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Bipolar Disorder Blog

By Kimberly Read & Marcia Purse, About.com Guides to Bipolar Disorder since 1998

FDA Approved Medications for Treating Bipolar Disorder

Wednesday August 29, 2007
I was reading an article regarding the STEP-BD program’s research with bipolar depression. An interesting fact shared is the limited number of Food and Drug Administration approvals for medications to treat bipolar disorder.

FDA Approved Drugs for Mania
  • Aripiprazole
  • Carbamazepine
  • Chlorpromazine
  • Divalproex
  • Lithium
  • Olanzapine
  • Quetiapine
  • Risperidone
  • Ziprasidone
FDA Approved Drugs for Bipolar Depression
  • Olanzapine-Fluoxetine Combination
  • Quetiapine
This means that the majority of medications prescribed for bipolar disorder are done so off-label. Off-label is defined as “a drug prescribed for a particular indication even though the drug has not yet received approval from the Food and Drug Administration for that disease, condition, or symptom” (definition from Dictionary.com). And this brings us to the thrust of this research article – a great deal more research is needed.

However, this is changing. “After decades of languishing with minimal research and few treatment options, the investment of the federal government in projects like STEP-BD and large psychopharmacology companies’ interest in developing new treatments for bipolar disorder that has occurred in the last decade suggest that the future for the treatment of bipolar disorder will be steadily becoming brighter.” Approaching the Challenge of Bipolar Depression: Results from STEP-BD by Dr. Stephen M. Strakowski.

Comments

August 30, 2007 at 9:37 am
(1) Charlie says:

I thought that Lamotrigine (Lamictal) was approved by the FDA for Bipolar Depression in 2003.

August 30, 2007 at 11:36 am
(2) Kimberly Read says:

Hi Charlie,

In 2003, Lamotrigine (Lamictal) received FDA approval as a maintenance therapy to delay the recurrance of episodes. It has not been approved to treat episodes of either mania or depression. I’ve appended an excerpt from the label:

Bipolar Disorder: LAMICTAL is indicated for the maintenance treatment of Bipolar I Disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. The effectiveness of LAMICTAL in the acute treatment of mood episodes has not been established.

See Lamictal Label Approval History

August 30, 2007 at 1:33 pm
(3) Charlie says:

Thanks for clearing that up.

August 30, 2007 at 4:32 pm
(4) James E Jones says:

I think “About” has been taken over by “large psychopharmacology companies”.
I came to this page from another page. I would never read anything on “About” since I saw a 100% lie on another “About” story. I am sure was written by a drug company. I didn’t read this story because I expected it to be full of BS.

April 14, 2009 at 11:55 am
(5) Stephen T Dowden says:

Using my personal anecdotal data I feel that Lithium is also effective against depression.

You can not always go by the labels. The literature for Zoloft states that the maximum range to be 200 mg per day. I currently take 300 mg per day. My Psychiatris says that he has patients taking 400 mg per day.

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