My mom is in an early stage 5 I would say and has recently begun to have agitation and combativeness towards my father from around 7-11pm. This is sundowning I suppose. Anyway, my father is critically ill himself and this arguing every night is just about to get the best of him. My mom's GP put her on Risperadol (I don't remember the dosage, as I haven't even picked up the prescription yet) and I'm leery about giving it to her after reading some terrible things about it. Any suggestions? And what about this melatonin I've been reading about? Is that a prescription or a natural remedy found in health food stores?
Any advice would greatly be appreciated!

Kanga---Sundowning is something that I have no experience with...so...I also lack experience with Risperadol and Melatonin.

After reading the Melatonin Stops Sundowning and Aggression thread started by Pat M and getting to know her, I already obtained permission from Charlie's GP to administer 6 MG of Melatonin 30 minutes before his bedtime should problems begin.

Melatonin is inexpensive and considered a supplement. It is widely available in both drug and health food stores. It is frequently given to autistic children to regulate their sleep patterns and about the only negative thing that I have heard about it is that it tends to cause a lowering of the morning blood sugar level. (Since Charlie is not diabetic, this would not be a problem.)

Some of the posters on the Melatonin for Sundowning thread have experienced success and others have not. From what I understand... Melatonin may take as long as 2 to 3 weeks to kick in.

I brought the thread to the top for you.

Should you decide to give it a try please check with your mother's GP before starting it and post your results on the Melatonin for Sundowning thread.

Good luck.

Kanga, see information on melatonin from the Alzheimer's Research Forum:

http://www.alzforum.org/dis/tre/drc/detail.asp?id=52

http://www.alzforum.org/new/detail.asp?id=932

http://www.alzforum.org/pap/an...tion.asp?powID=33037

http://www.alzforum.org/new/detail.asp?id=1846


Note that the last one indicates that light therapy may be helpful by itself, or improve any benefits that might be found from melatonin.

JAB,

Thank you for listing those links. I'm very skeptical of over-the-counter supplements, herbs, etc that are regulated by the FDA. As the daughter of a pharmascist, I've picked up bits and pieces of knowledge over the years. Also, AD is a very tricky disease. For example, sleeping pills and tranquilizers act differently with AD patients than with a healthy person.

kanga1,

I'm living through the sundowning nightmare with my mother, the pharmacist, right now. It's very difficult for this 53 yo healthy person. I can't imagine how an ill, elderly gentleman could possilby cope with it.

In my opinion, trust your doctor, try the Risperadol or get a new doctor. The doctor is much more able to interpret the information from drug companies about the medications they manufacture (unless you are a medical researcher). The contraindications on Seroquel says not to give to people with dementia. That gave me pause, but the benefits have been 100% while any problems are probably less than a fraction of a percent. The drug companies have to include this info in their brochures to protect themselves legally. We have the FDA for a reason. Sorry for my rant.

Also, remember that your mother's sundowning is also having a detrimental effect on your father's health as well.

I did not like my mom taking risperadol. I found it made her worse. Then they used haldoral it calmed her down. Drugs didnt really work. Try to find natural ways that might work.

Hi, Daughter. It can indeed sometimes be difficult to find a med that helps a particular patient with behavioral problems. Some patients respond very well to Risperadol, some don't do well on that but do respond to Seroquel, Abilify, or Geodon, etc.

There are a couple of good articles on the medicines that are commonly used to treat AD patients who develop behavioral problems at:

http://alzheimers.boomja.com/T...-Symptoms-48701.html

An estimated 64,000 Alzheimer's and dementia patients are murdered each year by the drug Risperdal and other antipsychotics that have Black Box Warnings on them...NOT APPROVED for use on this population. I think this number is probably much higher since a good number of the deaths are from stroke or cardiac arrest and their family members would never suspect a drug was behind it.
Please go to www.lakelandtimes.com and enter Risperdal in the Search box. Five articles should pop up on the problem nationally, in my home State Wisconsin and 38 other states, and my Dad's story. He was murdered by Risperdal on June 19th, 2008. Since then, I've been trying to bring national attention to this issue and frankly too many politicians, agencies and organizations are in bed with the big pharmaceutical companies to put a stop to this.
My little local newspaper and a wonderful reporter, Richard Moore, did an incredible job investigating this and reporting on it. I've contacted most of the major news organizations and papers and one else has frankly had the balls, to go near this. It's too bad my Dad and his fellow dementia patients didn't have Swine Flu or weren't pets being poisoned by tainted food from China. Those issues would have made national news in days. It's been almost a year since my Dad died. Richard's investigation continues.
Again go to www.lakelandtimes.com and enter the word Risperdal into the Search box.
If there is anyone out there that can help with this issue, please contact me at lmakarrall@yahoo.com.
Lisa MaKarrall 5/23/2009 10:18:51 AM

An estimated 64,000 Alzheimer's and dementia patients are murdered each year by the drug Risperdal and other antipsychotics that have Black Box Warnings on them...NOT APPROVED for use on this population. I think this number is probably much higher since a good number of the deaths are from stroke or cardiac arrest and their family members would never suspect a drug was behind it.
Please go to www.lakelandtimes.com and enter Risperdal in the Search box. Five articles should pop up on the problem nationally, in my home State Wisconsin and 38 other states, and my Dad's story. He was murdered by Risperdal on June 19th, 2008. Since then, I've been trying to bring national attention to this issue and frankly too many politicians, agencies and organizations are in bed with the big pharmaceutical companies to put a stop to this.
My little local newspaper and a wonderful reporter, Richard Moore, did an incredible job investigating this and reporting on it. I've contacted most of the major news organizations and papers and one else has frankly had the balls, to go near this. It's too bad my Dad and his fellow dementia patients didn't have Swine Flu or weren't pets being poisoned by tainted food from China. Those issues would have made national news in days. It's been almost a year since my Dad died. Richard's investigation continues.
Again go to www.lakelandtimes.com and enter the word Risperdal into the Search box.
If there is anyone out there that can help with this issue, please contact me at lmakarrall@yahoo.com.
Lisa MaKarrall 5/23/2009 10:18:51 AM

quote:

Originally posted by Leah JN:
JAB,

Thank you for listing those links. I'm very skeptical of over-the-counter supplements, herbs, etc that are regulated by the FDA. As the daughter of a pharmascist, I've picked up bits and pieces of knowledge over the years. Also, AD is a very tricky disease. For example, sleeping pills and tranquilizers act differently with AD patients than with a healthy person.

kanga1,

I'm living through the sundowning nightmare with my mother, the pharmacist, right now. It's very difficult for this 53 yo healthy person. I can't imagine how an ill, elderly gentleman could possilby cope with it.

In my opinion, trust your doctor, try the Risperadol or get a new doctor. The doctor is much more able to interpret the information from drug companies about the medications they manufacture (unless you are a medical researcher). The contraindications on Seroquel says not to give to people with dementia. That gave me pause, but the benefits have been 100% while any problems are probably less than a fraction of a percent. The drug companies have to include this info in their brochures to protect themselves legally. We have the FDA for a reason. Sorry for my rant.

Also, remember that your mother's sundowning is also having a detrimental effect on your father's health as well.

Lisa MaKarrall---Thanks for visiting and posting the link to the series of Risperdol articles. I found them informative. Especially the one at: http://www.lakelandtimes.com/m...nID=9&ArticleID=9484.

I was sorry to read about your father's fate...and...Am thankful that you shared your experience. By doing so...You may be responsible for saving the lives of others.

Please note that the FDA issued an Alert in May of 2005 that Risperdal is not APPROVED for use on dementia and Alzheimer's patients due to increased risk of death....look it up. I am shocked to see that an article originally written in January of 2005 is allowed on the Alzheimer's Library to treat symptoms. How many deaths have occurred because people have taken this outdated advice. Please go to wwwlakelandtimes.com, enter Risperdal into the Search box and read the five articles that show up there. Lisa MaKarrall

quote:

Originally posted by JAB:
Hi, Daughter. It can indeed sometimes be difficult to find a med that helps a particular patient with behavioral problems. Some patients respond very well to Risperadol, some don't do well on that but do respond to Seroquel, Abilify, or Geodon, etc.

There are a couple of good articles on the medicines that are commonly used to treat AD patients who develop behavioral problems at:

http://alzheimers.boomja.com/T...-Symptoms-48701.html

Please be aware the "Alzheimer's library" you cite is not an official site of the Alzheimer's Association, and therefore the association has no control over the content there.

Could you tell me how to get anyone at the Alzheimer's Association to pay attention to this issue? I've called and e-mailed with no response as of yet. All this talk about finding a cure, but this is allowed to go on. Where is the outrage over this? Just the fact that this practice is allowed to go on in 38 states for years after the FDA issued it's Black Box Warning that Risperdal is NOT APPROVED is a question to the Alzheimer's Association. Is everyone there ignorant of the facts or do they chose to ignore them. I'm sorry if I may sound harsh, but my Dad was tortured before his death. I want a cure as much as anyone, but why isn't anyone stepping in to prevent the deaths of thousands from drugs these helpless people are being fed?

quote:

Originally posted by Carolina Songbird:
Please be aware the "Alzheimer's library" you cite is not an official site of the Alzheimer's Association, and therefore the association has no control over the content there.

Lisa---In reading your postings as well as 2 of the newspaper articles, I was unable to reach a conclusion as to what your father’s basic problem was as well as what his prognosis would have been had he not been given Risperdal..

I don’t think that the Alz. Assoc. is ignoring you. Truth of the matter is that there are not a whole lot of interventions. Most of them present some form of risk. The beleaguered caregiver of someone with A/D must opt for the potential solution that will keep things under control and do the least amount of harm.

My loved one has been diagnosed with ‘garden variety’ Alz. If nothing gets him first...With or without Risperdal....Alz. will kill him...and...the death will not be nice. My goal is make certain that he enjoys the highest quality of life until then.

Unlike most caregivers, I have not had to deal with paranoia, psychosis, or sundowning...but...we are only 3 ½ years into our A/D journey. When (and if) I have to deal with these problems, Melatonin will be my first remedy of choice. If it does not work...I will ramp up into other remedies and opt for others (both with and without black box warnings). Your links were especially helpful because they outlined potential side effects to be on the look out for.

I wish you luck with your loved one. Yes, the Alzheimers will get him. But before he goes, I hope he has the best quality of life possible. My Dad was rigid, he couldn't swallow, speak, walk, had facial tics and a variety of other Risperdal side effects. He aspirated twice, because he couldn't swallow and both times developed pneumonia, the last time turning into the MRSA that killed him. It took me getting my Dad's medical files from the nursing home, clinic and hospital and putting the pieces of his puzzle together to find the following:
1. Risperdal is not approved for use on people with dementia or Alzheimer's because it causes all of the side effects my Dad experienced and death by aspiration pneumonia. It also causes strokes and cardiac arrest.
2. No one at the nursing home knew about the Black Box Warning on Risperdal which meant no one knew what to look for as far as side effects went. My Dad had several swallowing tests while out there all the while the people performing the tests were feeding him the medication that was causing his swallowing problems.
3. Risperdal was used as a first resort, not a last for treating his anxiety, which simple changes in his enviroment were showing to help. 4. The doctors and Physicians Assistants doing the prescribing KNEW what was causing his side effects and bouts of pneumonia...took him off it after the first bout and a couple of weeks later put him back on it until he overdosed, contracted MRSA and died.
5. Our family signed a medication consent form for Risperdal, that was from 2003. The FDA's Alert came out in 2005. Since I had been told by several of the RN's working on the Dementia Ward that the place was being blanketed with Risperdal and had been for years, that means that hundreds of families did the exact same thing.
6. The doctors involved, along with the nursing home lied, threw each other under the bus, buck passed and anything else they could do to not take any responsibility for what happened.
When the Wisconsin Dept of Health investigated what happened they found that these were Statewide problems. That's when they started covering their butts for their responsibility in this mess.
Everyone needs to read all five articles, even though the first two are a bit dry. There is a reason that 64,000 people (I believe a very low ball estimate) are allowed to be murdered a year...MONEY...billions of dollars worth of it. Politicians, doctors, agencies and organizations that are supposedly supposed to be caring for, healing, advocating for, and protecting are being paid off for their silence. Why are these drugs allowed on Medicaid preferred lists in 38 states without any restrictions? Maybe this quote from the first article, 'Risperdal, Janssen Pharmaceutica Under Fire' says it all..
"In 2007, Risperdal was the world's tenth best selling drug with $4.7 billion in sales, even though schizophrenia, bipolar disorder, and autism-related behavioral problems - the only approved treatment uses of the drug - affect less than 4 percent of the population combined, according to the National Institute of Mental Health"
In thinking about what else to quote from the article to prove people are profiting from looking the other way while this continues, I've decided just to post the first article. The second article is about Wisconsin and the rest are on what happened to my family. Richard Moore and this little hometown paper, "The Lakeland Times" continue to investigate and will be updating us on their findings. COINCIDENTALLY: The first updated article will be on the firing of the Administrator of Taylor Park, the nursing home my Dad died at. She was fired this last Tuesday, four days after the last article was printed. Since I sent all the information on what happened at the nursing home to their number two person at their Corporate Office last July 2008, she is being used as a scapegoat.
There are many people involved in this outrage, some because of money, ignorance, or just a lack of caring. Now the question is who is going to stop it?
A Lakeland Times Investigative Report

The first in a series

Janssen Pharmaceutica, a Johnson & Johnson subsidiary that manufactures Risperdal, a highly controversial antipsychotic drug approved to treat schizophrenia, bipolar disorder and irritability associated with autism in children, is facing a spate of lawsuits from states who say the pharmaceutical giant fraudulently marketed what they claim is an inherently dangerous drug.

Wisconsin is not among the protesting states, however. Here, in fact, Risperdal continues to be popular among the medical establishment, sitting on the state's list of Medicaid preferred drugs and dispensed for a broad range of both approved and nonapproved uses, The Lakeland Times has confirmed in an investigation.

To cite just one example, doctors and nursing homes in the Badger State continue to prescribe Risperdal to elderly patients with dementia, despite a four-year-old warning from the federal government that such treatment is associated with an increased risk of mortality.

Risperdal and its generic formulation is one of a group of so-called new generation atypical antipsychotic drugs - clozapine, Pfizer's Geodon and AstraZeneca's Seroquel are other preferred antipsychotics in Wisconsin -- the makers of which say are safer and more effective than older first-generation medications.

The drugs are also far more expensive, not to mention lucrative.

In 2007, Risperdal was the world's tenth best selling drug with $4.7 billion in sales, even though schizophrenia, bipolar disorder, and autism-related behavioral problems - the only approved treatment uses of the drug - affect less than 4 percent of the population combined, according to the National Institute of Mental Health.

Now a growing number of medical professionals and state officials, ranging from Pennsylvania to Texas to South Carolina, say Risperdal's success is a textbook case of pharmaceutical marketing gone wild.

These officials say few of the company claims are legitimate, that Janssen in particular rigged clinical trials to attain the results it wanted and subsequently misled the medical community as well as various state officials.

What's more, they say, not only does the drug not reduce side effects associated with older first-generation antipsychotics, it is itself associated with increased risks of Parkinson's-like symptoms and other movement disorders known as EPS, of cardiovascular disease and of the onset of diabetes.

The drug has been linked to neuroleptic malignant syndrome, a potentially fatal condition involving muscle rigidity, and tardive dyskinesia, a disorder that induces repetitive, involuntary movements such as tongue pumping, lip smacking, and rapid blinking.

What's more, a 2002 study found an increased risk of stroke among the elderly taking Risperdal. In two of four clinical trials, a higher incidence of stroke was seen among participants taking Risperdal than in those groups taking a placebo, with a stroke rate among those taking Risperdal double that of the placebo groups for all four trials averaged. The four studies included 1,200 subjects.

Health Canada and Janssen-Ortho subsequently warned Canadian physicians of a possible link between Risperdal and stroke in 2002. The federal Food & Drug Administration issued a warning in 2003.

The FDA also issued a black-box warning for Risperdal and other atypicals in 2005 after 15 out of 17 clinical trials showed increased morbidity among elderly patients with dementia after being treated with antipsychotics.

Children, too, have turned out to be a vulnerable population.

According to a November 2008 report in the New York Times, from 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, and 31 died. The deaths included a nine-year-old with attention deficit troubles; the child had a fatal stroke 12 days after beginning Risperdal, the Times reported.

The pharmaceutical companies, of course, dismiss the claims and say any risks are well labeled.

On the other hand, in a 2005 interview with USA Today, FDA whistleblower Dr. David Graham estimated that off-label use of atypical antipsychotics could cause as many as 62,000 excess deaths a year, and he said the FDA - whose drug safety oversight board he characterized as a "kangaroo court" - had known about the problem for two or three years prior to issuing its 2005 warnings.



States seek reimbursement

Meanwhile, lawsuits, both individual and state-sponsored, continue to grind on. This past February, Janssen lost one of those cases, in West Virginia, where attorney general Darrell McGraw brought the suit under the West Virginia Consumer Protection Act, citing the company for making false or misleading statements to West Virginia physicians about Risperdal and another of its products, Duragesic, a narcotic pain patch.

The attorney general's office found 4,450 violations. In particular, for Risperdal, judge Martin Gaughan ruled that the company sent out false and misleading warnings after the FDA had required drug makers to warn doctors that atypical antipsychotics were associated with an increased risk of diabetes.

"The wording of [the defendants'] November 2003 Risperdal letter was intentionally constructed to modify the FDA's warning language and mislead healthcare professionals, who rely on this information when prescribing medication for their patients," the judge wrote in his decision.

Gaughan ordered Johnson & Johnson and Janssen to pay civil penalties totaling $4.475 million for the violations.

"If the FDA has approved a drug for limited purposes and drug manufacturers, in pursuit of profit, market the drug for other purposes, it is false advertising that could put the health and lives of ordinary West Virginians at risk," McGraw said after the verdict.

Other even more serious cases are pending.

In Texas, for instance, the state's preferred drug list required doctors to prescribe atypicals rather than the older, less expensive antipsychotics - a scheme the state claims Janssen manipulated by showering policy makers with a cornucopia of gifts and trips and speaking fees.

In 2005 alone, according to the Texas Health and Human Services Commission, Texas paid for approximately 308,000 Risperdal prescriptions at a cost of $73.5 million.

In February 2007, the state of Pennsylvania sued Johnson & Johnson, Eli Lilly, and AstraZeneca to recover money paid through Medicaid and other public-health programs to purchase Zyprexa, Risperdal, and Seroquel, as well as for the costs of medical care for the people injured by those drugs.

As in the West Virginia lawsuit, the Pennsylvania case says Janssen urged doctors to prescribe the drugs for dementia and other non-FDA approved disorders.

That latter charge, if true, is patently illegal. Doctors may prescribe a drug approved for one condition for other non-approved conditions - known as off-label uses - but pharmaceutical companies are not allowed to promote the drugs for uses not listed on the drugs' labels.

Perhaps the sharpest claims made against the company's conduct, and the efficacy and safety of its product, is contained in a complaint filed May 25, 2007, by South Carolina attorney general Henry McMaster.

The case is pending, but the language of the complaint is blunt.

"Risperdal is inherently, abnormally and unreasonably dangerous," the complaint states. "The health risks and costs of Risperdal to the citizens of the State and to the State greatly outweigh any claimed utility of Risperdal. Defendants knew or should have known of the dangers inherent in the use of Risperdal, and that the public and the state would be harmed by the intended and foreseeable use of Risperdal."

The state puts the number of people injured by the drug in the hundreds, "if not thousands," and says it spends millions of dollars each year to pay the health care costs of those injured by the drug.



Laying out the allegations

South Carolina brought the action on behalf of the state Medicaid program, the South Carolina Department of Mental Health, and the South Carolina state employees health plan. Specifically, the attorney general is seeking to recover funds it spent providing medical treatment to those participants suffering from Risperdal-related illnesses and to recover funds spent in purchasing Risperdal for uses not approved by the government.

Under the federal Medicaid system, reimbursements for drug prescriptions are provided only for so-called "medically accepted indications." In addition, drug companies are deemed by states to know Medicaid regulations regarding the scope of prescription drug reimbursement, that is to say, they have a duty to prevent nonmedically accepted and nonmedically necessary prescriptions from being submitted to Medicaid for reimbursement.

Janssen Pharmaceutica, the complaint states, violated that tenet, and did so willfully.

"Upon information and belief, defendants breached this duty by knowingly causing prescriptions for nonmedically accepted and nonmedically necessary uses of Risperdal to be submitted to Medicaid for reimbursement," the complaint states.

To do so, the complaint continues, Janssen aggressively exploited a loophole in South Carolina law.

"According to the South Carolina legislature, the purpose of the Medicaid Fraud Act is to preserve the integrity of the Medicaid program by providing a statutory deterrent to any person causing submission of inappropriate claims to the program," the complaint states. "The state of South Carolina, as is true of many states, lacks a practical means of ensuring that each prescription for every drug constitutes a medically necessary use of that drug. The state thus relies on persons receiving payment and benefit to turn square corners in their dealings with the Medicaid (and other health) programs. Nevertheless, this lack of practical ability represents a loophole in the scheme of the Medicaid and other programs."

Janssen recognized and aggressively exploited that loophole in several ways, the complaint states.

"First, defendants engaged in a direct, illegal, nationwide program of promotion of the use of Risperdal for nonmedically accepted indications and nonmedically necessary uses," the document declares. "Defendants have conducted this program of promotion knowing that prescriptions for Risperdal are generally reimbursed by the state Medicaid (and other health) programs, even though prescriptions for nonmedically accepted indications and nonmedically necessary uses of Risperdal fall outside the coverage of state programs."

And it's not just the nonmedically accepted uses of Risperdal the South Carolina attorney general has a problem with; even the company's claims about its approved uses don't stand up to scrutiny, according to the complaint.

"Second, since the inception of their promotion of Risperdal, defendants have falsely represented to the state, and to the public in general, that Risperdal is safer and more effective than less expensive first-generation antipsychotics," the complaint states.

Indeed, in late 2006, both a major British government study and a United States study funded by the National Institute of Mental Health concluded that atypical antipsychotics were no safer and worked no better than the older, much cheaper generic drugs.

The American researchers pointed out that using the more expensive atypicals cost patients $300 to $600 more a month than if they took first-generation medications.



History

To understand how the states think Janssen fraudulently promoted the atypicals, and, in South Carolina's case, Risperdal, requires a little history.

The FDA approved the use of Risperdal tablets in 1993 for the management of manifestations of psychotic disorders in adults. In 1996, the FDA approved an oral solution for the same use.

In 2002, the FDA changed both indications to the "treatment of schizophrenia" in adults and, a year later, the drug was approved as either monotherapy or combination therapy for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder, or extreme mood swings.

In 2006, the drug was approved for the use in children 5-17 to treat moderate to severe behavioral problems associated with autistic disorder, though not for the core symptoms of autism.

From the beginning, Janssen touted Risperdal for its enhanced therapeutic properties without fewer side effects such as movement disorders like tardive dyskinesia. Whatever their legality and substantive merits, Janssen's promotional efforts paid off handsomely.

By 2003, atypical antipsychotics such as Risperdal had grabbed 90 percent of the market of all antipsychotic drugs prescribed for all psychiatric purposes, regardless of whether they were approved for those indications or not. Risperdal itself grabbed the largest United States market share, both for FDA-approved purposes and for unapproved purposes.

But, the South Carolina complaint alleges, that success was achieved through a series of unlawful acts and practices, including the promotion of the drug for multiple nonapproved purposes - attention deficit-hyperactivity disorder (ADHD), depression, anxiety, mood disorder, and aggression associated with late-onset dementia.



Rigging the trials, hiding the facts

The complaint argues that there have always been potentially serious side effects associated with the drug, and that the company knew it, hiding the fact by conducting fake clinical trials.

"Medical literature dating as far back as the 1950s, and defendants' own pre-clinical studies of Risperdal, demonstrated that Risperdal, like older antipsychotic medications, had the potential to cause diabetes, diabetes-related injuries (e.g., weight gain and hyperglycemia), cardiovascular complications and other severe adverse effects," the complaint states. "By the time Risperdal was first marketed, the neurochemical bases for the efficacy and side-effects were generally known to defendants, i.e., effects on dopamine, serotonin and histamine systems in the brain. Therefore, prior to marketing, defendants should have been concerned about Risperdal causing neurological problems, weight gain, diabetes, pancreatitis, hyperglycemia, cardiovascular complications and metabolic syndrome. And yet Risperdal's original label, and all label changes until 2004, did not adequately warn of these adverse side effects."

Despite all those potential side effects, the complaint alleges, Janssen opted for the bare minimum of clinical trials for the drug, and those were of limited duration, "such that no side effects were likely to be revealed."

Not only that, but those trials did not confirm the notion that Risperdal and other atypical antipsychotics were less likely to cause movement disorders and muscle rigidity.

"Upon information and belief, defendants trials were designed to produce similar rates of EPS in patients sorted into placebo groups and those taking Risperdal," the complaint alleges. "In order to produce their desired result, defendants selected patients for the placebo groups that were already in the course of treatment with high doses of typical antipsychotics."

That was important because, as the complaint pointed out, the manifestation of EPS in a patient taking antipsychotic drugs is dose dependent - the larger the dose, the more likely EPS will become, and those who develop it generally continue to experience EPS for months, even after discontinuing treatment.

Thus, the patients in the placebo group would continue to show signs of EPS at the same rate as when they were taking the antipsychotic drugs, while those taking Risperdal predictably developed EPS at the rate expected in a population taking antipsychotic drugs, a rate which essentially matched that of the placebo group, the complaint reports.

"Based on the similar levels of EPS in the placebo and Risperdal groups, defendants claimed, in their marketing, that patients taking Risperdal were as likely to develop EPS as patients taking nothing and thus less likely to develop EPS than patients taking traditional antipsychotics," the complaint states.

Janssen also knew about the drug's propensity to cause weight gain, thereby significantly increasing a patient's risk of contracting diabetes, the complaint states.

"Despite such knowledge, defendants failed to include a warning of the potential for weight gain and the possible development of diabetes as a result of the use of Risperdal in its US labeling for years," the complaint states. "In fact, defendants concealed the true safety profile of Risperdal from 1993 until 2004. Even then, defendants did not warn citizens of the state of the risk of diabetes associated with Risperdal."



Targeting the elderly

In 1999, according to the complaint, the FDA caught Janssen promoting Risperdal for the nonmedically accepted treatment of the elderly.

"In a letter to Todd McIntyre, director of Janssen's regulatory affairs department, the agency strongly disagreed with certain promotional materials that it had received as part of its monitoring and surveillance program," the complaint states. "According to the FDA, Janssen engaged in a false and misleading campaign to promote Risperdal to geriatric patients."

In those promotions, according to the complaint, Janssen claimed the drug was safe and effective for elderly patients, despite little or no data to support such a claim. The company also asserted that Risperdal had a low incidence of movement disorders, had a low incidence of sedation, and failed to warn that the use of Risperdal by healthy elderly patients created a greater potential for hepatic and renal dysfunction and cardiovascular problems.

Finally, the FDA found, Janssen marketed the drug inappropriately by representing that Risperdal was a safe and effective treatment for hostility in the elderly.

"Upon information and belief, despite studies and data that confirm the lack of efficacy and significant health and safety risks associated with the promotion of Risperdal for the elderly, defendants continue this practice," the complaint states.

Through all these years, the South Carolina complaint alleges, Janssen bolstered its "research" with support from bogus experts.

"Upon information and belief, defendants sought ghost written research and paid 'key opinion leaders' to support defendants' marketing claims," the complaint states. "These 'key opinion leaders' were nothing more than third-party consultants and researchers who were put on defendant's payroll to support and lend credibility to defendant's scientific and marketing goals."



Allegations

In all the state of South Carolina has filed eight counts against the pharmaceutical giant, including the submission of fraudulent Medicaid claims, recovery for the cost of treatment for injuries caused by Risperdal, violation of the state's Unfair Trade Practices Act, negligence, fraud and misrepresentation and unjust enrichment.

The state is seeking not only the return of Medicaid reimbursements for nonaccepted uses and not only the differential between the use of Risperdal and traditional antipsychotics, but also payments to cover the cost of treating injuries caused by the drug, and it is seeking a penalty of $5,000 per prescription written and three times the actual damages sustained by the state of South Carolina.

"At all relevant times, defendants knew, or should have known, that Risperdal was, and is, hazardous to human health," the complaint concluded. "Risperdal is abnormally and unreasonably dangerous as marketed in that the health risks and costs associated with Risperdal greatly outweigh any claimed utility of Risperdal to Medicaid (and other program) participants. As a direct result of the unreasonable marketing practices of defendants, Risperdal was, and is, defective and unreasonably dangerous."

Next: Risperdal in Wisconsin: A different story

quote:

Originally posted by skericheri:
Lisa---In reading your postings as well as 2 of the newspaper articles, I was unable to reach a conclusion as to what your father’s basic problem was as well as what his prognosis would have been had he not been given Risperdal..

I don’t think that the Alz. Assoc. is ignoring you. Truth of the matter is that there are not a whole lot of interventions. Most of them present some form of risk. The beleaguered caregiver of someone with A/D must opt for the potential solution that will keep things under control and do the least amount of harm.

My loved one has been diagnosed with ‘garden variety’ Alz. If nothing gets him first...With or without Risperdal....Alz. will kill him...and...the death will not be nice. My goal is make certain that he enjoys the highest quality of life until then.

Unlike most caregivers, I have not had to deal with paranoia, psychosis, or sundowning...but...we are only 3 ½ years into our A/D journey. When (and if) I have to deal with these problems, Melatonin will be my first remedy of choice. If it does not work...I will ramp up into other remedies and opt for others (both with and without black box warnings). Your links were especially helpful because they outlined potential side effects to be on the look out for.

Lisa---I read each and every word of your posts on this thread...Why don't you take some time to educate yourself about Alzheimer's?

If you did you would learn Alzheimer's is more than forgetting and that every one of the things that plagued your father prior to his death (as well as the inability to swallow and aspiration pneumonia) are normal for individuals with Alzheimer's. Sure...Some individuals may experience them sooner because of Risperdal...but...Not every individual with A/D is treated with it or other interventions having black box warnings.

lisa, i am so sorry for your loss. wish there were something that could be done today to change things. there is not.

before putting mom on each of the drugs supplements etc i have researched to find side effects such that 1. i could decide whether or not to use it and 2. be able to watch for these symptoms and get her off them as soon as possible if needed. when her legs swelled, we took her off haldol. when she became aggressive we took her off resperdol. serequil works wonders for her. without it and medical cannabis, she would face her remaining years in a home....her greatest fear. she is happily surrounded by children, grandchildren, great grand children, boyfriends, girlfriends and animals at the farm. all is as it should be.

i feel it is my responsibility to watch over mom. no one will care for her like i do. no one knows her base line like i do, therefore i am responsible....i am the only one who can be.

Lisa has placed this thread regarding her feelings about Risperdal on multiple forums.

The largest number of responses to Lisa can be found on the Caregiver's Forum, so I advise all to read those for more input on varied points of view and experience.

P.S. Lisa- will there be a lawsuit brought against the drug company on behest of your father?

Hi, Grassflower. There are currently two articles in the Alzheimer's Library on this subject. The one to which Lisa is referring was written by a well-known expert and is on the Alzheimer's Association website, Northern CA. The second is on this Alz Assoc website.

The goal of Alzheimers.boomja.com is to pull together in one place the highest-quality articles pertaining to AD. The Alz Assoc is more than welcome to weigh in on any articles posted there, and/or recommend articles that should be included.

Joanna, I have no idea at this point what will happen. My intentions have never been about money and when I first went to the nursing home last June, if they had done anything to even educate their staff, it would have ended there.
In reading the posts this morning, I don't think this is where I need to be. My Dad did not have Alzheimers and was simply labeled with dementia. I have educated myself and I understand what happens in the final stages of both diseases. He did not die from dementia, he died from Risperdal.
I am not in denial and I am not having a guilt trip for not taking care of him myself. My family did the best they could, all having families of their own to support, and we all loved him very much.
I posted as a warning to others. Before doing so I read several from people questioning the use of the drug. I also posted in the hopes of getting someone to help me bring national attention to this. Twelve states have wised up and put an end to this. If people don't understand that Big Drug Companies are financing the use of this drug and many others, not for the good of people but for profit, then they are the ones that are in denial and need to be educated.
That being said, God Bless and I wish all of you and your loved ones any peace and joy that can be found dealing with this horrible disease. Lisa MaKarrall

quote:

Originally posted by Johanna C.:
P.S. Lisa- will there be a lawsuit brought against the drug company on behest of your father?

I hate to see that "twelve states have wised up and put an end to this." What a shame for those who live in those states and will no longer have access to Risperdal. My mom was put on this medication, but we discontinued it after two days as it was "zombifying" her (sorry for the lack of a better word.) When her doctor prescribed it, she called me at home and told me of the risks. I felt that it would be a blessing if my mom died from a massive heart attack instead of going through all the stages of AD. I still feel that way (and my mom did pass from this wicked disease).

It is important to truly understand that vast numbers of people have been helped by these medications when everything else had been tried and there were no other alternatives. Many people have been able to stay home much longer and to have a decent quality of life restored secondary to these meds. This has been seen here in this country as well as internationally.

Then there are the patients who are not helped by these meds, who have negative reactions or whose risks fall more heavily into the category of the black box warning. If a person has a pre-existing cardiac condition or stroke history, then of course, this would probably not be the medication of choice as that rachets up the risk.

There are risk to benefit ratios for many, many medications in common use for many types of health issues.

Abuse of and over-prescribing of or inappropriate prescribing of ANY medications is not acceptable and this should be monitored.

It is recommended that when there is dementia present that our loved ones be seen by a specialist. ONE DEMENTIA IS NOT THE SAME AS ANOTHER. It is fundamentially critical that one knows which dementia is specifically present. A good Neurologist is considered the gold standard for accurate diagnosis of the many different types of dementia. There are often different treatments and contrindications of meds for some of the dementias, and Neuro also tends not to overmedicate.

It must also be remembered: Nursing homes do NOT prescribe medications. Nursing home staff do NOT prescribe medications. Neither can they change the dose of a medication unless there is a phyician order to do so. ONLY a physician can prescribe or modify medications.

Therefore, all medications prescribed prior to admission or while in a nursing home are medications that a physician has chosen for the patient.

NOTE: Lisa brings us an interesting discussion. I still recommend reading the many responses to her threds; in this light, please go to the Caregiver's Forum and read the input that has been written there by members of this community.

I wish everyone and their loved ones the very best.

Dear Lisa: Yes, you are indeed in the right place. This Online Community is for Alzheimer's Disease AND all other dementias.

There are many of us here who have loved ones that do not have Alzheimer's, and instead have a different related dementia, so this covers all of us. I happen to have one loved one with AD and one LO with a related dementia, FTD.

There are many different kinds of dementia, Alzheimer's is only one of them. It is very unfortunate that your father's specific type of dementia was not diagnosed. I am so sorry.

Do you know why his Neurologist or other specialist did not make an adequate diagnosis to the type of dementia present? Knowing this would have given the information needed to treat his specific problem in the best manner.

One never disregards the diagnosis and treats just the "symptoms" as meds used in one type of dementia may be contraindicated in another and can even cause the condition to become worse.

Lisa, you also mentioned that you posted here in hopes of getting someone to help you bring national attention to your cause.

You did get quite a bit of feedback, especially in the Caregiver's Forum. You have heard from many folks about their experience with Risperdal and Seroquel and found that their experience for their loved ones was different from yours.

I hope that reading these stories and experiences will also help you in understanding that while some patients will have a negative outcome to a medication, many, many, many will be helped by it. This of course does not negate your dreadful loss, but there are definitely two sides to this coin.

As mentioned before, this is so with many other drugs on the market unrelated to dementia.

I wish you peace and solace. If we can help you in another way, please do feel free to write once again.

My father, 85, just died 10 days ago after 2 doses of Risperadone - 0.5mg dosage. He had diabetes, and was on dialysis, and had been taking Aricept for several years with pretty good results. After his first dose, he was basically unable to hold his head up or stand, sit, or move any longer. He could barely make any vocal sounds and was unable to have dialysis that day, (Monday) and by Wednesday, he had died. His neurologist had prescribed this medicine, but I feel responsible, because I asked if there was something stronger than aricept because sometimes he was getting vocal and somewhat mean, which wasn't in his normal nature. If I had known this was a remote possibility, I would never have even tried it...but I never even looked it up...

quote:

Originally posted by Jan5447:
My father, 85, just died 10 days ago after 2 doses of Risperadone - 0.5mg dosage. He had diabetes, and was on dialysis, and had been taking Aricept for several years with pretty good results. After his first dose, he was basically unable to hold his head up or stand, sit, or move any longer. He could barely make any vocal sounds and was unable to have dialysis that day, (Monday) and by Wednesday, he had died. His neurologist had prescribed this medicine, but I feel responsible, because I asked if there was something stronger than aricept because sometimes he was getting vocal and somewhat mean, which wasn't in his normal nature. If I had known this was a remote possibility, I would never have even tried it...but I never even looked it up...

Jan, Would first like to welcome you to alz site. You will find caring people here that are having issues dealing with dementia diseases.
My sympathy on the loss of your father...It must have been such a hard loss. You must not blame yourself. If the doctor prescribed it, he felt your issues were real enough to try medication. Most meds have down sides and we never know when we or one of our loved ones will have that one in a million adverse reaction. Please don't hold yourself responsible for that choice.
Once again welcome and please come and share with us in forum or chat room.
Sheryl

Jan, please accept my condolences for your loss. Even after months and years of struggling with this disease, the final goodbye is so hard.

Please do not blame yourself for the choice you made. Lots and lots of people have found Risperadone to be a godsend to ease their LOs agitation. Every drug, even aspirin, has potential side effects. And it is entirely possible that your father's death was coincidental to the Risperadone, not a direct result. All any of us can do for our LOs is make the most logical choice for their comfort. You chose to relieve his agitation, which was definitely a kindness to him. Your motives were pure. Do not blame yourself for his death.

((Hugs)) May I invite you to visit the forum for Caregivers who have lost their LOs? You will find much warmth and support there.

Oh, Jan... ((((hugs)))) I'm so sorry for the loss of your father.

Songbird is right, I think. It sounds as if your father's death coincided with starting the med, but may not have been caused by it at all.

In the studies that led to the "black box" warning, the deaths that were seen appeared to be due to infections (e.g., pneumonia) or cardiovascular problems (e.g., sudden heart failure). And they've never actually found a mechanism that explains how these drugs might contribute to a higher possibility of dying -- many doctors/researchers are not convinced they actually do.

It sounds as if your father had a number of co-morbidities, any one of which may have been responsible for his passing like that.

All any of us can do is make our best guess about what might be helpful for our loved ones, and go with it. You made a loving choice, in an attempt to help your father have a better life. Your neuro clearly felt it was the right choice, under the circumstances. None of us has a crystal ball.

Please take Songbird up on her invitation to visit the forum for caregivers who have lost their loved ones:

http://alzheimers.infopop.cc/e...s/a/frm/f/3621033452

We all need help in dealing with our grief.