November 17, 2008

FDA Finds Zyprexa Has Killed 3,400 People, Worse Than Vioxx

I was reviewing an FDA staff document this morning, wherein FDA staffers recommend additional warnings for Zyprexa for pediatric cases (ie, teens) and ran across a startling statistic. According to the agency's own adverse events database summarized in the report, the controversial atypical antipsychotic has killed 3,455 people (see page 7 of the above document) between 1997 and early 2008.

Roughly half of the deaths are known to have occurred in the US while the remainder are from unidentified locations (likely a mix of US and foreign deaths).

What startles me is that last fall I reported on a study of the FDA's adverse events database in which researchers reported that Zyprexa had killed 1,005 people from 1998 to 2005, so this new accounting represents a large increase in deaths associated with the drug. Even more, according to that same study, Vioxx had killed 932 people. So why do Vioxx cases get all the media attention while Zyprexa does not? Why is Zyprexa still on the market and raking in $4 billion or so a year in sales while Vioxx is off the market?

Why on earth has this drug been marketed for casual use far beyond its initial use as an antipsychotic?

As of now, Zyprexa is not approved for use in children and teens, but Eli Lilly has an application before the FDA to gain approval for its use in teens diagnosed with schizophrenia. Amazingly, one published study of Zyprexa in teens found that in a three-week trial of the drug patients gained an average of eight pounds, which is a lot for such a short time period. That's why the FDA staff in the above document is recommending additional warnings about weight gain in pediatric populations.

(Via Pharmalot.)

Posted by Philip Dawdy at November 17, 2008 09:51 AM
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Comments

Hi Philip,

The report of Zyprexa deaths is on page 5, not page 7.

To think that Eli Lilly was once required to take the drug Oraflex off the market because there were 42 deaths.

This is all so sickening and such a National Tragedy.

Posted by: Rosie at November 17, 2008 10:36 AM

weird. it's one page 7 pf the dowloaded pdf.

Posted by: Philip Dawdy at November 17, 2008 11:03 AM

My heart goes out to all those who lost a loved one on Zyprexa. Is there any way to reach a larger audience with this horrifying statistic of 3,455 deaths on Zyprexa?

Besides the over 2,700 tragic stories documented by the media on www.SSRIstories.com , the adverse reaction report for 7 years [from 1988 through 1995] for Prozac alone revealed 159 deaths [121 deaths and 38 sudden deaths] and 2,246 suicide attempts. This document obtained through the Freedom of Information Act does not list the number of completed suicides. Here is the Website: http://www2.netdoor.com/~bill/prosurv/fda95adr.html

Posted by: Rosie at November 17, 2008 11:05 AM

Yes, there should be more forceful warnings about metabolic side-effects associated with taking Zyprexa, but with they right precautions, it can be a safe and effective medication, especially when all else has failed. I take it for a psychotic disorder which came close to either killing me or landing me in jail. I tried over a dozen different meds and even therapy. All failed. Only Zyprexa helped. My doctor was upfront with the side effects. We monitered my glucose and lipids and I changed my diet accordingly. I have even been able to lose weight while taking this medicine. I believe that such measures have to be taken with Zyprexa for it to be safe. If lifestyle changes can't be taken or are not effective, then Zyprexa may not be right for that person. But when all else fails, aside from Clozaril (which is even more dangerous), Zyprexa seems to work (according to the Carlat Report) and that is why with all of its problems, doctors still grudgingly turn to it.

Posted by: Tony at November 17, 2008 11:05 AM

All deaths caused by psych-drugs are easy to conceal.
If one people claims that "-This drug has saved my life. If it wasn't for .... side effects are easy to cope blah blah blah...!"

Are there family members claiming and proving that X drug has killed a loved person?

Posted by: Ana at November 17, 2008 11:30 AM

While everyone's body is different and some meds are effective for some people while others aren't, the issue here is the number of deaths associated with the drug.

Vioxx was one of the VERY few anti-inflammatory meds that did ANYTHING for me. Celebrex was useless and Bextra was only effective in combination with a muscle relaxant, but because 900-odd people died, I can no longer obtain Vioxx despite its effectiveness for me.

Zyprexa, by contrast, is used by far fewer people than Vioxx (which was commonly prescribed as a non-narcotic pain medication and thus given out to a LARGE number of patients) yet has far more deaths. Proportionately, this suggests that Zyprexa is FAR more dangerous than Vioxx to the people who are taking it due to the smaller number of people using it and the vastly greater number of deaths reported.

Posted by: Puckett at November 17, 2008 01:04 PM

Perhaps I'm not reading this right, but according to the document you linked to it only says that there is 76 deaths...

My document says it was created on the 11th of the september.

Posted by: Felix at November 17, 2008 06:17 PM

I appreciate the Zyprexa Chronicles and your relentless pursuit of exposure of the truth regarding this antipsychotic, Philip.

For my daughter to have been placed on 15mg. per day as an 11 year old in 1999 for a wrong diagnosis; it gives me enormous relief based on a decade of grief---that Zyprexa did not kill her.

It killed Ellen's son, and many other innocent people.

The fact that Lilly buried data is just so horrific to me, as a mom, let me tell all how many doctors told my youngest daughter of 3--"be glad you have this illness now, when Zyprexa was 'invented'."

Then her muscles bothered her, then her eyes rolled up in her head so she could not read, she was agitated, restless, and aggressive.

By age 17, she read the information about diabetes herself and went off the drug; by this time her brain, as far as I am concerned, had become addicted to the drug. She suffered severe withdrawal psychosis as a result, and then suffered 15 drug trials afterward by doctors who trialed Abilify, Seroquel and other "latest great new meds".

To be told a child who is brilliant that they are a morph and retarded---(but just months before was a 4.0 GPA Honor Society junior in high school) was awful, painful and I know the truth.

Zyprexa caused my daughter 100 lb weight gain at age 11; and loss of so much of her life. Teens, friends, hell she was called "the beast" by boys in the lunchroom.

I know I am a broken record here, like gum on your shoe on a hot summer day---annoying and wordy.

But who else will ever be able to speak for this?

My daughter can't. Ellen's son can't.

My daughter is disabled, and she is alive is where I have to give my thanks.

Posted by: Stephany at November 17, 2008 06:18 PM

felix it's on page 7 of the pdf i downloaded, section 3.1 table 1 where it clearly reports 3,455 total deaths. you are looking at something else. the reason it's printed as page 5 is because the document has two unnumbered pages at the beginning but the pdf reader i use calls it page 7.

Posted by: Philip Dawdy at November 17, 2008 07:05 PM

Actually, take that back. I found your number

Posted by: Felix at November 17, 2008 10:12 PM

Dear Philip:

This is just like M&M’s; they melt your mind, not your hands. It's so comforting to know the youth of America are in the Good Hands People of Psychiatry!
3400+ deaths and counting! When does the real madness STOP!
TOOT! TOOT! The Money and Pill train just pulled into the station. Time to off load the corpses ,and stop by the bank the government just bailed out, and make a deposit.

Yours Truly
Stan

Posted by: stan at November 18, 2008 08:33 AM

Just a quick note.

According to the FDA in 2005, Vioxx has been responsible for between 89,000 and 140,000 deaths in the U.S. alone.

Just to put things in perspective, which is not to say that Zyprexa should be used indiscriminately. Rather, it should only be used in situations where the evidence deems the benefits outweigh the risks, because the risks are certainly dangerous.

Take care.

Posted by: dguller at November 21, 2008 08:59 PM

The blogger is confusing deaths while ON Zyprexa with deaths FROM Zyprexa. BIG, big difference. Get the facts. Don't distort.

Philip Dawdy responds: no distortion here. zyprexa has killed thousands who were either the drug or who died as result of damage caused by the drug. stop being the kind of doctor who tries to cover up the truth.

Posted by: REALDOC at February 3, 2009 06:45 PM
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