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Injectable Longer-Lasting Zyprexa May Be Approved

Posted by Jane Akre
Wednesday, February 06, 2008 12:02 PM EST
Category: On The Road, Major Medical, Protecting Your Family, In The Workplace
Tags: Zyprexa, FDA and Prescription Drugs, Toxic Substances, Wrongful Death

Inject Zyprexa into the muscle and it will last 2 to 4 weeks. Advisers to the FDA are considering recommending approval

Image Source:  Zyprexia.com 

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Eli Lilly’s schizophrenia drug, Zyprexa has a longer lasting cousin. Federal advisers at the FDA will vote Wednesday to determine whether it should be approved for the market.

Outside experts will weigh in on Zyprexa Adhera. This is the injectable form of the drug which lasts up to four weeks. Currently Zyprexa is taken by pill once a day to treat schizophrenia and bipolar disease.

An addition downside to the already controversial drug appears to be excessive sedation seen among some patients—that could win it a “black box” warning reserved for the most serious side effects a drug can have.

A memo written by Thomas P. Laughren, the FDA's psychiatry products division director, and posted on the agency's Web site, said clinical studies of the drug showed 24 out of 1,915 patients exposed to the long-acting form of Zyprexa suffered from profound sedation after receiving the injection. The FDA said the sedation typically lasted about one to three hours.

Lilly believes the sedation problem is due to incorrectly injecting the drug. 

Zyprexa (olanzapine) already has been linked to an increase in the number of deaths including heart attacks and strokes among elderly patients with dementia. Irregular heartbeat, sweating, liver problems, weight gain and diabetes, among other problems are linked to Zyprexa.

In October 2002, the FDA heard testimony from a mother whose son died after taking Zyprexa. She discourages a cozy relationship between the FDA drug money in conducting research.  Zyprexa reviewers are often recipients of money from drug maker, in this case Eli Lilly.

In January of 2007, Eli Lilly agreed to pay $500 million to settle 18,000 lawsuits from people who claimed they developed diabetes after taking Zyprexa.

The drug is frequently prescribed “off-label” and to children, accounting for it being a best-seller for Eli Lilly since schizophrenia is only estimated to affect .55 percent of the population.  

Zyprexa sales were $1.67 billion in the last quarter of 2007.

FDA whistleblower Dr. David Graham says the drug should be monitored more closely for weight gain and diabetes. 

The FDA is not required to follow the panel’s advice but often does.  #

Forum Link - Zyprexa


5 Comments

Posted by Daniel Haszard
Wednesday, February 06, 2008 12:40 PM EST

Long lasting Zyprexa?
Lilly needs to get a grip on issues with it's original formula.
About 30 state attorneys general have subpoenaed documents detailing Lilly's sales practices for Zyprexa as part of a civil investigation under state consumer protection laws.

Anonymous User
Posted by Jane Akre
Wednesday, February 06, 2008 4:13 PM EST

Daniel-

I understand you had an experience with Zyprexa. Care to share here at Injuryboard? It's always good to hear first hand experience.

Thanks so much!
Jane A.

Posted by Daniel Haszard
Friday, February 08, 2008 2:29 AM EST

I took Zyprexa for 4 years 1996-2000 (before the black box warning) at $250 a month co-pay.I got a shocking BG (blood sugar) of 500 in 2000.My doctors say it WAS the zyprexa that caused it.I have NO diabetes in my family.

Moreover,I was given it off-label for PTSD.

I have sent 5 certified letters to Eli Lilly operatives including their Pepper and Hamilton lawfirm as far back as two years ago,asking to be included in their 'promised' $1.2 billion settlement.

I signed releases for them to contact my Doctor for my medical records,at my last Doctor's visit he informed me that he has never been contacted.

This is disapointing to learn that they are stonewalling my case.

Posted by Randall Watters
Friday, February 08, 2008 10:57 AM EST

Danny, what would you say was the biggest mistake Lilly made in marketing this drug?

Posted by Daniel Haszard
Friday, February 08, 2008 1:29 PM EST

In a word "VIVA ZYPREXA"

Zyprexa off label promotion scandal is all over the news now.
Lilly drug reps are alleged to have called their marketing ploy,"Viva Zyprexa".

Zyprexa which is only FDA approved for schizophrenia (.5-1% of pop) and some bipolar (2% pop) and then an even smaller percentage of theses two groups.
So how does Zyprexa get to be the 7th (some say 5th) largest drug sale in the world?

Eli Lilly is in deep trouble for using their drug reps to 'encourage' doctors to write zyprexa for non-FDA approved 'off label' uses.

The drug causes increased diabetes risk,and medicare picks up all the expensive fallout.There are now 8 states (and counting) going after Lilly for fraud and restitution.

Only 9 percent of adult Americans think the pharmaceutical industry can be trusted right around the same rating as big tobacco.

Comments for this article are closed.

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