Zyprexa--Important information


Olanzapine (Zyprexa, Zyprexa Zydis, Zalasta, Zolafren, Olzapin, Rexapin or in combination with fluoxetine Symbyax) is an atypical antipsychotic, approved by the FDA for the treatment of: schizophrenia on September 6, 1996

As with all neuroleptic drugs, olanzapine can cause tardive dyskinesia and rare, but life-threatening, neuroleptic malignant syndrome...

Other recognised side effects may include:

* Aggressiveness
* akathisia inability to remain still[5]
* dry mouth
* dizziness
* irritation
* sedation
* insomnia
* urinary retention
* orthostatic hypotension
* weight gain (90% of users experience weight gain) (see below)
* increased appetite
* runny nose
* low blood pressure
* impaired judgment, thinking, and motor skills
* impaired spatial orientation
* impaired responses to senses
* seizure
* trouble swallowing
* dental problems and discoloration of teeth
* missed periods
* problems with keeping body temperature regulated
* apathy, lack of emotion

Metabolic effects

The Food and Drug Administration requires all atypical antipsychotics to include a warning about the risk of developing hyperglycemia and diabetes, both of which are factors in the metabolic syndrome. These effects may be related to the drugs' ability to induce weight gain, although there are some reports of metabolic changes in the absence of weight gain.[citation needed] Of all the atypical antipsychotics, olanzapine is one of the most likely to induce weight gain based on various measures.[6][7][8][9] The effect is not dose dependent. Olanzapine may directly affect adipocyte function, promoting fat deposition.[10] There are some case reports of olanzapine-induced diabetic ketoacidosis.[11] Olanzapine may decrease insulin sensitivity[12] though one 3-week study seems to refute this.[13] It may also increase triglyceride levels.[7]

Despite weight gain, a large multi-center randomized NIMH study found that olanzapine was better at controlling symptoms because patients were more likely to remain on olanzapine than the other drugs.[14] One small, open-label, non-randomized study suggest that taking olanzapine by orally dissolving tablets may induce less weight gain,[15] but this has not been substantiated in a blinded experimental setting...

Further information: Eli Lilly Controversy

According to a New York Times article published on December 17, 2006,[27] "Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers", most of which had been disclosed as the result of lawsuits by the mentally ill against the company though some had been stolen.[28] These had been sent to a number of journalists by a lawyer advocate for mentally ill opponents of psychiatric treatment. Eli Lilly filed a protection order to stop the dissemination of certain Eli Lilly documents about Zyprexa which they, and the judge, believed to be confidential and "not generally appropriate for public consumption".[28] Temporary injunctions required those who had been received the documents to return them and that the documents be removed from websites which had posted them.[29] In his final judgement, Judge Weinstein issued a permanent judgement against further dissemination of the documents and requiring their return by a number of parties named by Lilly.[28] These health risks include an increased risk for diabetes through Zyprexa's links to obesity and its tendency to raise blood sugar. Zyprexa is Lilly’s top-selling drug, with sales of $4.2 billion last year.

The documents, given to The New York Times by Jim Gottstein, a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes. The Times of London also obtained copies of the documents and reported that as early as October 1998, Lilly considered the risk of drug-induced obesity to be a "top threat" to Zyprexa sales.[30] In another document, dated October 9, 2000, senior Lilly research physician Robert Baker noted that an academic advisory board he belonged to was "quite impressed by the magnitude of weight gain on olanzapine and implications for glucose."[30]

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, another study showed 16% of Zyprexa patients gained at least 30 kg (66 pounds) in one year, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004. In 2006, Lilly paid $700 million to settle 8,000 lawsuits from people who said they had developed diabetes or other diseases after taking Zyprexa. Thousands more suits are still pending.[31]

In 2002, British and Japanese regulatory agencies warned that Zyprexa may be linked to diabetes, but even after the FDA issued a similar warning in 2003, Lilly did not publicly disclose their own findings.

Eli Lilly agreed on January 4, 2007 to pay up to $500 million to settle 18,000 lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa. Including earlier settlements over Zyprexa, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who claim they were injured by the drug. At least 1,200 suits are still pending, the company said. About 20 million people worldwide have taken Zyprexa since its introduction in 1996.[32] On January 8, 2007, Judge Jack B. Weinstein refused the Electronic Frontier Foundation's motion to stay his order.[33]

On January 15, 2009 Eli Lilly plead guilty to a misdemeanor charge of illegally marketing Zyprexa for off-label use, and agreed to pay $1.4 billion.[34]

In order to make up for the costs for settling the lawsuits and shrinking sales figures for Zyprexa in the U.S.A. the company increased the prices for this medication in Germany in May 2007 by 18 percent. [35] [36]


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