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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 9 of 9. This is the beginning of the thread.
Posted by Tony C. on August 18, 2004, at 11:43:25
July 20, 2004
FDA ALLOWS GENERIC SERZONE TO REMAIN ON THE MARKET
The FDA has denied a citizen petition calling for the removal of Bristol-Myers Squibb's (BMS') antidepressant Serzone because of safety concerns — a move that allows generic firms to continue to market the drug, which no longer is sold by BMS.
BMS announced this spring it would stop marketing Serzone (nefazodone HCl) June 14 because generic versions are widely available and brand sales have rapidly declined. Several patient advocacy groups, however, have urged the FDA to remove all nefazodone products from the market because the drug has been associated with cases of serious liver toxicity.
The FDA, however, does not agree that the available evidence shows the drug is unsafe under approved conditions of use, the agency said in a response to a March 6, 2003, petition by the Public Citizen Health Research Group. "[The] agency continues to believe that nefazodone provides a potentially important alternative to other antidepressants and that, although there is a risk of liver injury associated with the drug, the incidence of liver failure appears to be low and is adequately addressed through product labeling," the FDA said in a recent letter linked to the agency's website.
Serzone has been associated with 94 cases of liver injury between December 1994 and May 2003, according to Public Citizen Health Research Group.
(NOW I DON'T FEEL SO ANXIETY RIDDEN OVER IF THEY ARE GOING TO BAN IT, I STILL WANT TO REDUCE, BUT THIS CALMS ME ALOT TO KNOW IT WAS NOT BANNED !!! HIP HIP HOORAY !!!)SINCERELY - HAPPY TONY C. ; )
Posted by woolav on August 18, 2004, at 12:41:46
In reply to THANK YOU FDA !!! FROM ALL SERZONE GENERIC USERS, posted by Tony C. on August 18, 2004, at 11:43:25
Im glad your happy Tony, but make sure that you are having your bloodwork done for your liver. I took serzone and had a good response also, but my pdoc said it wasnt worth it and changed me to celexa at the time....
S
Posted by Tony C. on August 18, 2004, at 17:11:03
In reply to Re: THANK YOU FDA !!! FROM ALL SERZONE GENERIC USERS, posted by woolav on August 18, 2004, at 12:41:46
Hi, How long were you on Serzone, at what dosage, and how was your Transition to Celexa ?
Please let me know ASAP
Thank you !!!
Tony C.
Posted by HappyGirl on August 18, 2004, at 23:35:57
In reply to THANK YOU FDA !!! FROM ALL SERZONE GENERIC USERS, posted by Tony C. on August 18, 2004, at 11:43:25
Hi Tony C.:
Thanks for 'Update' regarding Nefadozone/Serzone.Currently, I do NOT worry about Nefadozone's future, because it JUST arrived on the shelf NOT long ago, ... less than two years or so. But, we, long-term Nefadozone/Serzone users have a GREAT concern over FDA's decision. In my guess, ... it/Nefadozone will stay on the market for unlimited time UNLESS someone goes to the court for asking money on his/her 'unhappiness' on Nefadozone.
H.G.
Posted by woolav on August 19, 2004, at 9:32:19
In reply to Re: THANK YOU FDA !!! FROM ALL SERZONE GENERIC USERS, posted by HappyGirl on August 18, 2004, at 23:35:57
I dont remember what dose i was on. But i took it for about a year. And really liked the results (for my depression). it may have been 40mg, but i really cant recall...I didnt have any probs switching to celexa. (maybe i am lucky, i didnt even have problems getting off effexor) I thought that lexapro, is a new drug that combines celexa and prozac together. That could be a good option too..
S
Posted by cpallen79 on August 19, 2004, at 14:51:20
In reply to Re: THANK YOU FDA !!! tony, posted by woolav on August 19, 2004, at 9:32:19
How well Does Serzone work for panic/anxiety?
Any thoughts on this??
> I dont remember what dose i was on. But i took it for about a year. And really liked the results (for my depression). it may have been 40mg, but i really cant recall...I didnt have any probs switching to celexa. (maybe i am lucky, i didnt even have problems getting off effexor) I thought that lexapro, is a new drug that combines celexa and prozac together. That could be a good option too..
> S
Posted by cpallen79 on August 19, 2004, at 16:24:41
In reply to THANK YOU FDA !!! FROM ALL SERZONE GENERIC USERS, posted by Tony C. on August 18, 2004, at 11:43:25
Tony, where did you get this information? I have a friend wanting to take Serzone but he's heard that it was banned completely. can you elaborate? Thanks
> July 20, 2004
>
>
> FDA ALLOWS GENERIC SERZONE TO REMAIN ON THE MARKET
>
> The FDA has denied a citizen petition calling for the removal of Bristol-Myers Squibb's (BMS') antidepressant Serzone because of safety concerns — a move that allows generic firms to continue to market the drug, which no longer is sold by BMS.
>
> BMS announced this spring it would stop marketing Serzone (nefazodone HCl) June 14 because generic versions are widely available and brand sales have rapidly declined. Several patient advocacy groups, however, have urged the FDA to remove all nefazodone products from the market because the drug has been associated with cases of serious liver toxicity.
>
> The FDA, however, does not agree that the available evidence shows the drug is unsafe under approved conditions of use, the agency said in a response to a March 6, 2003, petition by the Public Citizen Health Research Group. "[The] agency continues to believe that nefazodone provides a potentially important alternative to other antidepressants and that, although there is a risk of liver injury associated with the drug, the incidence of liver failure appears to be low and is adequately addressed through product labeling," the FDA said in a recent letter linked to the agency's website.
>
> Serzone has been associated with 94 cases of liver injury between December 1994 and May 2003, according to Public Citizen Health Research Group.
>
>
> (NOW I DON'T FEEL SO ANXIETY RIDDEN OVER IF THEY ARE GOING TO BAN IT, I STILL WANT TO REDUCE, BUT THIS CALMS ME ALOT TO KNOW IT WAS NOT BANNED !!! HIP HIP HOORAY !!!)
>
> SINCERELY - HAPPY TONY C. ; )
>
>
>
Posted by Tony C. on August 20, 2004, at 19:36:23
In reply to Re: THANK YOU FDA !!! FROM ALL SERZONE GENERIC USERS » Tony C., posted by cpallen79 on August 19, 2004, at 16:24:41
Hi, it was VOLUNTARILY recalled from BMS in the USA only because 8 Generic Companies make it, which the Serzone is called NEFAZODONE - It works the same, it is great for Anxiety and Sleep Related insomnia, and does not make you drowsy like Trazodone, I PROMISE you in the USA Generic Serzone called ---> Nefazodone is on the shelves, and NOT Banned, the FDA feels it can be managed with Doctors knowing of Liver risk, which is very remote. I am Glad, I almost felt suicidal fearing all summer they were going to ban it in the USA, thank goodness they did not, I just called BMS yesterday, and they said it is available as NEFAZODONE the same thing as the Serzone. A very good med for me. They also said there have been no liver Deaths since Dec. 2001 when the Black Box warning came out and people getting liver blood tests.
I worked hard to beg them not to ban it, I think some others did on here also, if I am on this for life, I want it available to me.
Sincerely - Tony C.
Posted by HappyGirl on August 21, 2004, at 0:26:46
In reply to Re: SERZONE BANNED IN CANADA NOT THE USA CPALLEN, posted by Tony C. on August 20, 2004, at 19:36:23
Hi Tony C.:
I totall agree with you regarding the Nefadozone's good/terrific effectiveness on both, Depression and Anxiety.For the past two weeks on the Trazodone regimen upon my pdoc.'s advice (from 75 mg. to 150 mg.), I went to just one pill of Nefadozone, 150 mg. from three pills of Nefadozone, 450 mg. However, my depression returned along with a bit of 'Anxiety' moods. Afterwards, I truly realized I needed 'two' pills of Nefadozne, 300 mg.
In my personal experience, the Trazodone 150 mg. is 'magic' during sleep, ... but seems LESS effectiveness on Depression and Anxiety areas. In this respect, Nefadozone is MUCH better and first of all, ... very smoother effectivenss in comparison with Trazodone. Besides this, you already knew about Trazodone, upon swallowing the Traz., it's pretty 'discomfort' due to the size with rough edges unlike the Nefadozone which is smaller and rounder.
As said the above, ... in my case, I can NEVER afford to 'lose' this 'miracle' med., Nefadozone. I, too will fight to NOT 'ban' Nefadozone.
H.G.
This is the end of the thread.
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