Navigation Links
FDA Orders Warning Label on Older Antipsychotics
Date:6/16/2008

Drugs increase risk of death among elderly patients with dementia, agency says

MONDAY, June 16 (HealthDay News) -- The U.S. Food and Drug Administration is cautioning physicians that certain types of antipsychotic drugs can boost the death risk of seniors with dementia.

Doctors sometimes use antipsychotics to help treat behavioral problems in demented patients.

But from now on these older, so-called "conventional" antipsychotics -- which include drugs such as thorazine and prolixin -- will carry a new black box warning alerting physicians of the danger, FDA officials announced Monday.

"We issued letters to all the manufacturers of antipsychotic drugs, both conventional and atypical, requiring them to update their labeling with new language for a box warning about an increased risk of death in elderly patients with dementia," Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products at the Center for Drug Evaluation and Research, said during an afternoon teleconference.

This is a new warning for conventional antipsychotics, but it is not new for another class of the medications, called atypical antipsychotics. Back in 2005, the FDA ordered warning labeling for those medications, which include newer drugs such as Zyprexa and Risperdal. That labeling warned of a higher risk for heart attack and pneumonia for elderly patients with dementia who received atypical antipsychotics.

This new black box warning for older, conventional antipsychotics is one of the first uses by the agency of the Food and Drug Administration Amendments Act of 2007, which gives the FDA authority to mandate drug warnings, something they could only request before.

According to Laughren, the FDA based its 2005 decision on a review of studies comparing their use to a placebo. At the time, a lack of evidence prevented the agency from extending the warning to conventional antipsychotics, Laughren said.

However, since then, observational studies have appeared that indicate that conventional antipsychotics carry the same risk, he said. "The data we have for observational studies are not ideal, so we struggled with this decision, but in the end decided that the data were strong enough to extend the warning to all drugs in this class," he said.

When looking at the data involving atypical antipsychotics, the FDA found that over 10 weeks, roughly 4.5 percent of patients with dementia taking these drugs died, compared with 2.6 percent of patients receiving a placebo, Laughren said.

Laughren noted that all these patients were very ill in their 80s and in nursing homes. The deaths appeared to be mostly from cancer or infections such as pneumonia.

One study by Canadian researchers, published in May in the Archives of Internal Medicine, found that elderly patients with dementia given atypical antipsychotics were 3.2 times more likely than individuals who had received no antipsychotic therapy to be hospitalized or to die during 30 days of follow-up.

Conventional antipsychotics, as well as atypical antipsychotics, are not approved for use in elderly patients with dementia, Laughren noted.

"Patients with dementia often have behavioral symptoms as well. They can have psychotic symptoms, such as delusions and hallucinations, they can be agitated, aggressive and at times violent, and antipsychotic drugs are sometimes used in treating these behavioral symptoms," Laughren said.

"We are not telling physicians that they absolutely cannot use these drugs in this setting," he added. "What we want to do is make them aware of this risk. This is something we hope they would discuss with the families and caregivers so they can understand that there are risks to using these drugs."

Both conventional and atypical antipsychotics are dopamine receptor agonists that work by blocking the action of dopamine in the brain. The primary differences between them are side effects, which are fewer among the atypical antipsychotics.

More information

For more on antipsychotic drugs, visit the U.S. Food and Drug Administration.



SOURCES: June 16, 2008, teleconference with Thomas Laughren, M.D., director, Division of Psychiatry Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>
Copyright©2008 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Plaintiffs Lawyer Orders Lead Testing on 3 Popular Herbalife Products; Results Show 728% More Lead Than Allowed by Law Under Proposition 65 Violation
2. Childrens Neck Size Associated With Sleep Disorders
3. Combat Vets Display Severe Sleep Disorders
4. Beyond Traditional Borders sends more Rice U. undergrads to Africa
5. Risk Factors for Eating Disorders Vary by Gender
6. Autism Author and Psychologist Dr. Jed Baker to Speak on Communication Disorders
7. Experts to discuss sleep science and the health risks of sleep disorders in Baltimore this June
8. New Treatment Guide for Eating Disorders Available to Healthcare Professionals
9. At the synapse: Gene may shed light on neurological disorders
10. Green Tea May Help Brain Cope With Sleep Disorders
11. The Anxiety Disorders Association of America and The HealthCentral Network Form Alliance to Develop New Online Resources for Anxiety Disorders
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Orders Warning Label on Older Antipsychotics
(Date:10/13/2017)... , ... October 13, 2017 , ... ... serving communities in the greater Dallas, Miami, and Raleigh regions, is organizing an ... to overcome a rare and deadly chromosome abnormality. , After struggling since birth ...
(Date:10/13/2017)... ... ... As health professionals work to improve their approach to healthcare, there is ... than filling out a survey; in many cases health professionals and patients are working ... and research on the importance of active engagement with patients and members of the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... The American Board ... become its next President and Chief Executive Officer, succeeding Dr. James C. Puffer upon ... beginning July 1, 2018 until Dr. Puffer’s retirement at the end of 2018. Upon ...
(Date:10/13/2017)... Las Vegas, Nevada (PRWEB) , ... October 13, 2017 , ... ... of 7® Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum ... CBD dose required and providing a CBD form that can be easily incorporated into ...
(Date:10/13/2017)... QUEENS, N.Y (PRWEB) , ... October 13, 2017 , ... ... recently became a member of ElderCounsel, a national organization of elder law and special ... constantly changing laws and rules. It also provides a forum to network with elder ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... 11, 2017  BioPharmX Corporation (NYSE MKT: BPMX) researchers ... an innovative way to use nonlinear optical imaging to ... new drugs. ... will show how researchers from BioPharmX and the Wellman ... used a suite of imaging techniques in what is ...
(Date:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... SEOUL, South Korea , Oct. 4, 2017 /PRNewswire/ ... launched its next-generation CPR training aide "cprCUBE" on Kickstarter. ... of chest compression during cardiac arrests with better efficiency ... patient-mannequins. It also offers real-time feedback on efficacy of ... The crowdfunding campaign has a goal to raise ...
Breaking Medicine Technology: