note: scroll down and there is a second article on the entire class of drugs, that are all potentially deadly.
Why is it still on the market? You think it might be because those of us labeled as mentally ill are not valued the same as people without psychiatric labels?
Please read Furious Seasons for more information.
UPDATE: Furious Season’s no longer exists, so I’m cutting and pasting the post below.
Take note this was many years ago and zyprexa has killed many more thousands since.
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.
Here is an earlier post also from Furious Seasons, by Philip Dawdy:
September 19, 2007
Worse Than Vioxx: Zyprexa, Risperdal, Clozaril, And Paxil Killed Thousands Of Americans
Last week, there was much media coverage of a large jump in adverse events reports and deaths due to the use–and, perhaps, misuse–or prescription drugs. Most of the coverage cited the general trend, noted how many thousands of deaths occurred among users of opiate painkillers, and moved along. I wrote about the study here, but at the time had not obtained the entire paper. I have rectified that situation.
What the media failed to report is that Zyprexa, Risperdal, and Clozaril, three atypical antipsychotics, and Paxil, an SSRI anti-depressant, were tied to the deaths of 6,225 Americans from 1998 to 2005. These numbers are shocking and far outpace estimates I’ve run into previously. That this data was not reported by the media is inexcusable, given the millions of Americans–and others around the world–who take these four drugs.
The numbers come from a study in the Archives of Internal Medicine and are based upon reports in the FDA’s adverse events database. There are limits to the numbers from this study. I’ll get to those in a bit. The study may be accessed here.
Since news broke around Zyprexa last year and accusations that its maker, Eli Lilly, had downplayed and covered up known injuries caused by the drug, the media has not provided an accounting of how many people died as a result of taking the drug. For my part, I downplayed the numbers I ran across in press accounts and in the Zyprexa documents. I didn’t want to cast false aspersions.
But, now, I can say this: Eli Lilly, your drug killed 1,005 Americans. And, Janssen/J&J: your drug killed 1,093 Americans. GSK and makers of generic Paxil: you guys make a drug that killed 850 Americans. As for Novartis, makers of Clozaril, and whomever makes its generic form: you asshats killed 3,277 Americans. The doctors who prescribed these drugs are just as responsible, ethically if not legally.
And I have a question for you guys: How’s it feel?
Excepting Paxil, each of these drugs killed more people than Vioxx, which claimed 932 lives, according to the study. Vioxx was pulled from the market in 2004, following intense publicity around its association with heart attacks. Some estimates of deaths related to Vioxx go as high as 55,000 deaths, but I don’t know how solid those numbers are.
Zyprexa, Risperdal, Clozaril, and Paxil are all still on the market in the US. Zyprexa and Risperdal account for about $8 billion in sales each year. Why are these drugs still available? Partly because the FDA allows them to remain on-sale, partly because researchers continue to go to bat for these drugs, and partly because the media has failed to adequately police these issues (the New York Times gets a pass from this criticism).
Back in 2004, America’s media spilled ink all over the street about Vioxx. Good, decent, hard-working Americans taking that drug for arthritis and other pains were having heart attacks and dying out of the blue. That wasn’t right–any editor could understand that–and the media responded appropriately.
So why is it that the New York Times was virtually alone in reporting on Lilly’s attempts to downplay problems with Zyprexa and accusations that it marketed the drug off-label? The documents were in the hands of NPR, theWall Street Journal, and the Washington Post–and yet these media giants remained largely silent. Wimps.
I know some far-flung reporters are trying to now play catch up. Good for them. Just a note for you guys: Zyprexa and Risperdal aren’t just so-called “crazy people” drugs, or for schizophrenia and chronic mania, if you prefer. They were actively pushed by their makers for use in lighter forms of bipolar disorder, depression, and dementia–hardly the crazy folks the media seems to have been willing to blow off as unimportant somehow, at least in comparison with the solid citizens being wounded by Vioxx. And, these drugs were actively pushed for long-term use, not just a day or two here and there. Most outrageously, Risperdal, a drug associated with over 1,000 deaths, is used in children–and the FDA approved its use. In the case of child bipolar disorder, Risperdal is being used in children when psychiatrists cannot even agree upon whether the diagnosis exists and if using atypicals is an appropriate response.
Something is deeply wrong with this picture and its time for this rotten situation to be cleared up. That means it’s time for the FDA, Congress and the media to do their jobs. And it’s time for the doctors who prescribe these drugs to wake up and recognize that you are endangering your patients.
What I find puzzling is that I’ve been told by numerous practitioners that no one prescribes Clozaril anymore due to known problems with the drug. But the Archives report also contains data on non-fatal adverse events and breaks them out by year between 1998 and 2005. There were more adverse events reports for Clozaril in 2005 than there were in 1998. I’ve been told that Paxil scripts are way down too, but in 2005 there were over twice as many adverse events reports for the anti-depressant as in 1998. Some of this can be explained by the argument that the adverse events reporting system is still fairly new, that reporting is voluntary, that other factors may explain the events (for example, multiple drugs in the same patient) and that the boost in events reports in the last few years can be explained by lawyers pushing clients to file reports with the FDA. Maybe.
Keep in mind that if lawyers were really pushing their clients to file adverse events reports willy-nilly, then there would be approximately 30,000 or more adverse events reports in the FDA system for Zyprexa alone–one for each plaintiff in lawsuits already settled by Lilly. According to the study, there are only 4,110 adverse events reports on file for Zyprexa. By comparison, 8,698 adverse events reports were filed for Vioxx.
Why aren’t there 30,000 or so events reports for Zyprexa, for example? Likely because plaintiffs who settled claims against Lilly signed a confidentiality agreement and are reportedly muzzled from speaking to the press about their experiences and probably also believe that they cannot make reports to the FDA. That’s some breathtaking legal advocacy by Lilly’s outside attorneys and some bizarre work on the bench by US District Court Judge Jack Weinstein.
As for adverse events as a whole, several psych meds had more than 500 adverse events reports between 1998 and 2005. In order and using brand names:
Some of the Depakote, Tegretol and Lamictal events could be as a result of their use in epilepsy. Cymbalta’s reports would be based on less than two years of patient experience since the drug was approved in 2004.
I’m not trying to ignore the rest of the world, but I simply don’t have access to many numbers concerning these drugs in other countries, except for the 399 deaths recently reported among Australians who were given atypical antipsychotics.
In closing, I want to cycle back to a post I did over a year ago. In it, Igroused that a thought leader in the medical community had told me that Zyprexa’s use was, on the whole, therapeutic for patients. I wonder if he’s even read the Archives study.