Long-Term Safety of Seroquel
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Q:  Long-Term Safety of Seroquel

My Bipolar 18 year old son has been treated successfully since April 2000 with Seroquel,  and he is now doing well in college. We would like him to stay on Seroquel at least through college (he was so manic before, he was failing high school and in and out of juvenile hall, desoite other treatments Depakote etc.) What evidence is there that Seroquel is safe for longterm treatment? He is on 200 mg pm and 50 mgs am. I know its new, but what is the longest term studies done?

Dear Ms. K' -- 
Seroquel is gaining favor in this role, but as you point out, it's new and not much is known about long term use.  We know a little about effectiveness, and virtually nothing, on the basis of experience in lots of patients, about "long term" safety, e.g. more than 3 years.  

I took your letter as an opportunity to review what's been found so far on effectiveness; a comment on safety follows.  I only found one "randomized trial" on this subject, presented at a meeting last year; I emailed you the whole thing in case this link doesn't work.  Note that it's a study adding seroquel to Depakote, not Seroquel alone.    There are more trials underway, per this list from the manufacturer's website; note the latter two are "monotherapy" like your son is taking : 

Trial 99 & Trial 100 – combination therapy trials:

  • Trial 99 is examining Seroquel’s effectiveness as an adjunctive treatment to a mood stabilising agent.  It involves 32 centres and 178 patients with manic symptoms of acute bipolar disorder, from across the United States 
  • Trial 100 is Trial 99’s European sister trial, determining Seroquel’s effectiveness as an adjunctive treatment to a mood stabilising agent.  Trial 100 involves 220 patients in over 30 centres across Western and Southern Europe, North America and parts of Africa.

Trial 104 & 105 – monotherapy trials

  • Trial 104 is comparing the efficacy of Seroquel and haloperidol (a commonly prescribed antipsychotic agent) as monotherapy in acute mania in bipolar 1 disorder compared to placebo.  It will assess nearly 350 patients in 13 countries in Asia, Southern Europe and South America. 
  • Trial 105 is comparing Seroquel and lithium versus placebo, as monotherapy, in nearly 350 patients in the same countries as Trial 104.

This gives you an idea of the scope of the effort to understand the role of this medication in bipolar disorder.  In the process, there will be lots of opportunity to look for negative effects over time.  Sometimes it can take years before an adverse effect shows up, but Seroquel is looking pretty good in this respect so far (I don't agree with the data on their website about weight gain, as there is other research showing it's a problem for Seroquel too....)  Our understanding of long-term safety will be a while in coming.  But there are 850,000 people on it who started ahead of your son, some several years ahead.  Think of them as the pioneers, leading the way to the knowledge you want for your son.  

Dr. Phelps

Published October, 2002


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