Post Your Comments:

(Date:11/18/2015)... 18, 2015 --> ... new market report titled  Gesture Recognition Market - Global ... - 2021. According to the report, the global gesture recognition market was ... to reach US$29.1 bn by 2021, at a CAGR ... North America dominated the global gesture recognition ...
(Date:11/17/2015)... Paris , qui s,est tenu ... Paris , qui s,est tenu du 17 au ... l,innovation biométrique, a inventé le premier scanner couplé, qui ... même surface de balayage. Jusqu,ici, deux scanners étaient nécessaires, ... digitales. Désormais, un seul scanner est en mesure de ...
(Date:11/17/2015)... Pressure BioSciences, Inc. (OTCQB: PBIO) ("PBI" and ... of broadly enabling, pressure cycling technology ("PCT")-based sample preparation ... it has received gross proceeds of $745,000 from an ... "Offering"), increasing the total amount raised to date in ... are expected in the near future. ...
Breaking Biology News(10 mins):
(Date:12/1/2015)... 2015 Today the Allen Institute announced the ... South Lake Union neighborhood, the city,s biotechnology ... and Westlake Avenue North, the 270,000 square foot life ... Brain Science and the Allen Institute for Cell Science. ... of the Allen Institute. "We started by building a ...
(Date:12/1/2015)... Dec. 1, 2015 Frost & Sullivan ... This program addresses ways companies can innovate and ... --> ... --> ... as well as the disrupting factors altering the ...
(Date:12/1/2015)... 01, 2015 ... the "2016 Europe Cell Surface Markers: ... Competitive Strategies, Opportunities for Suppliers--France, Germany, Italy, ... --> ) has announced ... Cell Surface Markers: Country Volume and Sales ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... ... provider, announces that its best selling system laboratory animal colony management software solution, ... today, without investing in on-site IT resources., , Many ...
Breaking Biology Technology: