Share this pageFDA Approved Drugs
- Details
- Published on Tuesday, 27 May 2008 17:55
- Written by Stanton O. Berg
---
Note: (11 June 2021) the FDA Approved a new Drug "BIOGEN" said to be the first one Approved in 18 Years, is in Stan's Opinion No better than the current Five Approved Drugs, which have little value and could best be described as "Worthless!...see below BREAKING NEWS "6/11/2021."
-
"A third member of a panel of outside advisors to the U. S. Food and Drug Administration has resigned in protest over the Agency's decision to approve BIOGEN INC's Alzheimer's disease treatment despite the committee's recommendation against doing so."
-
"Aaron Kesselheim a professor of medicine at Harvard Medical School who had served in the FDA's Advisory Committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel."
-
-
Note: I do not make specific or individual recommendations on treatments nor drug usage in any specific case. If you find the contents of this page applicable to your situation or your loved ones situation, make your decision based on a discussion with your own doctor or a competent doctor in the field of Geriatrics and Internal Medicine!
---
At the present time the FDA has approved five (5) drugs for the treatment of Alzheimer's Dementia symptoms.
No drugs are approved for behavioral, antidepressant or psychiatric symptoms for Alzheimer's Dementia treatments.
The Alzheimer's treatment drugs are:
(1.) Donepezil, (Aricept,
(2.) Galantamine (Reminyl)
(3.) Rivastigmine (Exelon)
(4.) Tacrine (Cognex)
(5.) Memantine (Namenda)
The first four are called Cholinesterase inhibitors while Memantine is an NMDA receptor antagonist. The two types of drugs work in different ways in attempting to manage symptoms. The cholinesterase inhibitors are said to help boost the levels of a brain chemical called acetylcholine. Memantine (Namenda) is said to counteract abnormal brain activity caused by another chemical called glutamate.
---
The AMDA publication (Official publication of the Medical Directors Association) "Caring for the Ages" recently discussed the present drugs available for treatment of Alzheimer's patients and their relative effectiveness. The following is quoted from an article by Michele G. Sullivan in the April 2008 issue. "Panel Notes Modest Dementia – Drug Effects."
Clinical Guidelines
(Ann. Intern. Med. 2008; 148:370-8)
"Cholinesterase inhibitors and NMDA-receptor antagonists are not one size fits all drugs for patients with dementia, according to a new set of clinical guidelines."
"These drugs can only alleviate symptoms and may slightly delay progression," said Dr. Amir Qaseem, author of the guidelines and a member of the Joint American College of Physicians/American Academy of Family Physicians Panel on Dementia.
"They should not be prescribed to every dementia patient because the benefits are very modest and some patients may not show benefit at all, and all the drugs carry potential harms."
"Although studies find that many patients do show improvements while taking the drugs, most of those changes are small and not clinically meaningful, according to the guidelines (Ann. Intern. Med. 2008; 148:370-8). The panel also concluded that there is insufficient evidence to recommend one drug over another for the treatment of dementia. Instead, "the choice of therapy should be based on evaluation of adverse events, tolerability, and cost," Dr. Qaseem said in an interview."
"The panel found only (3) three high quality head to head trials. Two pitted Donepezil against Galantamine. One 52 week study showed no significant difference in primary outcome or function. The other an 8 week trial favored Galantamine for cognition. The third trial compared Donepezil with Rivastigmine over 2 years. Patients taking Rivastigmine fared significantly better in function and some measures of behavior but experienced more adverse events."
Editorial note: These guidelines are less than a ringing endorsement for the use of the drugs. June's experience would support these guidelines.
Aricept Patent expired November 25th 2010!
---
The U.S. News and World Report in an article: "Are Americans Taking Too Many Drugs" October 2010 reports on an ARICEPT comment by Dr. John Morley. Morely is the director of geriatric medicine at the St. Louis VA Medical Center...he is reported as saying "Doctors sometimes suspend common sense when prescribing a treatment plan. "For Example, they prescribe ARICEPT for Alzheimer's patients and then treat a frequent side effect, urinary incontinence, with anticholinergic (an inhibitor of nerves responsible for involuntary movement) like Enablex or Ditropan whose side effects include delirium, confusion, and memory loss."
---
British Government Study of Aricept - 25 June 2004 - New York Times
British Government Study on Aricept. (Published in the New York Times June 25th, 2004.). "The study paid for by Britain's National Health Service was the only large one to be done independent of the drug industry."
"The most widely prescribed drug for Alzheimer's disease, Aricept, does not delay the onset of disability or the need for a nursing home, British researchers are reporting today..... The researchers say that the drug has "disappointingly little overall benefit" and is "not cost effective, and that better treatments are needed."
"The new report, being published in today's issue of the Lancet, the British medical journal, is based on a study of 565 patients with mild to moderate Alzheimer's disease who were assigned at random to receive either Aricept or a placebo and were then followed for up to three years.....Although the patients taking the drug did have slightly higher scores on mental tests, after three years they did not differ from the placebo group in their rates of being put in a nursing home or becoming disabled......There were also no significant differences between the groups in behavioral or psychological symptoms or in the emotional well being of the people taking care of the patients.
Richard Gray, the director of the study and a professor of medical statistics at the University of "Birmingham, in England, said in a telephone interview that Aricept offered "poor value for the money," "with such small benefits that patients and families would probably not notice a difference if they discontinued the drug."
Dr. Sam Gandy, director of the Farber Institute of Neurosciences at Thomas Jefferson University in Philadelphia, said "These are very clear results. They're not marginal results. And it's a large, long, well designed, well controlled study."
"Earlier studies sponsored by drug companies and used in advertising campaigns had suggested that Aricept could delay a move to a nursing home by several years. Professor Gray's findings make those claims implausible, according to an editorial in the Lancet by Dr. Lon S. Schneider, director of the Alzheimer's research Center of California at the University of Southern California."
"The belief that patients who quite the drug would "crash" mentally was widespread, Dr. Schneider said, but he called the idea a marketing claim and said the study refuted it."
---
University of Oxford review/study found only small improvements from by use of Alzheimer’s Drugs - 5 February 2006. Drugs Aricept, Exelon and Reminyl (Galantamine) were compared.
Review author is Jacqueline Birks of the University of Oxford. Birks’ review included 13 high-quality studies involving 7,298 patients from North America, Europe and Australia. The studies compared the three drugs against placebo treatment, with 2,228 patients in the Aricept studies, 2,267 in the Reminyl (Galantamine) and 2,803 in the Exelon studies.
“The effects of the drugs were not very large when measured across the 13 studies.”…”patients across the studies improved by an average of less than 3 points on a 70 point scale that tracks mental functioning.”
These results were described as “Modest Improvements” in one comment and “small improvements in mental functioning and ability to carry out everyday activities” in another comment.
Note: The 3 point difference represents only about a 4% improvement…while this may have statistical significance I doubt that very few medical people would consider this to have any practical or clinical significance. The three drugs were found to be “equally effective.” I would think a better description would be that the drugs were “equally ineffective.”
“Side effects caused about 29 percent of the patients taking the drugs to leave the studies...” (Most common side effects were nausea, vomiting and diarrhea.)
---
Aricept and Nightmares.
Although nightmares are not listed as a side effect of Aricept by the drug manufacturer, they have been frequently reported as a side effect by users and particularly when taken in the evening. Two scientific papers (1998 and 2004), studies and other references also document this side effect. The Alzheimer's Association Online Community has a number of such reports recorded!
1. November 2004 - British Journal of Clinical Pharmacology - Jackson, Ham and Wilkinson. "Insomnia and other sleep disorders (Abnormal Dreams, Vivid Dreams and Nightmares) have been reported following the administration of donepezil". Three double blind studies involving 468, 818 and 1920 Alzheimer's patients. 18%, 8% and 9% insomnia and abnormal dreams reported for the three trial groups. "Donepezil, particularly when administered in the evening...When insomnia or abnormal dreams occur in donepezil treated patients, switching to morning dosing may eliminate these events."
2. January 1998 - Journal of American Geriatric Society - Ross and Haim. "Aricept-Induced Nightmares in Alzheimer's disease: 2 Case Reports."
3. 2008-2011 Copywrite - Caring Inc. - Caring.Com Community. "Does Aricept Cause Nightmares?" - "Even though nightmares are not listed as a side effect of Aricept many people do have this side effect and it increases as the dosage of this medication goes up. Most of the people that have this effect say that the side effect and the vivid dreams go away when the Aricept is discontinued."...
4. 22 December 2008 - John Hopkins Health Alert - "Vivid dreams and nightmares can be side effects of all the cholinesterase inhibitors, the drug class in which Aricept, Razadyne and Exelon reside. The can also be side effects of most antidepressant medications, especially those in the selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) classes....have found that lowering the dosage sometimes helps."
5. February 2006 - October 2010 - Alzheimer's Association Online Community - Message Boards - Aricept and Nightmares - Topic" This topic drew numerous responses of Nightmares by message board members who were on Aricept or by a family member on Aricept as reported by a caregiver or other family member. There were (16) sixteen responses during this time period referencing "Nightmares, and Vivid Dreams" in connection with the usage of Aricept. (One referenced an anti-depressant) Sample comments: "My mother has Nightmares", "My husband...nightmares", "My Dad has been having horrible Dreams", "My husband vivid dreams and nightmares", "Vivid and strange dreams", "I had some nightmare whoppers", "produced terrible nightmares", "they gave me bad dreams", "suffered the nightmares", "Vivid dreams...becoming more disruptive", "The nightmares/bizarre dreams"...
6. 21 August 2011 - WebMD - Reports that an infrequent side effect of oral Aricept is severe Nightmares.
Note: The Wellness Net reports (February 2012) "Sleep disturbances, including vivid dreams are an unusual (<5%) but recognized complication of cholinesterase inhibitor therapy. Aricept, Cognex, and Exelon are all members of this drug class."
---
Namenda Update: (3 March 2009) The Wall Street Journal
The Wall Street Journal Reported in their Health Section (3 March 2009) "Drug Cocktail May Slow Azlheimer's".The article describes two recent studies. "While there's no cure, some doctors say a two drug cocktail including memantine (Namenda) is the best way to slow deterioration in quality of life. (Studies from Harvard University -382 patient study and University of Pittsburgh 942 patient study.) The 943 patient study "found that patients getting combination therapy were a third less likely than those taking cholinesterase inhibitors alone to be admitted to a nursing home during the average follow up time of five years." The 382 patient Harvard study reports "slowed decline in daily-life activities and cognitive function...than patients who go a cholinesterase inhibitor alone." June's experience reported below does not support these conclusions.
---
Aricept - Namenda Update: Minneapolis Star-Tribune 27 March 2009
Star Tribune 27 March 2009 contains an article by a psychologist (Ira Rosofsky) who feels there is little value to any drugs prescribed as therapy for Alzheimer's and other dementia victims.Article title is: "Enough with the Drugging of Old People." The sub title states: "We spend billions on this practice. Does it make living with dementia any easier? for us, maybe, Not for them." He talks of how the nation's policymakers need to begin "ending the over dependence on drugs in treating dementia.". He states: "As a psychologist who works in nursing homes, I am intimately aware of the large numbers of residents who take one of both of two FDA-approved drugs for dementia - known generically as donepezil and memantine, or by the brand names of Aricept and Namenda. I am also aware of the huge and growing expenditures for these medications - close to 3 billion annually worldwide for Aricpet and more than $500 million for Namenda. Big Pharma spends as many billions of dollars on promotion as it does on research and development. Examine the documents supporting the FDA's approval of Aricept and you will see upon what a slim reed this drug's empire was built. Those taking the drug scored, on average, three points better on a 70 item cognitive assessment scale. That's about a 4 percent difference...At best, these drugs may be only marginally more effective against dementia than garlic was against the Black Death in the 14th century. Could the billions spent annually be better directed?...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 diverted to research that might yield not only statistically significant but meaningful and large improvements. Or maybe even a cure."
---
Memantine (Namenda) update – 11 April 2011 – “Archives of Neurology”
Research headed by lead researcher Dr. Lon S. Schneider, professor of psychiatry, neurology and gerontology at the University of Southern California Keck School of Medicine is reported on in the Archives of Neurology.
Schneider’s team conducted a meta-analysis by pooling and analyzing the results of published studies. Three trials were identified that included a total of 431 patients with mild Alzheimer’s disease and 697 patients with moderate Alzheimer’s disease. When looking at each study individually or pooling the data from the three studies, they found no significant difference between people with mild Alzheimer’s disease taking Memantine or a placebo.
Further, the authors concluded that evidence for the effectiveness of Memantine in patients with moderate Alzheimer’s disease was “meager”. “Unfortunately, this new study demonstrates that the average response with mild to moderate Alzheimer’s disease is marginal at best.”
---
June's Experience with Aricept
June started taking Aricept in August of 1998. This was just a few months after her diagnosis of early stage Alzheimer's in January. June continued taking this drug up until November 2004. (6+ years.) Her dosage was 5 mg's twice a day - Total of 10 mg's a day. I was never able to determine if Aricept was actually helping June either by improving her cognitive symptoms or slowing the progression of the disease
( Photo below right is June Berg in February 1998, at San Francisco, CA. June had just been diagnosed with Alzheimer's in January.)
I thought June was tolerating the drug well but as I found out later, that assumption was incorrect. I was afraid to take her off of the drug in the event it was helping her. The decision to remove June from Aricept came as a result of a recommendation by a Dr. at the University of Minnesota's Oral-facial Pain Clinic. Shortly after June started taking Aricept, she developed facial pain along the left side of her nose and on up to her forehead. At times it seemed to center itself over her teeth. The pain seemed to be intermittent and varied in intensity and at times caused June much distress. Because of the symptoms no one associated it with the use of Aricept. June was seen by two different EENT specialists, the Fairview Pain Management Center and finally by the University of Minnesota Oral-facial Pain Clinic. The university gradually ruled out all the various possibilities and finally centered on the Aricept. Such pain is not listed anywhere as a side effect to that drug. Immediately after June discontinued the Aricept, the pain went away forever.
Note: I have gult pangs every time I think of June and the years of pain she went through due to Aricept. All due to my ignorance and the ignorance of the medical profession. June trusted me to take care of her and I blew it big time!
---
June’s Experience with Namenda
This drug was approved by the FDA in October 2003 for the treatment of moderate to severe Alzheimer’s disease. It was the first such drug approved by the FDA for this level of severity of the disease. (This drug was actually developed 20 years earlier in Germany and was already in common use throughout Europe.)
(Photo below right taken of June at the Wellstead in November 2005 - Approx. Seven years and 10 months following her diagnosis. June has a faded appearance. Her large signature smile is replaced with a weak one. Currently June has no smile - May 2008.)
June was started on the drug on 10 March 2004. She began a dosage of 5 mgs that was increased in 5 mgs increments weekly until the target dosage of 20 mgs was achieved. (10 mgs twice daily) June seemed to tolerate the drug without any apparent side effects. June continued on this drug until it was gradually phased out and discontinued 4/6/2006. (2 plus years.) It was gradually discontinued after June’s Alzheimer’s had progressed to the late stages of the disease and June was then in Hospice Care. There appeared to be no reason for June to continue with the drug. I was never able to note either temporary cognitive benefits from the use of this drug or any apparent slowing in the progress of the disease. Her progression of the disease actually slowed down more after she was removed from this drug and all such drugs..
Note: There were a few months of overlapping coverage in the usage of both Aricept and Namenda. (March to November 2004.) No apparent benefit could be noted in June's usage of this drug or the combination usage of Namenda and Aricept.
---
June's Experience with Depakote: (Divalproex Sodium, Valproate, Valproic Acid.)
This drug was approved by the FDA primarily to treat seizures and convulsive disorders. It was also being studied as a treatment for Alzheimer's. Some initial research indicated that it had value for such treatment.
June had 4 seizures during her journey through Alzheimer's. the first two seizures took place a month apart in mid 2005. 5/2/2005 and 6/2005. The third seizure took place on July 4th 2006. The last seizure described as a mild one took place in mid year 2008.
I requested that June be placed on an anti-convulsive drug immediately after the first seizure. I pointed out that seizures while they were not considered an everyday Alzheimer's symptom they were not uncommon with this disease. (June had been taken to the nearby hospital emergency room to check out possible brain tumors etc.) Based on the opinion of the emergency room doctor, the first seizure was not taken seriously and was thought to be an anomaly not a part of the Alzheimer's disease. I did not agree but having no medical credentials, my opinion was ignored. When a second seizure took place a month later, June was immediately placed on Depakote.
June was started on an initial dosage of 250 mgs of Depakote. In order to reach what was considered to be a "Therapeutic level" (50-100 mcg/ml) in the blood stream, June was given gradually increased dosages by increments of 125 mgs until she was receiving 625 mgs per day. This 625 mgs daily dosage was then continued until June passed away on October 23rd, 2008.
This medication appeared to be very effective in preventing seizures. The first seizure following the prescription of Depakote was just over a year later on July 4th 2006. It was my thought that there had been a breakdown on the administration of the medication that caused the July 4th seizure. June due to her advanced Alzheimer's was difficult to feed and administer medications. Not all LPN's assigned with this function were adept to doing so. It was usually mixed with other foods to facilitate the administration. Some of the medication is always lost in this procedure. It is also my thought that this may have been the cause of the mild seizure in 2008. Sometimes there are errors in medication administration. I recall on one occasion when a new duty LPN had administered the morning medication with an improper dosage. I happened to be there at the time, and I suspected that there had been an error. When I questioned the LPN about it, I found she had administered a single pill of 125 mgs instead of 5 - 125 mg pills to give the proper dosage of 625 mgs. If I had not been there to double check, the error would have gone unnoticed.
Research Notes: The initial thoughts of Depakote being of assistance in Alzheimer's treatment has proven to be false and in fact it appears to have a negative result in this regard. The AMDA publication "Caring for the Ages" in the October 2009 issue states: ("Failed Drug Trials Suggest Alzheimer's Shift) "Divalproex treatment over 2 years didn't delay the onset of agitation or psychosis in patients with Alzheimer's disease, and patients taking the anti-convulsant showed significantly more brain volume loss on MRI at year 1 than did those taking the placebo."
The same article states: "Combo No Better Than One Drug." - "A combination of two drugs already proven effective in Alzheimer's disease worked no better than a single agent to slow the disorder's cognitive and functional decline. (Galantamine and Memantine compared to Galantamine alone in 233 patients.)"
The AMDA publication "Caring for the Ages" in the June 2010 issue contains alarming information on Depakote under the title of "Anti-convulsant Risk Suggested in Dementia." A study by Doctors Kales and Zivin of the University of Michigan and the Veterans Administration Healthcare System in Ann Arbor reported that in a study of antipsychotics usage and Valproate usage (looked at national data from 254,564 Department of Veterans Affairs outpatients with dementia) and found that not only was "Haloperidol associated with higher mortality than the atypicals" but in addition..."What was unexpected was the finding that Valproate was associated with higher mortality than all of the antipsychotics, including Haloperidol."
---
Antipsychotic Drugs
Please note that NO antipsychotic drugs are approved for use in treatment of Alzheimer’s or other dementia type diseases…these are very dangerous drugs and usually increase the mortality rate by double…they also have very dangerous side effects…their use should be considered only as a last resort and only with great caution and care and after consultation with competent medical doctors in the field…Below is an in depth discussion of the subject from June’s web site and reflects current thought in this area…
---
Reader's Comments
Deb Adz McMum McEvoy-McBrias - Liverpool, United Kingdom - (7 March 2015): "Hi I've just been reading Junes website. It's got so much info in it. I was very interested in the Aricept part of her medication. My mum was prescribed this drug only last week. Today we have decided not to go down the Aricept path Only time will tell us if we were right or wrong. You should be so proud of yourself creating Junes website. Am sure she must be so proud of you. Take care."
Lisa Smith - Rochdale, United Kingdom - (14 September 2015):"Thanks for posting this Stanton I've had a quick read and found this very helpful . I've been told by doctors there is no medications for such conditions only to treat symptoms. Obviously not...I knew I was right regarding antipsychotics and this confirmed it..."
---
After battling Alzheimer's for almost 12 years, an exhausted June was finally called home by God on October 23rd, 2008. Her funeral notice as published in the Minneapolis Star in October 2008 can be seen on this website under the "In Memoriam" label - or just click on:
"June K. (Rolstad) Berg - In Memoriam".
---
For the story of June’s favorite home at 6025 Gardena Lane and the poem I wrote about this home during a day of deep sadness, click on the below link: (This was June’s home for almost 40 years. It was constructed shortly after the previous home was severely damaged in a tornado. 6025 Gardena Lane was the first home the June participated in the selection and purchase of a lot on a small hill, helped with the design of the home and watched it being constructed. 6025 Gardena Lane had a special place in her heart.)
“6025 Gardena Lane – June’s Favorite Home”