Furious Seasons

February 03, 2009

Adverse Event Report Filed About Seroquel

Yesterday I filed an adverse event report with the FDA related to my 14 month use of the atypical antipsychotic Seroquel. Here's what I told the FDA:

"I began taking Seroquel at 25 mgs. a day in April 2004 for bipolar disorder/depression. I developed rapid weight gain from approximately 220 pounds to 245 pounds. I experienced muscle tightening in my legs and back, muscle tears in my right deltoid, back pain and severe nightmares. I had no history of muscle problems and nightmares before taking this drug. I also experienced jerking and convulsions in my legs and right arm, especially when at rest. I had no prior history of this before taking this drug. In addition, in May 2005 I experienced tardive dysknisia as a result of taking this drug. My lips began trembling and my mouth began moving. This was observed by work colleagues and reported to me. I stopped taking the drug soon after. I still experience jerking and convulsions in my legs and right arm. I have been diagnosed by a physician with sleep tremors and chronic back pain as a result of taking this drug. I have been unable to date to lose the weight I put on while taking this drug, despite careful attention to diet."

I've written about damage caused by Seroquel before. I could've filed this report long ago, but held off until being examined by a physician. I also checked the box on the FDA's form that reveals my identify to AstraZeneca, the drug's maker. How much do you want to bet that they don't have the guts to contact me?

Then again, you do have to wonder about the value of filing such reports. I fear that reports like mine go into a memory hole at the FDA and no one at the agency reviews them.

Ugh, I need to go lose some weight. At six-foot-two, I carry it OK and am at about 230 pounds now, but I'm simply tired of it. I'd really like to get back down to 200 pounds or so (I've always run bigger than the BMI for my height due to many years of weightlifting and competitive sports). First, though, I need to get my back fixed. Thanks, Seroquel!

Posted by Philip Dawdy at February 3, 2009 12:38 PM

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Comments

Good for you, phil. At the very least, quarterly reports are filed and trends are noted, if not by FDA by others. I filed for Lamictel and suicidality and FDA told me to contact (Wyeth?) Wyeth, with no comment, sent me a questionnaire which I'm sure went in the shredder when they got it back. Should have sued the ********. (just an idea for you). Also this is an idea for a story, either written by you or an as-told-to.

Posted by: ebliversidge@earthlink.net at February 3, 2009 12:56 PM

Good on ye, Philip.
S.

Posted by: Sherry at February 3, 2009 01:17 PM

I took Seroquel for three years for bipolar disorder, and in that time gained 100 lbs, which I drove myself crazy trying to lose. Ultimately, in June 2007, I had a roux-n-y gastric bypass which has enabled me to lose 126 lbs. Needless to say, I no longer take Seroquel. I also had the jerks and tremors, and still have the jerking at times. Horrid drug. Unfortunately, I go right into a mixed episode without an AAP, but so far Risperdal seems to be working ok at a low dose. However, I live in fear every day of gaining the weight back (which is a good thing, it keeps me on my toes) due to my AAP use. I wonder if I too should file a report?

Posted by: NurseExec at February 3, 2009 01:56 PM

Hi Phil,
My hubby and I joined Weight Watchers together. It does work...and we have never felt deprived.

On psych drugs and Seroquel. I only took Seroquel as an anti-anxiety agent. I can not phantom taking it everyday. There were several factors leading up to my weaning off of pysch-meds, but going to a new doc who wanted to put me on Seroquel when I was having no symptoms was certainly the tipping point for me. I am glad I never took it regularly.

Posted by: Naturalgal at February 4, 2009 05:52 AM

I've filed adverse event reports with the FDA/Medwatch, both as a prescriber and as a patient. And the manufacturer has always contacted me.
I should add that I've filed my "patient" reports using a different first name (I go by a nickname) and address, mainly out of curiosity as to what their response would be.... and some using my "work" name and address. I've seen no difference between the responses.

Good luck. Thanks for filing. Feedback is helpful, even if it is to a flawed system.

Posted by: Ellie at February 5, 2009 10:20 PM

philip, that's too bad you've "been unable to date". smart guy like you, you're quite the catch! ;)

Philip Dawdy responds: i didn't say anything about not being able to date.

Posted by: anon mom at February 9, 2009 01:12 PM

I have a love/hate relationship with Seroquel. The drug I had "trouble" with was Klonopin. The docs couldn't figure out that I was having tolerance withdrawal so they called me somatic and gave me Seroquel. Later, after I got off of all meds including Klonopin, I went four years trying to live and work while suffering with chronic insomnia. I mean, it was absolutely HORRIBLE. I finally caved, got back into the system and asked for Seroquel. It's been the lesser of two evils, at least so far. I got off of it about a year later, and about six months after that hit an insomnia wall again. Sorry to post a long story. I'm grateful for Seroquel. (Although had they not taken the old Actifed off the market, I could have kept using that.)

Posted by: Laura at May 15, 2009 07:22 AM