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Re: FDA warnings information

Posted by Sabina on February 4, 2005, at 0:31:04

In reply to Seroquel warning ?!, posted by banga on February 3, 2005, at 8:07:57

Here is a link to all 2004 FDA Safety Warnings for drugs:

http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#drugs

Seroquel is one of the many drugs on the list, outlining a potential "increased risk of hyperglycemia and diabetes" while taking the drug. And yes, Serzone is there, too! It's warning mentioned "hepatic failure" along with some other things. I didn't notice the words "black box" on this page, unless that is synonymous with Safety Alerts in FDA speak.

From what I understand, all AD's are now under the "black box" warning (as I believe med_empowered mentioned) passed last Fall by the FDA. That's the one that spoke primarily to the increased risk of suicide in children and adolescents:

http://pn.psychiatryonline.org/cgi/content/full/39/21/1

These newest potential Safety Alerts are, of course, in addition to whatever these drugs' *original* potential side effects were. In my experience, all drugs have scary potential side effects in the fine print. Have you heard some of warnings from certain commercials on TV? Good Lord, if our pdocs gave us that kind of sales pitch, we might all go home stunned and empty handed. The inserts on birth control pills scared me so that at one point (years ago, I'm off *all* hormonal BC now) I went to Depo Provera because I was told it was safer. Guess what's on the 2004 Safety Alert? By now I already have susbstantial bone density loss (in my mid 30's!) and directly link hormonal BC to my Fibromyalgia (FM) flare-up/breakdown in 2002 that exacerbated a chemical imbalance and left me searching for meds as a last resort.

For me (just me) Seroquel was literally a lifesaver and well worth the risk. Am I going to obsess about this newer warning? No. Not after all the work I did getting through the first year of worrying that I was going to develop glaucoma, which is listed on the product insert and runs in my family. Still seeing 20/20 today! We all know that these drugs come with a certain risk factor. What we have to do is sit ourselves down with our doctors and ask, Does the risk outweigh the alternative for us? Do we feel comfortable trying this drug and/or giving it some time to work? Though it was a long time ago, I vividly remember that I had a *hard* first couple of weeks with Seroquel.

Ironically, I was suicidal at the time I began taking Seroquel and finally felt kind of foolish realizing that, just as I began finding some relief with the drug, I was spending so much time worrying about maaaaaybee developing a treatable condition as a side effect when I didn't even know if I'd be around until next week or check out by my own hand! I'm only remembering laughing at myself, mind you, not inferring that worry over side effect profiles is foolish in itself or not to be respected.

There may well be "serious flaws" in the drug studies of Seroquel, but I like the pretty rocks balancing on their web site, so I figure they're okay by me. Nah, I'm just kind of getting at the fact that I could probably manage to find something negative about many of the most prescribed drugs mentioned on this site as well. I could probably even find a study promoting use of Seroquel for insomnia. Hmmm...hold on a minute.

Some boys in Gottingen did this:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15029469

But m*rde, I gotta tell you, I'd be kicking like a Rockette on crack with akathisia if I hit 100mg at one go on that stuff...even after all this time. On another personal note concerning letting myself be adversely affected by bad press, I've read some pur-etty creepy things (elsewhere) about some shady marketing and studies done of Neurontin; but somehow I'm still considering dumping my Topamax and giving it a try! I just can't stand the stupids anymore. I want to find out just how dumb I am au naturel because with the flippin' FM symptoms I can't tell which is which. Plus, I've lost over thirty pounds on that stuff! I need a change and Neurontin deserves a chance. Then again I don't know if they have cool rocks on their web site. Wait a sec...was there any mention of loss of common sense in those Seroquel studies? Aaaarrrrgh...save me, meds_empowered! OK, just checked...I do *not* dig their web site. My next choice was Gabitril. I wouldn't *really* choose a drug based on it's advert, but I sure does like the GABA. My first choice is actually to stop meds entirely, which I am seriously considering as well. I'm already tapering off the Topa, quite successfully, I might add.

To the first poster in this thread, I applaud you for being so proactive in your mother's care and I hope she's experiencing relief on her current sleep aid. Long term insomnia is one of the most maddening things I have ever experienced. It actually *makes* me hallucinate after a time when left un- or under-treated. I'll just be dozing off and think I hear the telephone ring or the front door slamming when I know I'm alone at home. I have to wait until the dog's lack of barking signals an all clear to let me know that Mama needs to get more sleep! I'd say it makes me nauseated and forgetful as well, but that could be the FM so who can say for sure. I'm *not* saying that your Mom presented with any other complaints, only that I deeply empathize with the physical and emotional distress caused my insomnia.

I know first hand that some docs and nursing homes hand out Seroquel like after dinner mints. Just because I'm a big foam finger fan of the drug doesn't mean that I think it should be in the town water supply, but perhaps your Mom's pdoc chose Seroquel over another sleep aid (for long term use?) as they feel it can also help with any confusion and depression that might be contributing factors to sleeplessness in the "getting older" populations. That's what I've been told, anyway. Just a thought to maybe redeem him somewhat in your eyes? Believe me, I balked a bit at first at the term "atypical antipsychotic" myself, so I understand your anger. And I know nothing about your mother's age or situation, so please don't allow my ill informed comments step on your toes. It's just that I'm "not schizophrenic or anything like that" either, but it was still a good fit for me.

Mostly, I just wanted to pop in and give the links above to clear things up as to the Serzone/Seroquel, "black box" vs. Safety Alerts List. Then I just kept rambling. Sorry.

I was getting distracted anyway. Gotta go pay attention to Lars von Trier's The Kingdom on IFC now. http://www.amazon.com/exec/obidos/ASIN/6304018959/drbobsvirte00-20 I own it but I still like to watch it when it's on. Cheers.



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