Many doctors are prescribing atypical antipsychotic drugs for elderly Alzheimer's/dementia patients who have behavioral and psychiatric symptoms or problems. This is in spite of the practice being condemned by all leading medical authorities and the FDA.

There are NO FDA approved drugs for the treatment of behavioral and psychiatric symptoms in elderly Alzheimer's dementia victims

Most authorities recommend that the use of medications or drugs to treat behavioral and psychiatric symptoms be considered with "extreme caution" and to be reserved as a treatment of last resort. Unfortunately it is frequently the first option considered. Many times it is used for the convenience of the medical or nursing staff. Most authorities also agree that the chances of success by using such drugs are low while a risk of death of a loved one looms on the horizon.. They are odds that no gambler would accept.

The cause of the behavioral and psychiatric symptoms should be carefully analyzed in an effort to determine the underlying cause. They may be caused by the:

(1.) Side effects of other drugs being used by the patient or victim.           

         The behavioral symptoms may also be traced to - 

(2.) Underlying medical problems. - Pain management - Comfort concerns -             

          Other significant causes may be - 

(3.) Environmental conditions.

          a. Moving to new residence, b. changes in the caregiver,  c. changes in the environment,  d. negative noise stimulation,  e. perceived threats etc.

The Nursing Home Reform Act of 1987  (Federal Law) stated, among other things, that:

"The resident has the right to be free from any physical or chemical restraints imposed for purposes of discipline or convenience, and not required to treat the resident's medical symptoms "

A chemical restraint is a reduction of the individual's ability to think and act independently by means of a powerful antipsychotic drug - Such a drug should never be used unless the reasons and parameters are specified in the care plan.

(1.)  The New York Times published an article June 24^th 2008 “Doctors Say Medication Is Overused in Dementia” “The use of antipsychotic drugs to tamp down the agitation, combative behavior and outbursts of dementia patients has soared, especially in the elderly. Sales of newer antipsychotics like Risperdal, Seroquel and Zyprexa totaled $13.1 billion in 2007, up from 4 billion in 2000...about a third of all nursing home patients have been given antipsychotic drugs. The increases continue despite a drumbeat of bad publicity.

A 2006 study of Alzheimer’s patients found that for most patients, antipsychotics provided no significant improvement over placebos in treating aggression and delusions....misuse of the drugs is widespread. “These antipsychotics can be overused and abused,” said Dr. Jonny Matson, a professor of psychology at Louisiana State University. “And there’s a lot of abuse going on in a lot of these places....Dr. William D. Smucker, a member of the American Medical Directors Association,...”.prescribe antipsychotics  only as a last resort”, he said, “many physicians are absent without leave in the nursing home and don’t take an active role in the assessment of the patient.”

(2.)  The St. Petersburg Times (Florida) ran an article on 18 November 2007 exposing this practice. "Dementia relief, with a huge side effect". The off-label use of some drugs is helping elderly patients, but may be killing thousands." Kris Hundley, Times Staff Writer.

The following is quoted from this article:

"Two years ago, federal regulators sounded a dire warning: Elderly people with dementia who take drugs like Seroquel, Risperdal and Zyprexa could suffer the ultimate side effect.. They could die.

Yet today, about one in four nursing home residents still take these antipsychotic drugs. Sales to the elderly continued to rise, generating a total of $13-billion in revenues for their manufacturers this year.

The disconnect between government warnings about the increased risk of death and physician prescribing practices led to a prominent Food and Drug Administration safety expert to make a stunning estimate

Dr. David Graham, who had blown the whistle on the dangers of Vioxx, was back before a congressional panel in February. He testified that Zyprexa and other antipsychotics kill about 15,000 nursing home residents each year."

Dr. Graham was quoted: "I would pay careful attention to antipsychotic medications....The problem with these drugs are that we know that they are being used extensively of label in nursing homes to sedate elderly patients with dementia and other types of disorders.....But the fact is, is that it increased mortality perhaps by 100 percent. It doubles mortality. So I did a back of the envelope calculation on this and you have probably got 15,000 elderly people in nursing homes dying each year from the off label use of antipsychotic medications....With every pill that gets dispensed in a nursing home, the drug company is laughing all the way to the bank."

He talked about the FDA's Black Box Warning. "So named because of the black border that surrounds it on the drug label. It's the FDA required disclosure that a drug can have serious or life threatening side effect. What drugs got black box warnings? Abilify, Zyprexa, Seroquel, Risperdal, Clozaril, Geodon and Symbyax."

      Note: As of June2008, the older antipsychotic drugs have also been added to the list of those requiring the black box warning. "The U.S. Food and Drug Administration on Monday cautioned doctors that certain types of antipsychotic drugs can raise the risk o death in some elderly people with dementia. The older conventional  antispychotic drugs include Haldol (Johnson & Johnson), Moban (Endo Pharmaceutical Holdings Inc.) and Navane (Pfizer Inc.), according to a database on the FDA's website. In year 2005, a similar warning was issued for newer or "atypical" anti-psychotics, including Abilify, Zyprexa and Risperdal. The FDA official said that from now on old class of antipsychotic drugs will include a strong "blackbox" warning, cautioning physicians of the danger. Antipsychotic drugs are used now and then by physicians to help treat behavioral problems in dementia patients." (The MedGuru June 17, 2008)  (Also included as subjet to the black box warnings are antipsychotics Compazine, Loxitane, Mellaril, Orap, Prolixin, Stelazine, Thorazine and Tilafon.)

(3.)  The U. S. Department of Health's CMS (Centers for Medicare and Medicaid Services) has issued a revised Surveyor Guidance for Unnecessary Medications (F329) that contains a very alarming statement: (`12/18/2006)

"Report (2001) Fifty –eight (58) percent of 693,000 residents who received antipsychotics either

- Lacked appropriate indications for use or

- Received doses exceeding maximum recommended dosage levels including duplicative therapy"

(4.)  The Minneapolis Star-Tribune recently ran a story much like the St. Petersburg Times story. The article appeared in the March 9th, 2008 issue of the Star-Tribune. "People with dementia getting drugged rather than helped." The following is quoted from this article:

"using powerful antipsychotic drugs to quiet disruptive people with dementia – at times a step that's easier and cheaper than taking staff time to fix the problem. The practice is alarming Medicaid officials enough that last year they ordered stare nursing home inspectors to start cracking down on it.

Of the state's 398 nursing homes, 38 percent were cited last year for using such medications inappropriately, up from 27 percent in 2006. So dangerous are the drugs that the Food and Drug Administration requires some to carry a "black box warning" that they heighten risk of death for older patients, a warning that might extend to all antipsychotic drugs. They also increase the risk of confusion and falling.

Dr. Robert Sonntag stated: "You don't use antipsychotics just for Alzheimer's and you never, ever drug a patient to just make life easier for the staff or the family." 

Note: One of the drugs described in the above articles is "Seroquel". This is the antipsychotic drug that my mother Ellen F. (Nedland) Silbaugh was on when she died suddenly. My mother was an elderly Alzheimer's patient in a small town nursing home in Barron, Wisconsin. My mother died of one of the two causes associated with the use of Seroquel. My mother who had never had a heart condition, and had the blood pressure of a teenager, died suddenly of a heart attack. There is no question in my mind but that a negligent medical establishment caused my mother's early death.

(Photo below right is my mother Ellen F. (Nedland) Silbaugh taken in 1994 before her Alzheimer's.)

(5.)   The Wall Street Journal in their "Technology & Health Section for Friday January 9, 2009 has a story by Shirley S. Wang entitled: "Antipsychotics Can Spur Alzheimer's Deaths."

This story reports the results of a clinical trial in the UK and documented in the British Medical Journal Lancet Neurology. These findings support the previous indications of doubling the mortality of Azlheimer's patients who are placed on the antipsychotic drugs as described above. 

 "The long term use of antipsychotic medications in patients with Alzheimer's disease appears to nearly double their rate of death after one year. ...."Patients who remained on antipsychotic drugs were significantly more likely to die after one year or longer than those who were swithched to a placebo."....After three years, patients in the placebo group had a two thirds chance of still being alive while those in the antipsychotic treatment gorup had only on third chance..." 

(6.)  The AMDA publication (Official publication of the Medical Directors Association) "Caring for the Ages" discusses medication problems with the elderly in almost every issue. The October 2007 issue has an article "The Challenge of Cutting Medications in LTC." It discusses the use of "Atypical Antipsychotics" as used on my mother the article concludes: "The relative risk of death goes up and the chance that you are going to help the patient is small."

Literally every issue of the AMDA publication referenced above decry's the dismal practice of using off label atypical antipsychotics for behavior problems of the elderly and dementia symptom residents. In fact the January 2008 issue has three such articles. The front page article starts out telling how such use is effective less than 20% of the time. The second article same issue talks about the use benefit as being "uncertain, even dangerous." The third article refers to "unapproved medicines whose harm can outweigh their benefits", etc. etc.

My mother exhibited additional signs and symptoms of an ADR (adverse drug reaction) called Tardive Dyskinesia that is associated with the use of Seroquel and other antipsychotics. (Abnormal involuntary movements of the jaw. Repetitive chewing motions or movements.) It is a muscular disorder. These motions were almost continuous over a period of a few months. My inquiry of the nursing home staff revealed no answers as to the cause. It is when I researched Seroquel (post mortem) that I found the answer. It was not something that my mother would do on occasion but was almost continuous while awake. This should have been a wake up call for the entire medical staff. The Alzheimer's Society in March 2004 had the following to say about this ADR associated with antipsychotic drugs. "Tardive Dyskinesia, which is recognized by persistent involuntary chewing movements...This may be irreversible, but is more likely to disappear if it is recognized early and the medication causing the problem stopped."

* emphasis added.

Below is a copy of the actual FDA Black Box warning that is packaged with every prescription of Seroquel. This warning was first issued by the FDA on April 11th, 2005 as an FDA Public Health Advisory. Similar FDA Black Box warnings are used with all of the other antipsychotic drugs mentioned above!.

(7.)  The latest and by far the largest study of the use of antipsychotics by the medical profession was just reported in the Wall Street Journal on January 15th, 2008 under the title of "Study Confirms Antipsychotics Pose Heart Risk." The article by Robert Tomsho states: "Patients taking the latest generation of antipsychotic drugs are twice as likely to suffer sudden cardiac failure and death as nonusers, according to a new study that found such medicines are no safer than the older ones.....the study...was one of the largest to date, and it found dangers for younger adults, too."

The study was just released in the New England Journal of Medicine. "researchers at Vanderbilt University in Nashville, Tenn. reviewed the medical records of about 277,000 Tennessee Medicaid enrollees for the years 1990 to 2005. Of them, about 46,000 were taking atypical antipsychotic drugs and 44,000 were taking typical  antipsychotic drugs. Patients ranged in aged from 30 to 74 years; the average age was about 46.

The death rate from cardiac arrest were double the rate for the antipsychotic drug users compared to the non users. (The atypical drugs in the study  were Seroquel, Zyprexa, Risperdal and Clozaril. The typical antipsychotic drugs used for comparison were Haloperidol and Thioridazine.

An editorial accompany the new study said the use of such drugs should be "reduced sharply" among children and elderly patients.

(Connecticut, Arkansas and other states were reported to have sued various drug makers, alleging that they marketed such drugs for uses not authorized by the FDA and didn't adequately disclose potential side effects...)

This study is a further condemnation and indictment of the medical profession and it's many  doctors who go their own way for the sake of expediency and convenience. This danger has been well known since 2005 and ignored by doctors and the medical profession. The sale of antipsychotic drugs in the US has increased EVERY year since 2003 including 2008.

(8.)  Article in the Minneapolis Star-Tribune (Ira Rosofsky - Psychologist) 27 March 2009 entitled: "Enough With The Drugging of Old People." Sub title reads: "We spend billions on this practice. Does it make living with dementia any easier? for us, maybe, Not for them."

"A survey released in 2002  by the Kaiser Foundation found that the staffs in a typical nursing home spend about two hours and 20 minutes a day with each resident. For the remaining 21 hours and 40 minutes, residents are left to their own (mostly medicated) devices. Where is the comfort in that? Dementia sufferers in nursing homes are not only taking donepezil and memantine but other similarly questionable drugs for depression, anxiety, psychosis or simply being ornery. It is easier to medicate than to engage. And when the chemical restraints don't work, nursing homes use physical restraints...why not admit the failure of medication and instead spend some of that money on more staff to hold the hands of both patients and their families?" Beyond nurturance, the savings could be deiverted to research that might yield not only statistically significant but meaninful and large improvements. Or maybe even a cure."

(9.)  Article in the AMDA "Caring For The Ages", June 2009 issue verifies that the use of antispsychotic's for behavioral problems continues to be used in large amounts and continues to be a failure. When will doctors discontinue this outrageous practice and conduct. FDA's warnings and lack of approval seems to fall on deaf ears. "Residents of 670 nursing facilities in New York state were studied. All had a...diagnosis of dementia or Alzheimer's disease...One third of the residents with dementia was taking an antipsychotic at  admission and most continued to do so for nearly a year. Another 16% were started on an antipsychotic within 3-6 months of admission, and nearly half of these patients continued on the meds of up to a year. Overall, the average time on antispychotic therapy was 15 months...Residents receiving antipsychotics at the time of admission and then removed frm the meds showed the greatest improvment in behaviors...The researchers also found that residents taking antipsychotics were 24% more likely to fall and more likely to experience functional decline over time than those not taking antipsychotics...Speaking of leaders at one facility..."They were worried that if they took everyone off these meds they'd go crazy. Instead, people actually came alive. They were more alert and more commuicative."

(10.) Article in AMDA "Caring for the Ages" November 2009 has an article on "Sublingual Antipsychotic Coming to Market". This discusses a new FDA approved drug in August 2009. The drug is Asenapine marketed as Saphris by Schering-Plough Corp. (An atypical antipsychotic for bipolar I disorder and schizophrenia in adults.) The Editor's Note in this article however contains the following clarification on usage.

"Risperidone, Aripiprazole, and Rolanzapine are all currently available orally dispersing tablet formulations of atypical antipsychotics that exist in regular oral forms. Atypical antipsychotics Ziprasidone and Paliperidone are at our disposal, as well as Clozapine and a host of traditional antipsychotics. These drugs carry significant risks, especially in our LTC population and none is indicated for dementia with agitation. This new drug may be welcome but probably will have limited use in LTC.- Karl Steinberg, MD, CMD, Editor in Chief." 

(11.) Article in the AMDA "Caring For The Ages" , December 2009 issue ("Overused Antipshycotics Remain an LTC Challenge") cites evidence that the improper doctor's use of Antipsychotic drugs continues at a high level but with a few areas reporting success in elininating their use. They reference a recent article in the Chicago Tribune headlined: "Nursing Home Doctors Untouched Even as Facilities Are Cited."..."nursing home inspection reports found 1,200 violations concerning psychotropic drugs in Illinois since 2001...physicians have been prescribing the powerful medications inappropriately and without retribution."  "AMDA past president Dr. David Smith was quoted:;"when he refused to prescribe an antipsychotic that staff at an nursing facility wanted for a combative resident...the family changed to another physcian who would write the prescription. The resident became a Zombie, and they considered that an improvement."  ...Dr. Smith also stressed that many behaviors in residents, although they can be odd, are not harmful and don't call for medications." Research by a  Dr. Teigland found that "residents in for profit facilities were 20% more likely to be on antipsychotics." There are a number of vacilities nationwide that are sucessfullly reducing antipsychotic drug use...one such example is Finger Lakes Center for Living in Auburn, N.Y. "After a year, the facility celebrated the elimination of antipsychotic use for all dementia patients."

(12.) Doctors in the United Kingdom also deplore the use of antipsychotic drugs in Alzheimer's and other dementia treatments. The British "Sky News" TV Channel reported (Thursday January 8, 2009) "Drugs Prescribed to Thousands of Alzheimer's Suffers could Double their risk of Dying, Scientists have Warned." The story by correpondent Thomas Moore continued:

"New research shows antipsychotic drugs, which are used to control aggression and behavioural problems are linked to significantly higher death rates...Researchers at King's College London monitored 128 patients who were prescribed antipsychotic drugs or dummy placebo pills...after three years the difference between the groups was dramatic, with twice as many people dying in those given the antipsychotic medication."

 "Too often these dangerous drugs are used as a substitute for good quality dementia care" is a quote from the British Alzheimer's Society, Neil Hunt - Chief Executive. "The drugs increase the risk of stroke, as well as causing unpleasant side effects such as sedation." "This distressing new evidence highlights the desperate need to stop people with dementia being over prescribed antipsychotics," he said. The Alzheimer's Society believes up to 105,000 patients are being inappropriately prescribed antipsychotics.

(13.) AMDA's publication, "Caring for the Ages" April 2010, has an interesting article on efforts to reduce the use of Antipsychotic Drugs in Nursing homes - "Teamwork Can Reduce Psychoactive Drugs." by Sherry Boschert. "Using interdisciplinary teams in a systematic way can help nursing homes...stop excessive use of psychoactive medications in residents."...this came from information reported at the "Long Term Care Medicine - 2010, AMDA's annual symposium. They referenced Federal Health Regulations for Long Term Care Facilities rule 329 (F-Tag 329) which mandates that "each resident's medication regimen must be free from unnecessary drugs"..."At a 230 bed long term care facility in San Antonio, an interdisciplinary team approach reduced antipsychotic use by 74%, anxiolytic use by 23% and stimulant use by 13% within 6 months"...At a 150 bed skilled nursing facility in Hendersonville, NC, 6 months of an interdisciplinary team approach reduced use of antipsychotics by 54%, reduced the use of hypnotics more than twice a week by 64% and decreased psychiatric discharges to hospitals by 72%"...The incidence of untreated depression dropped by 47% and the proportion of residents experiencing increased symptoms of depression or anxiety fell by 10%. Rates of pressure ulcers declined by 66%, falls...reduced by 25%."

Stan Berg updated (5/05/2010)