Posted by JohnV on February 26, 2003, at 15:04:29
In reply to Re: Anyone on typical antipsychotics?, posted by stjames on February 26, 2003, at 14:27:05
> My experience is they all cause TD or EPS
> at far too high a rate to be a resonable >treatment for all but the most ill psychotic >persons.I honestly don't want to get into a warfare or argument about this, and I am open to debate no matter what the outcome. But, there are also proven very dangerous side effects (as in sudden death, diabetes, ketosis, etc..) with atypicals that have been greatly understated.(The finger seems to point at Zyprexa as the main culprit here..with Seroquel being more neutral. I am concerned because Zyprexa seems to be the Prozac of AP's with it's being prescribed for everything and almost anything. If it where safer, I'd see no problem.) I have seen a number of people suffer quite horridly from various diabetic effects, even if they are properly treated, and I guess that is where my concern is. Diabetes is a deadly serious disease.
My pdoc directed me to this information when it first came out. He is not against prescribing these meds, but echoed a number of calls for research that compares much lower doses of some typical antipsychotics with atypicals. (Most research with typicals use very high doses.) Again, I don't want to argue...really..but these are important factors we should weigh and know about as consumers.
Here are a number of research pieces I pulled from a few sites:
ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)
http://www.researchprotection.orgAntipsychotics and Diabetes
Contact: Vera Hassner Sharav
212-595-8974
e-mail: veracare@rcn.com
FYISince they arrived on the market in the 1990s, the so-called 'atypicial' antipsychotic drugs have been wrapped in controversy and promotional hype by drug companies and their paid professional spin masters who made bald claims about their "favorable side effect profile" referring to them as "breakthrough" "miracle" drugs that "balance the chemistry" in the brain.
In his book, Mad in America, Robert Whitaker relied on data available to the FDA but not made known to most doctors who prescribe these drugs or to patients and families. In clinical trials prior to FDA approval: "One in every 145 patients who entered the trials --for risperidone, olanzapine, quetiapine, and a fourth atypical called sertindole--died, and yet those deaths were never mentioned in the scientific literature." (p. 269)
It can be said, therefore, that contrary to what psychiatrists have been telling patients and their families, the drugs prescribed for schizophrenia have severe undesirable side effects. For some individuals, the side effects are fatal.
On July 1, 2002, Duke University issued a Press Release about the most recent finding that links the new anti-psychotics to early onset diabetes. The team of researchers--Elizabeth A. Koller, M.D. from the FDA, and Murali Doraiswamy, M.D. from Duke-- analyzed FDA's adverse drug report database, MedWatch (which receives 10% of adverse drug reports). They identified 289 cases of diabetes in patients who had been prescribed olanzapine (a.k.a. Zyprexa), Eli Lilly's most profitable drug.
The researchers reported: "Of the 289 cases of diabetes linked to the use of olanzapine, 225 were newly diagnosed cases. One hundred patients developed ketosis (a serious complication of diabetes), and 22 people developed pancreatitis, or inflammation of the pancreas, which is a life-threatening condition. There were 23 deaths, including that of a 15-year-old adolescent who died of necrotizing pancreatitis, a condition where the pancreas breaks down and dies. Most cases (71 percent) occurred within six months of starting the drug and many cases were associated with moderate weight gain."
The evidence from pre-marketing trials was also alarming: Whitaker wrote: "Of the 2,500 patients in the trials who received olanzapine, twenty died. Twelve killed themselves...Twenty-two percent [ ] suffered a 'serious' adverse event, compared to 18 percent of the haloperidol patients. Two-thirds of the olanzapine patients didn't successfully complete the trials...."(p. 281)
According to the Duke researchers, many cases of diabetes have also been reported with other antipsychotic drugs. In 1994, a Duke team first reported a Diabetes link to the first 'atypical' antipsychotic drug, clozapine: last year, 384 reports of diabetes last year were associated with clozapine.
Whereas the British Medical Control Agency and the Japanese Health & Welfare Ministry have issued warnings about the risk of diabetes for patients prescribed Zyprexa, FDA has remained silent.
It is astounding to AHRP that the FDA has approved a clinical trial that exposes teenagers-- who are not even diagnosed with schizophrenia-- to a drug that puts them at risk of diabetes. The trial is being conducted at Yale University. [See, AHRP complaint filed with the federal Office of Human Research Protection at: http://www.researchprotection.org/Initiatives/YaleComplaint.html
http://www.eurekalert.org/pub_releases/2002-07/dumc-rwa062802.php
Antipsychotic Drug Might Be Linked to Diabetes
HealthNewsDigest.com - July 01, 2002
RESEARCHERS WARN ANTIPSYCHOTIC DRUG MIGHT BE LINKED TO DIABETES
DURHAM, N.C. - Research from Duke University Medical Center suggests there might be a link between at least one drug used to treat schizophrenia and the onset of diabetes, a disease widely recognized as one of the leading causes of death and disability in the U.S.The drug, olanzapine (trade name Zyprexa), belongs to a relatively new family of medications called atypical antipsychotics, which are used to treat schizophrenia, paranoia and manic-depressive disorders. Other drugs in this class include clozapine, risperidone, quetiapine and ziprasidone.The researchers found metabolic abnormalities ranging from mild blood sugar problems to diabetic ketoacidosis and coma in patients who had been prescribed olanzapine, most of whom were otherwise not known to be diabetic.
Diabetic ketoacidosis (DKA) is a serious condition in which a person experiences an extreme rise in blood glucose level coupled with a severe lack of insulin, which results in symptoms such as nausea, vomiting, stomach pain and rapid breathing. Untreated, DKA can lead to coma and even death.
"While our report does not prove a causal relationship between the drug and diabetes, doctors should be aware of such potentially adverse effects," said P. Murali Doraiswamy, M.D., a psychiatrist at Duke and co-author of the study. "We've found cases where patients had some very serious problems associated with olanzapine, and at least 23 of them died."
The findings appear in the July 2, 2002 issue of Pharmacotherapy. The research was self-supported by the authors. Doraiswamy and Elizabeth A. Koller, M.D., lead author of the study and a medical officer at the FDA, queried the FDA MedWatch Drug Surveillance System, MEDLINE (a biomedical database) and selected abstracts from national psychiatry meetings over a period of eight years and identified 289 cases of diabetes in patients who had been given olanzapine. Of the 289 cases of diabetes linked to the use of olanzapine, 225 were newly diagnosed cases.
One hundred patients developed ketosis (a serious complication of diabetes), and 22 people developed pancreatitis, or inflammation of the pancreas, which is a life-threatening condition. There were 23 deaths, including that of a 15-year-old adolescent who died of necrotizing pancreatitis, a condition where the pancreas breaks down and dies. Most cases (71 percent) occurred within six months of starting the drug and many cases were associated with moderate weight gain.
"The average age of adults showing signs of diabetes after taking olanzapine was about 10 years younger than what is generally seen in the community," said Doraiswamy. "The younger age at onset plus the number of serious complications and the improvements reported when the drug was stopped all suggest a link to the disease. However, until we know if there are risk differences among drugs in this class, it is important for physicians to watch all patients receiving this medication for signs of diabetes so that it can be detected quickly and managed."
The study merely suggests an association between the drug and diabetes, said Doraiswamy. Further studies are needed to offer more conclusive evidence of a direct causal relationship. If future studies confirm the findings, he said that perhaps the FDA should consider including a stronger warning label for these drugs.
"The numbers are still sketchy since many adverse reactions are not reported to the FDA and we don't have a good handle on how many people have actually received these drugs," he cautioned. "Atypical antipsychotics can be life saving medications, but we need to learn more about their long-term side-effects. I think this should be a high priority for investigation."
Doraiswamy was part of a team from Duke that first reported a link between the antipsychotic drug clozapine and the development of diabetes in a 1994 issue of the American Journal of Psychiatry.
Last year, Koller reported in the American Journal of Medicine that the FDA had received 384 reports of diabetes associated with the drug clozapine. According to the researchers, many cases of diabetes have also been reported with other antipsychotic drugs. Doraiswamy has previously received funding and consulting fees from all companies that currently manufacture antipsychotic medications, including Eli Lilly and Company, the manufacturer of Zyprexa.
(c) Health News Digest.com 2002 All Rights Reserved.
Warning About Antipsychotic Drug
DURHAM, NC -- July 1, 2002 -- Research from Duke University Medical Center suggests there might be a link between at least one drug used to treat schizophrenia and the onset of diabetes, a disease widely recognized as one of the leading causes of death and disability in the U.S.The drug, olanzapine (trade name Zyprexa), belongs to a relatively new family of medications called atypical antipsychotics, which are used to treat schizophrenia, paranoia and manic-depressive disorders. Other drugs in this class include clozapine, risperidone, quetiapine and ziprasidone.
The researchers found metabolic abnormalities ranging from mild blood sugar problems to diabetic ketoacidosis and coma in patients who had been prescribed olanzapine, most of whom were otherwise not known to be diabetic. Diabetic ketoacidosis (DKA) is a serious condition in which a person experiences an extreme rise in blood glucose level coupled with a severe lack of insulin, which results in symptoms such as nausea, vomiting, stomach pain and rapid breathing. Untreated, DKA can lead to coma and even death.
"While our report does not prove a causal relationship between the drug and diabetes, doctors should be aware of such potentially adverse effects," said P. Murali Doraiswamy, M.D., a psychiatrist at Duke and co-author of the study. "We've found cases where patients had some very serious problems associated with olanzapine, and at least 23 of them died."
The findings appear in the July 2, 2002 issue of Pharmacotherapy. The research was self-supported by the authors.
Doraiswamy and Elizabeth A. Koller, M.D., lead author of the study and a medical officer at the FDA, queried the FDA MedWatch Drug Surveillance System, MEDLINE (a biomedical database) and selected abstracts from national psychiatry meetings over a period of eight years and identified 289 cases of diabetes in patients who had been given olanzapine. Of the 289 cases of diabetes linked to the use of olanzapine, 225 were newly diagnosed cases. One hundred patients developed ketosis (a serious complication of diabetes), and 22 people developed pancreatitis, or inflammation of the pancreas, which is a life-threatening condition. There were 23 deaths, including that of a 15-year-old adolescent who died of necrotizing pancreatitis, a condition where the pancreas breaks down and dies. Most cases (71 percent) occurred within six months of starting the drug and many cases were associated with moderate weight gain.
"The average age of adults showing signs of diabetes after taking olanzapine was about 10 years younger than what is generally seen in the community," said Doraiswamy. "The younger age at onset plus the number of serious complications and the improvements reported when the drug was stopped all suggest a link to the disease. However, until we know if there are risk differences among drugs in this class, it is important for physicians to watch all patients receiving this medication for signs of diabetes so that it can be detected quickly and managed."
The study merely suggests an association between the drug and diabetes, said Doraiswamy. Further studies are needed to offer more conclusive evidence of a direct causal relationship. If future studies confirm the findings, he said that perhaps the FDA should consider including a stronger warning label for these drugs.
"The numbers are still sketchy since many adverse reactions are not reported to the FDA and we don't have a good handle on how many people have actually received these drugs," he cautioned. "Atypical antipsychotics can be life saving medications, but we need to learn more about their long-term side-effects. I think this should be a high priority for investigation."
Doraiswamy was part of a team from Duke that first reported a link between the antipsychotic drug clozapine and the development of diabetes in a 1994 issue of the American Journal of Psychiatry. Last year, Koller reported in the American Journal of Medicine that the FDA had received 384 reports of diabetes associated with the drug clozapine. According to the researchers, many cases of diabetes have also been reported with other antipsychotic drugs.
###
Doraiswamy has previously received funding and consulting fees from all companies that currently manufacture antipsychotic medications, including Eli Lilly and Company, the manufacturer of Zyprexa.
SOURCE: Duke University Medical CenterWeb Address :
http://www.docguide.com/news/content.nsf/EAC/8525697700573E1885256BE900554826?Open&type=DGNews
Atypical Neuroleptics Seen to Increase the Risk of Diabetes Mellitus Somewhat
Reuters Health Information 2002. (c) 2002 Reuters Ltd
IntroductionNEW YORK (Reuters Health) Apr 30 - Younger patients with schizophrenia are more likely to be diagnosed with diabetes if they are treated with an atypical neuroleptic drug as opposed to a conventional neuroleptic, data from a Veterans Health Administration study indicate. Dr. Michael J. Sernyak, of the VA Connecticut Healthcare System in West Haven, and associates identified more than 38,000 patients treated for schizophrenia in the Veterans Health Administration system for whom an antipsychotic drug was prescribed between June and September of 1999. Almost 60% were being treated with atypical agents, the investigators report in The American Journal of Psychiatry for April. In the group overall, there was no significant difference in the incidence of diabetes between those treated with clozapine, olanzapine, quetiapine, or risperidone and those receiving typical neuroleptics. Among patients younger than 60 years old, however, the rate of diagnosis of diabetes was significantly higher for those receiving atypical agents than for those receiving conventional antipsychotics. In the under-40 age group, 8.75% of those receiving atypical antipsychotics and 6.43% of those treated with typical agents were diagnosed with diabetes (p = 0.007), and for those between 50 and 59 years of age, the prevalence in the two groups was 22.73% versus 20.56% (p = 0.003). The VA research team suggests that the atypical drugs, rather than precipitating the onset of diabetes, hasten its onset among those at risk. In an interview with Reuters Health, Dr. Sernyak pointed out that the prevalence of diabetes is much higher among people with schizophrenia than in the general population. He suggests that patients be tested for fasting blood glucose levels twice a year, especially if they are being prescribed an atypical antipsychotic drug. On the other hand, he does not advocate going back to the conventional antipsychotics. Rather, physicians should discuss the risks with their patients. "Patients are willing to make incredible tradeoffs to stay free of psychosis," he emphasized. Am J Psychiatry 2002;159:561-566.
poster:JohnV
thread:204030
URL: http://www.dr-bob.org/babble/20030224/msgs/204056.html