Category Archives: Caregiving – General

Delirium (from hospitalization or illness) accelerates memory loss

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This press release out of Beth Israel Deaconess Medical Center (bidmc.org) in Boston will be of interest to those dealing with dementia.

The press release reports on a study that:

“…confirms that an episode of delirium rapidly accelerates cognitive decline and memory loss in Alzheimer’s patients. … Delirium often develops in elderly patients during hospitalization or serious illness, and this acute state of confusion and agitation has long been suspected of having ties to Alzheimer’s disease and other dementias.”

The press release is copied below.

Robin
_____________________________

www.bidmc.org/News/InResearch/2009/April/DeliriumandDementia.aspx

Delirium Accelerates Memory Loss in Patients With Alzheimer’s Disease
Acute state of confusion and disorientation often complicates hospitalizations for patients with dementia
Beth Israel Deaconess Medical Center, Boston, MA
Press Release
Date: 5/4/2009

BOSTON ­ Delirium often develops in elderly patients during hospitalization or serious illness, and this acute state of confusion and agitation has long been suspected of having ties to Alzheimer’s disease and other dementias. Now a study led by researchers at Beth Israel Deaconess Medical Center (BIDMC) and Hebrew Senior Life confirms that an episode of delirium rapidly accelerates cognitive decline and memory loss in Alzheimer’s patients. The findings are reported in the May 5 issue of the journal Neurology.

“The cognitive rate of decline was found to be three times more rapid among those Alzheimer’s patients who had had an episode of delirium than among those who did not have such a setback,” according to lead author Tamara Fong, MD, a staff neurologist at BIDMC and Assistant Scientist at the Institute for Aging Research, Hebrew Senior Life. “In other words, the amount of decline you might expect to see in an Alzheimer’s patient over the course of 18 months would be accelerated to 12 months following an episode of delirium.”

Alzheimer’s disease is an irreversible, progressive form of dementia that gradually destroys a person’s ability to carry out even the simplest of tasks, and affects as many as 4.5 million individuals in the U.S. according to figures from the National Institute on Aging. There is currently no cure for Alzheimer’s disease.

Delirium, on the other hand, is a potentially preventable condition, which often develops following a medical disturbance, surgery or infection and is estimated to affect between 14 percent and 56 percent of all hospitalized elderly patients.

The investigators performed a secondary analysis of data gathered from 408 patients examined between 1991 and 2006 at the Massachusetts Alzheimer’s Disease Research Center (MADRC). Over this 15-year period, MADRC staff conducted a number of memory tests on patients. Testing was done on at least three occasions, separated by intervals of approximately six months. Seventy-two of the participants developed delirium during the course of the study.

In their final analysis, the authors found that among patients who developed delirium, the average decline on cognitive tests was 2.5 points per year at the beginning of the study; following an episode of delirium, decline nearly doubled to 4.9 points per year.

“Although each dementia patient declines at his or her own individual rate, the results of our study tell us that this rate can increase three-fold following an episode of delirium,” says Fong. “As an example, suppose an Alzheimer’s patient begins with mild symptoms, such as forgetting appointments or details of conversations, but over a period of the next 18 months, loses the ability to identify relatives, becomes lost while driving familiar routes, or can no longer balance a checkbook or manage financial transactions. This same patient, were he or she to experience an episode of delirium, might experience this same rate of decline in only 12 months.”

While further investigations are needed to determine the mechanism behind this turn-of-events, Fong explains that delirium may, in fact, be a key link in a chain of events that results in injury to brain cells. “Older patients may be at greater risk of developing delirium ­ particularly in the hospital setting ­ because they tend to have less ‘reserve’ or ability to compensate in settings of increased stress. Consequently, infections, new medications and other stressors put the patient at risk for delirium.”

All elderly patients, but particularly patients who have already been diagnosed with Alzheimer’s disease, can benefit from a number of preventive measures if they are hospitalized, notes Fong.

“As much as possible, it’s important to try and orient the patient to his or her surroundings [i.e. frequently remind the patient that he or she is in the hospital], to allow for as much uninterrupted sleep as possible by not waking patients to take vital signs or do blood draws at night, and to get patients out of bed and walking as soon as their medical condition allows,” notes Fong. Also, important, she adds, is to avoid use of unnecessary medications.

“Twenty percent of all elderly patients who develop delirium go on to experience complications, whether it’s a prolonged hospital stay, a move to a rehabilitation center or long-term care facility, or even death,” notes Fong. “Our current study now shows that delirium can also adversely impact the state of cognitive decline in patients with Alzheimer’s disease. Because up to 40 percent of delirium episodes can be prevented, taking steps to avoid delirium could result in significant improvements.”

This study was funded, in part, by grants from the Massachusetts Alzheimer’s Disease Research Center, the National Institute on Aging, and the Alzheimer’s Association, and the VA Rehabilitation Career Development Award.

Study coauthors include BIDMC investigators Edward Marcantonio and Sharon Inouye; Hebrew Senior Life investigators Richard Jones, Peilin Shi, James Rudolph, Frances Yang and Douglas Kiely; and Liang Yap of Massachusetts General Hospital.

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks in the top four in National Institutes of Health funding among independent hospitals nationwide. BIDMC is a clinical partner of the Joslin Diabetes Center and a research partner of the Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.org.

 

FDA Orders Black-Box Warning for Botox (4/30/09)

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Many in our local support group use Botox to treat blepharospasm (closing of the eyelids), drooling, painful joint contractures, dystonia, and rigid muscles. The FDA issued an order today requiring a black-box warning on Botox and its newly-approved competitor Dysport. Such “drugs must carry warning labels explaining that the material has the potential to spread from the injection site to distant parts of the body — with the risk of serious difficulties, like problems with swallowing or breathing.”

www.nytimes.com/2009/05/01/business/01botox.html

F.D.A. Orders Warning Label for Botox
By Natasha Singer
Published: April 30, 2009
New York Times

Botox and other similar antiwrinkle drugs must now carry the most stringent kind of warning label, the Food and Drug Administration said Thursday.

The F.D.A. issued that order the day after the agency approved a new drug, Dysport, that is expected to be the first real challenger to Botox in the United States. Like Botox, Dysport is an injectable drug derived from the paralytic agent botulinum toxin.

The F.D.A. said such drugs must carry warning labels explaining that the material has the potential to spread from the injection site to distant parts of the body — with the risk of serious difficulties, like problems with swallowing or breathing.

Requiring a drug to carry a box with bold-face risk information — a so-called black-box warning — is one of the strongest safety actions the F.D.A. can take. Black boxes are typically reserved for medications known to have serious or life-threatening risks. Antidepressants, for example, carry black boxes warning of the increased danger of suicidal thoughts and actions.

The F.D.A. said it would also require makers of injectable toxins to send doctors letters warning of their risks and to produce a medication guide to be given to patients at the time of injection.

In a conference call with reporters on Thursday, an F.D.A. official said that the problems had occurred mainly in patients who received overdoses of the drug for unapproved treatments, like limb spasticity in children with cerebral palsy.

Botulinum toxins are safe when administered for approved uses at approved doses, said Dr. Ellis F. Unger, an official at the agency’s office of new drugs.

The agency’s approval of Dysport, manufactured by Ipsen, based in Paris, portends a fierce competition in the United States toxin market of a sort that has been raging in Europe for years.

Last year, Botox had worldwide sales of about $1.3 billion, according to its maker, Allergan. Dysport had sales of $189 million, according to an earnings statement from Ipsen.

In the absence of serious competition, Allergan has been able to raise the drug’s price annually. But Dysport, which in Europe has been priced lower than Botox, has the potential to capture up to 20 percent of the market in this country, said David M. Steinberg, an analyst at Deutsche Bank.

“Many doctors have been clamoring for another option,” Mr. Steinberg said.

Injectable botulinum toxins are purified forms of the bacterial poison that causes botulism, a paralyzing disease that can be fatal. The drugs temporarily reduce or halt muscle activity.

In the last 20 years, the F.D.A. has approved Botox to treat crossed eyes, eyelid spasms, severe underarm sweating, and cervical dystonia, a neck problem that can cause severe pain and abnormal head position. Under the name Botox Cosmetic, the drug is also approved to treat frown lines.

In 2000, the agency approved a different type of the toxin, Myobloc, to treat cervical dystonia.

On Wednesday, the agency approved Dysport for frown lines and cervical dystonia.

Medicis Pharmaceutical, a company in Scottsdale, Ariz., that has the rights to sell Dysport for frown lines in the United States, said it planned to bring the drug to market within 60 days. Ipsen will market the drug in this country for the neck problem.

The new F.D.A. requirement for a black-box warning on such drugs comes 15 months after the agency received a petition from Public Citizen, a public advocacy group, calling for more substantial warnings.

In its petition, the group said that the F.D.A. had received reports of 180 serious health problems and 16 deaths connected to the injections. In a response sent to the group on Thursday, the agency said it had identified even more reports of complications, including 225 reports of problems caused by the drug spreading from the injection site to distant parts of the body.

“There would have been fewer problems caused if they had put this out a year ago,” said Dr. Sidney M. Wolfe, the director of the health research group at Public Citizen.

Allergan shares fell 1.3 percent to $46.66 on Thursday, while shares of Medicis rose more than 18 percent, to $16.07.

“A Life Worth Living” – Radio Interview and Book

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Sadly, the loved ones of five local support group members died in March; one support group member (caregiver) died too. At least one group member was involved in end-of-life treatment decisions, and relied on her husband’s written wishes when he was no longer able to communicate.

Along these lines, I heard a book author interviewed today (Thursday 4/2/09) on NPR’s “Fresh Air” program, and wanted to pass the info along to all of you. The book is “A Life Worth Living,” and the author is Robert Martensen, MD. Dr. Martensen was an ER and ICU MD for many years; he’s also a bioethicist.

In his book he talks about his father’s hospital death, and “argues that safeguarding the quality of a patient’s life sometimes trumps the urge to sustain life at all cost.” He also addresses his father’s death in the “Fresh Air” interview as well as his mother’s impending death. His mother lives in Santa Cruz. In the story about his mother, he describes one of his mother’s first MDs in these final weeks who wanted to place a pacemaker. Dr. Martensen worries that it’s only because he is an MD that he was able to know the right questions to ask the treating physician. Ultimately, he’s very fortunate that both of his parents had given such clear advance directives about what sort of treatment they wanted, given certain circumstances. He contrasts his mother with another elderly woman also suffering from dementia.

I would recommend listening to the 40-minute “Fresh Air” interview. You can find it online here:

http://www.npr.org/templates/story/story.php?storyId=102638208
The interview is titled “The Ethical Way To Heal American Health Care,” which doesn’t really capture the interview.

“Treating an Illness Is One Thing. What About a Patient With Many?”

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This is a good article in a recent New York Times (nytimes.com) about patients with many illnesses, not just one.  A key problem is that these patients end up on many medications.  Here’s an excerpt:

“Doctors know that it’s not right for someone to be on 15, 18, 20 medications,” said Dr. Tinetti, the Yale geriatrician. “But they’re being told that that’s what’s necessary in order to treat each of the diseases that the patients in front of them have.”

Here’s a link to the full article:

http://www.nytimes.com/2009/03/31/health/31sick.html

Treating an Illness Is One Thing. What About a Patient With Many?
Brendan Smialowski
The New York Times
March 30, 2009

Thanks to online friend Joe Blanc for making me aware of this article.

Robin

 

 

FDA warning – transdermal patches with metallic backings

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This advisory came out today. I have confirmed with Novartis that the Exelon patch does not contain a metallic backing. (Exelon is a dementia medication.) I don’t know about Fentanyl or scopolamine. Maybe someone else can find out??

http://www.fda.gov/cder/drug/advisory/t … lpatch.htm

FDA Public Health Advisory
Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings
Dated 3/5/09

The FDA has been made aware of information about certain transdermal patches (medicated patches applied to the skin) that contain aluminum or other metals in the backing of the patches. Patches that contain metal can overheat during an MRI scan and cause skin burns in the immediate area of the patch.

Transdermal patches slowly deliver medicines through the skin. Some patches contain metal in the layer of the patch that is not in contact with the skin (the backing). The metal in the backing of these patches may not be visible. The labeling for most of the medicated patches that contain metal in the backing provides a warning to patients about the risk of burns if the patch is not removed before an MRI scan. However, not all transdermal patches that contain metal have this warning for patients in the labeling.

FDA is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan.

Until this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan. MRI facilities should follow published safe practice recommendations concerning patients who are wearing patches.1,2

Until this safety issue is resolved, FDA recommends that patients who use medicated patches (including nicotine patches) do the following:

* Tell the doctor referring you for an MRI scan that you are using a patch and why you are using it (such as, for pain, smoking cessation, hormones)

* Ask your doctor for guidance about removing and disposing of the patch before having an MRI scan and replacing it after the procedure.

* Tell the MRI facility that you are using a patch. You should do this when making your appointment and during the health history questions you are asked when you arrive for your appointment.

The FDA urges health care professionals and patients to report possible cases of skin burns while wearing patches during an MRI to the FDA through the MedWatch program by phone (1-800-FDA-1088) or by the Internet at http://www.fda.gov/medwatch/index.html.

(1) Kanal, et. al, “ACR Guidance Document for Safe MR Practices: 2007,” AJR 2007; 188:1­27.
(2) Guidelines for Screening Patients For MR Procedures and Individuals for the MR Environment, Institute for Magnetic Resonance Safety, Education, and Research, www.imrser.org, 2009.