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
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, the Wall 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.
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
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
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, I groused
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.
Posted by Philip Dawdy at September 19, 2007 12:28 AM
The medspeak for their screwups is "adverse health events" and I am
willing to bet that this suffers from massive under reporting.
"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
Excuse me while I sob, and send the link to my article I wrote after reading this entry.
Thank you Philip, for writing this, everyone please pay attention.
Not only has my daughter been prescribed Clozaril, it appears to help
her mind, and that of 60% of a local residential care facility accord
to the onsite psychiatrist who has 60% of his patients using it.
A Mother's Love:the advocacy journey, and Clozaril-Soulful Sepulcher
Your article is interesting and it is important to raise awareness to the precautions that need to be taken with these drugs.
However; the side effect related to Vioxx was heart failure and was
unkown in initial trials. When discovered that this was an
unpreventable and unpredictable side effect with no warning signs-the
medication was pulled.
While the main side effect you are referring to with the psychotropic
meds is an increased risk of suicide. There are MANY precautions and
guidelines for these meds in regard to the increase in suicidal
ideations. Patient education is key here.
While the possibility of an increase in suicidal thought related to
these drugs is extremely important; the responsability lies also with
the physicians, the patient and the families to observe closely for any
increase in increased symptomatology.
I am not defending the pharmacuetical industry. However; you cannot
bash these companies without realizing that there is accountability on
all sides. These drugs have also SAVED millions of lives. A point you
seem to have forgotten.
thanks maggie. as far as the antipsychs go, the main causes of death
appear to be diabetes, pancreatitis and cardiac problems, not suicides
as is more common with the anti-depressants. i'm not sure what patient
education would do about pancreatitis
Point well taken in general--many of these drugs are directly
dangerous. But to deal narrowly with the antidepressants for a minute,
which have not been shown to cause any physiological disturbance even
sort of similar to the antipsychotics: these drugs are usually
prescribed to depressed people, and depressed people are at risk of
suicide whether or not they are medicated.
I can't find any reporting of what the adverse events actually were
(heart attack? stroke? suicide?), which would go a long way towards
clearing the issue up. But let's say that most or all of the adverse
events relating to the SSRIs were suicides. Then there is a correlation
between the drugs and suicide. And correlation is not causation.
Why is it okay to kill psych patients but Vioxx gets pulled to protect people in physical pain? Who's protecting us?
This is not pleasant reading. However, I've determined not to get
embroiled in a debate about side effects until somebody explains what
the benefit of these psychotropic drugs is - "efficacy" being the first
criteria, in assessment. If you think that this is a diversion, you
should take a look at the way the MHRA, in the UK, squirmed, when I
started quizzing it on this point:
Read back through July and August, principally. Rather than stand
and argue its position, it stonewalled me. It seems pretty plain that
these drugs don't work: that's the upshot, and the regulatory licensing
process appears to be designed not to pick this up.
When I go to the doctor I expect my doctor to make the determine
what is wrong with me. If the doctor is to write me a prescription I
expect the doctor to know exactly what will happen while on the
medication. This is the doctors job. This is what makes them the
doctor. If I make a suggestion as to what I might feel is the better
medication, because maybe I heard it has fewer side effects, I am told
flat out "I'm the doctor. I know what is best for you". (In another
words, "don't question me") Yes, I suppose if I had money and or
insurance I could pick another doctor. One willing to educate me
instead of ridiculing me. But hey, in the real world thats just not
possible. So, I leave my decission making to the educated doctor, who
has made it prefectly clear, he knows whats best! I leave the office
educated and assured that my doctor knows best and I needn't have any
concerns. There really is no reason for me to question it any further.
Maybe someone can explain to me just where am I suppose to get educated
about drug safety? We just learned my doctor really isn't interested in
me knowing anything except how smart he is. The websites listed on the
TV ads the drug company's display? Heck, their websites would surely
educate me to all the deaths and other serious side effects associated
with their drugs. Maybe you think I should be able to pull up the
actual research done on each drug I am prescribed. Yep, could probably
learn alot from those with my high school degree! But then again, since
it is only a couple doctors with their names on all the research, I
might get confortable in their writting styles and actually learn alot.
The fact is, I pay my doctor to know what he is prescribing me . I
expect the doctor to stay current on what he/she is prescribing. I
expect the doctor to file and adverse effect report. I expect my doctor
to encourage me and advise me to write a report. I expect my doctor to
question the research. I expect my doctor to question the authors of
the study, who paid for the study, the results of the study. I expect
to be helped, not harmed when taking a medication and it is the doctors
responsiblity to assure me that does not happen. Oh, and to tell me
someone else's life was saved on the same medication that killed,
caused diabetes, caused serious MI symptoms, heart disease in a love
one will not resolve the abuses of the drug companies and doctors and
make the drugs safer. The drug companies, researchers, prescribing
doctors and the FDA all have a responsibilty in assuring my safety.
Don't blame me for a lack of education, especially when there is no
place to be educated. Thanks to these blogs the general public is
getting assess to information that has been kept hidden.
My post pretains to the posted comment from Maggie
Jane how about this: my daughter when she was 17, researched Zyprexa
diabetes on her own, took the paperwork to her psych and he told her to
"take a walk" to lose weight. She FIRED him. [She had been on that drug
since she was 11, and it's only because of MY research that I knew to
watch for pancreatitus re: Depakote, and Polycystic Ovary
Syndrome[black box warning].She didn't get pancreatitus, but DOES have
Polycystic Ovary syndrome, a permanent DAMAGE that leaves a 19 yr old
most likely unable to have kids and has increased cancer risk.
Educating patients is something doctors do not do. I was also
told "I'm the doctor". "If your mother wanted to be a psychiatrist then
she should go to school to become one." "In my 30 years experience, and
I'm the doctor." ---the list goes on and on and guess what? I was right
ALL of the time, per topic that had been raised. One doctor did tell me
due to my SSRI information and suicidal ideation[per Zoloft in 2001
when my daughter was 13]that he was going to "re-think how I medicate
patients now due to your mother's research."[he told that to my
I WISH I didn't have to learn so much about chemistry, medications,
and see adverse affects in someone I love and try and convince a doctor
it was the med.
You're right, Zyprexa and Risperdal aren't just
so-called "crazy people" drugs. I was prescribed Risperdal and Seroquel
(at different times) for SSRI and SNRI induced insomnia. I was being
treated for recurrent major depression, not psychosis. Antipsychotics
for insomnia, it's all the rage these days.
I was actually quite surprised with the numbers of reported adverse
events from psych meds. It's nice to see that some doctors are
Maybe part of the problem when to it comes to reporting adverse
effects with psych meds is that so many patients these days are on more
than one at a time. It's probably not that easy to isolate the culprit.
I was on Effexor, Wellbutrin, Lamictal, and a couple of others thrown
in to the mix. Then, they take you off one and put you on another,
increase this one, decrease that one. So, who knows what caused what.
I realize that taking any drug involves risk. I would, however, like
to be the one to choose what risks I am willing to accept. That should
always be the patient's decision. I'm not willing to risk diabetes,
weight gain, and tardive dyskinesia to address problems with insomnia.
If that made me a bad psych patient, sorry.
I've been treating patients who are under the watchful eyes of good
psychiatrists who watch them carefully when they are on these types of
medications. To me this isn't about the drugs, which usually save lives
not take them, it's about the management of the patient and poor
Actually it took Merck 4 years to pull Vioxx and they buried the first study that warned of problems.
therapydoc said: "...To me this isn't about the drugs, which usually
save lives not take them, it's about the management of the patient and
This is about the drugs, therapydoc, and it is also about the way that both the manufacturers and the drugs are controlled.
Can you honestly tell me that these things (SSRIs, for example)
work? How do you know that they work, and how do you know that they
work outside the acknowledged benefit of the placebo effect? I don't
believe that you can tell me that, any more than the MHRA could.
This whole business looks like a scam, where those in charge are
incapable of presenting the very information that should have been
established as a primary consideration. And this is done on the basis
that the information is proprietary, commercial data? Purr-lease.
"To me this isn't about the drugs, which usually save lives not take
them, it's about the management of the patient and poor history-taking."
I have always understood this website to be pro-patient and
pro-information. In light of that, I am appalled by your statement.
FYI, doc, "history-taking" is what slots people into DSM-dictated
boxes. Secondly, I'm a person, not a "patient" and I don't need to be
"managed." Thanks for your contribution, "therapydoc." Eli Lilly has a
website you might want to check out.
Word. And a cyber-bouquet for Franseca.
I agree with a lot of what you had to say on this topic. The media
should really step it up and bring more light to such issues on
reported adverse events. This, in turn, would increase public
awareness. However, I could not help but wonder if more media coverage
on these drug related deaths would ultimately lead patients to
experience feelings of betrayal and mistrust toward their health care
providers. In other words, patients being handed prescriptions will no
longer trust the doctors issuing them. This might even cause them to
avoid seeking treatment for their illness or deny drug therapy
altogether. It hurt me most to hear that “Risperdal, a drug associated
with over 1,000 deaths, is used in children--and the FDA approved its
use”. How can drugs such as this one, which is used to treat
schizophrenia, continue to be prescribed? It might be true that this
drug has helped many. But, the FDA has to ask itself the pressing
question: do the benefits outweigh the serious risks. I believe that
risks such as death and disability outweigh the benefits. More research
needs to be conducted on these drugs, in order to properly label all
the side effects and to determine whether it is best to simply take the
drugs off the market as was the case with Vioxx.