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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 25 of 29. This is the beginning of the thread.
Posted by kw on January 23, 2004, at 5:54:31
Depression pill removal to affect thousands
By Julie Robotham, Medical Editor and agencies
January 23 2004
Thousands of Australians with mood disorders will be forced to switch to another antidepressant or cease medication altogether after the manufacturer of Serzone decided to take it off the market from May.The chairman of the Royal Australian and New Zealand College of Psychiatrists' committee for psychotropic drugs, Bill Lyndon, said the transition might prove difficult for some patients.
Dr Lyndon said this was because Serzone, which has been linked to rare but potentially fatal liver damage, caused fewer sleep and sexual problems than other drugs.
He said Serzone, which is made by Bristol-Myers Squibb, might be the only medication that worked for some people.
"It's disappointing to lose a drug which does help some people," he said. "The bigger the variety, the better off people are."
But most patients would "be able to transfer uneventfully" to a different medication, Dr Lyndon said, and the college would not be asking the Federal Government to treat Serzone as an "essential drug", a category that can make a drug available under special provisions after a manufacturer stops selling it.
Serzone continues to be available in the US, where it is widely used especially in geriatric patients, despite being linked to 55 cases of liver failure, including 20 deaths, since 1994.
The decision to withdraw Serzone comes amid mounting concern worldwide about the side effects of antidepressants.
The clinical adviser to the depression initiative beyondblue, Ian Hickie, said a small minority of patients would be at risk of a relapse of the condition. But most of those whose depression had stabilised while on Serzone would be able to find another drug that worked for them.
"Doctors need to take the opportunity of looking at whether people need to be on medication at all," Professor Hickie said.
Some people remained on antidepressants indefinitely, he said, when doctors should try to wean patients off drugs and offer them psychological treatments instead.
Bristol-Myers Squibb issued a statement saying it would no longer market Serzone in Australia, "because of its current low and declining rate of use". The company has already withdrawn Serzone in Europe, citing the same reasons. But in Canada, health regulators banned its use.
Australia's Therapeutic Goods Administration is reviewing the safety of the widely used selective serotonin reuptake inhibitor (SSRI) class of antidepressants in children and adolescents.
The review follows advice from the British Government that only Prozac should be used by under-18s because other drugs might make them agitated or suicidal. A similar review is under way in the US.
But yesterday, psychiatrists from the American College of Neuropsychopharmacology defended the use of mood-altering medicines in children.
The college said there there was no strong evidence the medicines increased suicide risk.
J. John Mann, a Columbia University professor of psychiatry and co-chairman of a college task force addressing the controversy, said: "Depression in children and adults is the major illness that underlies suicide, and we believe that the SSRI class represents the medication with the greatest efficacy against this very serious condition."
sydney morning herald
Posted by Sad Panda on January 23, 2004, at 8:27:49
In reply to serzone banned in aust, posted by kw on January 23, 2004, at 5:54:31
Well there is one I won't get to try. :/
"Australia's Therapeutic Goods Administration is reviewing the safety of the widely used selective serotonin reuptake inhibitor (SSRI) class of antidepressants in children and adolescents. The review follows advice from the British Government that only Prozac should be used by under-18s because other drugs might make them agitated or suicidal. A similar review is under way in the US."
Only Prozac is safe for childeren?!? I thought Zoloft was the safest of SSRI's & the preffered one for children? Prozac was the 1st drug my GP gave me to try, it gave me extreme agitation & bad nightmares.
Cheers,
Panda.
Posted by PoohBear on January 23, 2004, at 14:02:30
In reply to serzone banned in aust, posted by kw on January 23, 2004, at 5:54:31
Well, there ya go:
That's the glory of socialized medicine for ya...
Nothin' like the government tell you which medications you can and cannot have. Despite our problems, I'm glad I live here in the USA.
TR
Posted by HappyGirl on January 23, 2004, at 14:24:40
In reply to serzone banned in aust, posted by kw on January 23, 2004, at 5:54:31
Hi:
There is a gereic form 'Nefadozone' came to the market around the last part of last year, 2003, ... from the reading. This med. Serzone might have some potential bad-side effect just VERY *few* people, ... but those 'consumer Advocate/group' including FDA does NOT pay attention to those who need Serzone. Some of folks are intolerable to many of ADs, then Serzone was rxed, for this reason, Serzone/Nefadozone is VERY crucial to those who depend on Serzone. However, rather than paying attention to M.I. folks, ... they keep ditching just 'BAD side' from Serzone.
There, even here in USA, still some 'topic' of trying to 'discontinue' Serzone by telling *ONLY* 'bad story' to FDA, ... then there may have a 'threat' among those who need this med, Serzone as having read at 'NIH'site or somewhere Internet.
H.G.
Posted by kw on January 23, 2004, at 19:31:34
In reply to Re: serzone banned in aust, posted by PoohBear on January 23, 2004, at 14:02:30
To be fair, it wasn't the Australian govt that took the decision.The company that makes it withdrew it from the market, partly due to declining sales.
> Well, there ya go:
>
> That's the glory of socialized medicine for ya...
>
> Nothin' like the government tell you which medications you can and cannot have. Despite our problems, I'm glad I live here in the USA.
>
> TR
Posted by PoohBear on January 23, 2004, at 20:04:14
In reply to Re: serzone banned in aust, posted by kw on January 23, 2004, at 19:31:34
at socialized medicine, but the manufacturer withdrawing the product voluntarily wouldn't have been the first thing to cross my mind.
Kindest Regards,
Tony
Posted by HappyGirl on January 24, 2004, at 14:11:51
In reply to serzone banned in aust, posted by kw on January 23, 2004, at 5:54:31
Hi:
My dear friend who is temporary working in Canada said that NO AD Med. like 'Serzone,' because Serzone is VERY unique component that even any psycho.expert does not know how this med. working on the chemical of the brain. Not like SSRIs, ... Serzone is so independent class of AD med. that there is/are NO substitute AD for this med., unfortunately, ... this is from my dear friend's quote. He was placed other two or three different AD meds., but his Depression are progressing due to the lack of Serzone effect. It's VERY sad for me to hear that!Then, it must be quite disappoint to see if Serzone would discontinue here, in USA, as seeing my dear friend will be here in the near future. Trazodone is very similar to Serzone in regard to the component, however there is still difference between two med. as to the effective/working on individual cases.
Besides this, in regard to 'Liver' issue is to be also 'case by case,' because most of pdocs. informed their patients in regard to 'Black Box' upon his/her rx.
As having said this above, if there is/are 'liver issue' before or after taking this med., those who taking Serzone should report their pdocs. IMMEDIATELY on their pdocs.'s instruction.
In my guess, ... Serzone may/will survive here, in USA despite those 'Consumers' Advocate's interruption,' ... however there is still 'rough road' to keep this med. in 'quiet place.' It might be always on-going issue as to 'Liver Issue,'(those lawyers LOVE IT!) ... not *EFFECTIVENESS/GOOD* side of the Serzone issue.
A person like my dear friend who needs this med., Serzone has to suffer from this, because of the *NON-M.I./NON-knowledgeable* Serzone users's interruption.
H.G.
Posted by HappyGirl on January 26, 2004, at 14:00:14
In reply to *NO* Alternative to Serzone?, posted by HappyGirl on January 24, 2004, at 14:11:51
To Serzone Takers:
I contacted personally to the maker, Bristol-Myers Squibb as to whether Serzone keeps here, in USA, by e-mail.
I received the following from Bristol-Myers Squibb by e-mail, right after I e-mailed to them:>>> Serzone has been discontinued in Europe. We have no plans to
discontinue product in the United States.<<<
H.G.
Posted by noa on January 31, 2004, at 13:33:43
In reply to *NO* Discontinuation of Serzone, in USA, posted by HappyGirl on January 26, 2004, at 14:00:14
Thank goodness. Serzone is a very important component of this carefully balanced cocktail I'm on. My pdoc tells me that the liver danger--a very serious one, but a very rare one--would show up pretty much right away if it is going to at all.
I've been taking Serzone for years. I get my liver enzymes tested regularly--I would anyway because of the other meds I'm on--and they've been fine.
Posted by rvanson on February 2, 2004, at 0:31:18
In reply to Re: serzone banned in aust, posted by PoohBear on January 23, 2004, at 14:02:30
> Well, there ya go:
>
> That's the glory of socialized medicine for ya...
>
> Nothin' like the government tell you which medications you can and cannot have. Despite our problems, I'm glad I live here in the USA.
>
> TR
The FDA has routinely not permitted safe A/D medications approved in other countries to be prescribed by US doctors.A good example is Moclobimide (Aurorix)readily available in Austrailia, the UK and Canada, but not the USA.
Posted by Rick on February 3, 2004, at 19:38:32
In reply to Re: serzone banned in aust, posted by rvanson on February 2, 2004, at 0:31:18
> > Well, there ya go:
> >
> > That's the glory of socialized medicine for ya...
> >
> > Nothin' like the government tell you which medications you can and cannot have. Despite our problems, I'm glad I live here in the USA.
> >
> > TR
>
>
> The FDA has routinely not permitted safe A/D medications approved in other countries to be prescribed by US doctors.
>
> A good example is Moclobimide (Aurorix)readily available in Austrailia, the UK and Canada, but not the USA.
>
What you describe does indeed happen, but it's also partly up to the manufacturer sometimes. In some cases the manufacturer decides there's not enough economic payoff to warrant seeking U.S. approval, especially if they've failed to show efficacy (or have shown some potentially dangerous side effect) in initial U.S. tests.I recall reading that just a year or two ago Roche wanted to get approval for moclobemide in the U.S. for Social Phobia, but abandonded this effort when some placebo-controlled tests failed to demonstrate efficacy. Roche could have gone "back to the drawing board" and re-tested (as Somerset is doing with the selegiline patch) but apparently concluded that it wouldn't pay off economically.
Another drug available elsewhere but for which the manufacturer abandonded securing FDA approval was reboxetine. The circumstances were very similar to those for moclobemide, although the approval was being sought for depression rather than social phobia.
What's sad is that even a med which fails a placebo-controlled test could in reality be very helpful for *some* people. Also, a high placebo response rate screws things for some drugs which are actually quite effective. Heck, there have been some recent double-blind, placebo-controlled tests for old standby Prozac in which it failed to outperform the placebo!
I don't claim to know this for a fact, but I suspect the FDA may have a more rigorous (and expensive) new-drug approval process than other countries.
Rick
Posted by Rick on February 3, 2004, at 19:48:24
In reply to *NO* Alternative to Serzone?, posted by HappyGirl on January 24, 2004, at 14:11:51
> Hi:
> My dear friend who is temporary working in Canada said that NO AD Med. like 'Serzone,' because Serzone is VERY unique component that even any psycho.expert does not know how this med. working on the chemical of the brain. Not like SSRIs, ... Serzone is so independent class of AD med. that there is/are NO substitute AD for this med., unfortunately, ... this is from my dear friend's quote. He was placed other two or three different AD meds., but his Depression are progressing due to the lack of Serzone effect. It's VERY sad for me to hear that!
>
> Then, it must be quite disappoint to see if Serzone would discontinue here, in USA, as seeing my dear friend will be here in the near future. Trazodone is very similar to Serzone in regard to the component, however there is still difference between two med. as to the effective/working on individual cases.
>
> Besides this, in regard to 'Liver' issue is to be also 'case by case,' because most of pdocs. informed their patients in regard to 'Black Box' upon his/her rx.
> As having said this above, if there is/are 'liver issue' before or after taking this med., those who taking Serzone should report their pdocs. IMMEDIATELY on their pdocs.'s instruction.
> In my guess, ... Serzone may/will survive here, in USA despite those 'Consumers' Advocate's interruption,' ... however there is still 'rough road' to keep this med. in 'quiet place.' It might be always on-going issue as to 'Liver Issue,'(those lawyers LOVE IT!) ... not *EFFECTIVENESS/GOOD* side of the Serzone issue.
>
> A person like my dear friend who needs this med., Serzone has to suffer from this, because of the *NON-M.I./NON-knowledgeable* Serzone users's interruption.
> H.G.You're right...it's sad, and it's preposterous. I have a friend for whom Serzone works wonders (on his GAD) and also just happens to normalize his high blood pressure better than his blood pressure meds.
Despite what Bristol-Myers says (acoording to another poster), I wouldn't be too surprised to see it get the boot in the U.S., too. Certainly the manufacturer is not going to spend a bundle defending a drug which is now off-patent (and always had a fairly low share among AD's anyway).
Posted by Rick on February 3, 2004, at 19:52:25
In reply to Re: serzone banned in aust, posted by kw on January 23, 2004, at 19:31:34
>
> To be fair, it wasn't the Australian govt that took the decision.Good point, but there may have been some direct or indirect pressure, i.e., the manufacturer "saw the writing on the wall" after the overblown liver scare. (I don't mean to diminish the graveness of the situation for the tiny proportion of users who suffered liver damage...but it *was* a tiny proportion).
Posted by HappyGirl on February 5, 2004, at 8:53:31
In reply to Re: *NO* Alternative to Serzone? » HappyGirl, posted by Rick on February 3, 2004, at 19:48:24
Hi Rick:
Your 'Realistic' and 'Practical' prediction on Serzone issue is quite true. I totally agree with you every words/spelling you're describing, here, above.
My worry/concern on this med., Serzone is quite 'high,' however, because Serzone is only one med. my dear person taking and working GREAT on his depression along with Anxiety. Without Serzone, he must be disasterous! For this, I've been thinking of whether this group(consumer advocate) keeps fighting to destroy someone's happiness by neglecting to look at other 'GOOD side,' the TREMENDOUS effectiveness some of M.I. getting. Hence, we need to bring up this 'issue' once awhile to show 'how effective Serzone/Nefadozone some of M.I. receiving,' ... not keep digging for 'liver-issue.' I know, in my core heart/mind, ... those Consumer Group along with FDA are more powerful than the maker, Bristo-Myers Squibb as seeing a generic form of Serzone, Nefazone is already in the market. But, we, some of consumers have also every right to speak up for Serzone, because those who taking Serzone knows much more than those folks, 'Consumer Advocate' and 'FDA.'
Lastly, in my very hope, NO past/present Serzone takers trying to 'sue' over Serzone. Also, in my knowledge from a dear friend,... upon prescription, there is a stern warning, 'Black-Box' warning to discontinue Serzone once there is/are suspicious symptoms would develop during Serzone treatment. So, why in the heck, some of folks trying to 'sue' over Serzone?
H.G.
Posted by Chairman_MAO on February 7, 2004, at 9:33:53
In reply to *NO* Alternative to Serzone?, posted by HappyGirl on January 24, 2004, at 14:11:51
Closest alternative I could think of:
300-400mg trazodone/day in divided doses + 150-225mg Effexor
If your friend can survive the sedation, the effect very well may be quite similar. IMHO, the hysteria over Serzone is unfounded. The risk of liver failure is 1:1000 and can be avoided with monitoring. The combination above is likely not an EXACT substitute by any means, as Serzone is the only 5ht2a antagonist on the market (that I can think of) with no significant antihistamine effect.
Posted by HappyGirl on February 7, 2004, at 12:53:13
In reply to Re: *NO* Alternative to Serzone? » HappyGirl, posted by Chairman_MAO on February 7, 2004, at 9:33:53
Hi:
Thanks for your suggestion along with VERY informative information on both, Serzone Hyper over Liver Issue and the Substance/component of Serzone.
Effexor about which you're suggesting, my dear one actually took just in front of ME, ... then I witnessed with my 'very' eyes, he started 'convultion' along with 'rapid heart rate' that almost needed to call '9ll.' It was very scary!!! I just held him very tight NOT to pass-out on the kitchen/hard floor. After about a half hours later, he regained his composure, ... but with only *75 mg.* Effexor. Just, ... he can not take any of SSRI. Before, he was on Zoloft that almost sent him over the tall bridge for his own infliction.
Serzone, ... he never chose to take, ... but practically he's NOT able to take any of SSRIs and probably other ADs as well. Very disappointing to see him not to able to take those 'up-to-date' ADs, ... but nothing I can do on this.
Thanks for your suggestion along with a good education provided.
H.G.
Posted by Rick on February 7, 2004, at 23:13:26
In reply to Re: *NO* Alternative to Serzone? » HappyGirl, posted by Chairman_MAO on February 7, 2004, at 9:33:53
>The risk of liver failure is 1:1000 and can be avoided with monitoring.
Actually, I believe the risk of liver failure with Serzone is a lot lower than that. According to the Wall Street Journal, 1 out of every 250,000 to 300,000 people taking Serzone will develop liver failure. If it were 1 in 1000, I'm sure the FDA would take it off the market.
Posted by Chairman_MAO on February 8, 2004, at 8:33:12
In reply to Re: *NO* Alternative to Serzone? » Chairman_MAO, posted by Rick on February 7, 2004, at 23:13:26
>Actually, I believe the risk of liver failure with Serzone is a lot lower than that. According to the Wall Street Journal, 1 out of every 250,000 to 300,000 people taking Serzone will develop liver failure. If it were 1 in 1000, I'm sure the FDA would take it off the market.
You're right. I don't know where in my mind I pulled that figure out, but it's incorrect. The 250,000 to 300,000 is, according to the monograph, "patient-years", not people, though.
I stand admonished,
--cm
Posted by aussie on February 9, 2004, at 0:34:07
In reply to Re: serzone banned in aust, posted by kw on January 23, 2004, at 19:31:34
I'm an Aussie but I live here in CA. I tried to get off Serzone but it made me crazy (upset)when I tried last time. Glad I'm not in Australia now. I'm ramping up on Effexor so I can get off Serzone. 'Course then I read all these awful things about coming off Effexor(eventually). Kind of depressing really. (sarcasm)
Posted by HappyGirl on February 9, 2004, at 13:39:54
In reply to Re: serzone banned in aust » kw, posted by aussie on February 9, 2004, at 0:34:07
Hi:
In my knowledge, if you've been on Serzone for Depression with some 'Anxiety' purpose, ... it might be NOT easy to get off Serzone. Because, Serzone has dual property, Depression and Anxiety effect. For that reason, most of pdoc. advises to take Serzone before going to the bed. at least one dosage among three,... even 'sleep-well' purpose.
In replacement for Serzone, just only AD such as your case, 'Effexor' alone regimen might pop- up 'Anxiety' side of depression, or insomnia problem would arise. At least, this is my personal observation/knowledge on my dear person.
Then, if you want to get off Serzone COMPLETELY, you need two meds. not only AD, Effexor but one more med. for Anxiety.
H.G.
Posted by aussie on February 9, 2004, at 23:53:30
In reply to Re: serzone banned in aust, posted by HappyGirl on February 9, 2004, at 13:39:54
Dear Happy Girl,
I've been slowly adding Topomax. Tingly fingers, out of breath when I excercise, and can't think of the right words are my side effects occasionally. I feel like a loser being on THREE drugs but I do want to get off the serzone, however afraid I am to doit. :(
Posted by HappyGirl on February 10, 2004, at 0:19:11
In reply to Re: serzone banned in aust » HappyGirl, posted by aussie on February 9, 2004, at 23:53:30
Hi:
I heard/read that Topamax is a good 'add-on' med. for Bipolar med.(mood-stabilizer) and also on the weight issue developed due to some other psycho. meds. However, cognitive problem, such as forgetting 'right words' to say before and after, then some of folks feels 'odd' to be around normal adults. That I read/heard, ... then you might be expereincing similar episodes to those side-effects from Topamax.
In my suggestion, as someone suggesting a day or two before, ... Trazodone is a good med., even someone saying 'sister-med.' to Serzone.
I too agree with you in regard to 'too many med.,' in that respect, ... Serzone has 'two' efficacy, for depression(a kind, a milder form of AD, but enough to take care of ... ) and Anxiety(due to sleep-well med.).
In my suggestion, if you are happy about Serzone, keep taking this med. As long as you reside here, in USA, there must be NO problem to get Serzone.
H.G.
Posted by aussie on February 10, 2004, at 0:58:10
In reply to Re: serzone banned in aust, posted by HappyGirl on February 10, 2004, at 0:19:11
Dear Happy Girl,
that's just it,I want to get off serzone because 1. the top dose 600 'didn't do it for me'.
2. It's may notbe good fortheliver.
I'm hoping that Effexor and Topomax will 'do it for me'.
How come you are so happy?Am I the only one on the west coast?
Posted by Rick on February 10, 2004, at 11:15:03
In reply to Re: serzone banned in aust » HappyGirl, posted by aussie on February 9, 2004, at 23:53:30
> I feel like a loser being on THREE drugs but I do want to get off the serzone, however afraid I am to doit. :(
There is no reason whatsoever that being on three drugs should make you feel like a "loser", unless you're talking losing money! There are millions of people in this country alone who end up on multiple meds, both for psychiatric and other disorders -- and are doing just fine, thank you! And that doesn't necessarily indicate that they are any "sicker" than people who take just one drug -- just that their body chemistry is a bit different in some ways. (Besides, even when someone *is* "sicker", that doesn't make them a "loser"!)
Serzone usually isn't hard to get off, but some people have reported trouble. (And at the risk of sounding like a broken record, that doesn't make you a "loser" either!) It sounds like you need to wean off slowly. Based on this experience, it sounds as if you may want to avoid Paxil and Effexor (sorry, I forget if you've already considered or tried one of these).
Just work with your doctor(s). I know it's frustrating, but eventually you'll get there.
And re your question about no one on the board living on the west coast, what makes you think that? I don't, but I've seen many posting here who say they live in L.A. and other west coast cities.
One more thing...I repeat what I and others have said: The risk of liver damage with Serzone is truly minimal. You'll have a lot more risk crossing the street or drinking too heavily. The difference is that in those very rare occasions where there *are* problems with Serzone and the liver, it can be very grave. That's why doctors are afraid of it (think "malpractice" and ambulance chasers and the legal leeches that abound in net ads.) The more legitimate concern is that Serzone can have strong metabolic interactions with some drugs. As an anecdotal experience, when I took it (over two years), I was also taking several drugs it interacted with. My liver function tests came out better than ever when I was on Serzone. I was taking 450 mg, and several times tapered off over a period of two days, with no problems.
Rick
Posted by HappyGirl on February 10, 2004, at 13:49:49
In reply to Re: serzone banned in aust » HappyGirl, posted by aussie on February 10, 2004, at 0:58:10
Hi aussie:
I too know that Serzone is a kind, milder AD med., especially in comparison to those SSRIs, like Zoloft, Paxil and more to say.
The 600 mg. Serzone is also 'Maximum dosage,' then your worry/concern is understandable. In my guess, the more Serzone you get, the more Side-effect(liver issue) might develop, ... however, to be frank and honest, I can NOT be sure for this area/more information might be needed.
Then, you are on Effexor and Topamax with tapering off Serzone very slowly,... in my guessing. However, your 'Anxiety' side of depression sounds like asking a more proper med.
As I said in my previous post, Topamax is to be rxed for 'add-on' to mood-stabilizer, but it could be used for Depression/Anxiety. For this, have you ever thought about some milder AP, like 'Seroquel?' On Minimum dosage of the Seroquel, many of M.I. get satisfactory result,... but again, this med. might NOT be in your case, because your Anxiety is NOT too grave to need this form of AP med.
First, try to talk to your pdoc. soon.
BTW, in regard to 'Liver issue' is not only on Serzone. In my knowledge, even Depakote(mood-stabilzer for BP) has 'pancreatic issue.' Also, Zyprexa has 'Diabetic issue.' ... then if you're too concerned about all those 'Press,' there is NOT too many meds. to choose and take. When you're in emotionally and mentally havoc due to depression or any other M.I., the very first thing in your mind is a desire to get/feel well at the earliest possible, ... not want to wait 'too long' to get back to 'old yourself.
H.G.
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Dr. Bob is Robert Hsiung, MD,
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