Zyprexa (Olanzapine) Warning!

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

http://www.researchprotection.org

Contact: Vera Hassner Sharav

212-595-8974

e-mail: veracare@...

FYI

Since 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, 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-- 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 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.

© Health News Digest.com 2002 .

_________________________________________________________________

Chat with friends online, try MSN Messenger: http://messenger.msn.com