Bipolar Disorder

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Bipolar blogger Natasha Tracy offers exclusive insight into the world of bipolar disorder.

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Why Do Doctors Prescribe Medications Not Approved for Bipolar (Off Label)?

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a prescription bottleThe medication you’re taking right now might not have been approved for treating bipolar disorder. Really.

In fact, if I had to guess, I’d say that most people are on medications that have not been Food and Drug Administration (FDA)-approved for what they’re using it for. How can I say that? Well that’s easy. There aren’t that many drugs FDA-approved in bipolar disorder and those that are, are only approved during certain phases of the disorder.

What are the Drugs that are FDA-Approved for Bipolar Treatment?

There are 13 drugs that are approved for use in bipolar disorder but each drug is only approved for use during specific times.

Specifically:

Generic Name

Trade Name | 

Manic | 

Mixed | 

Maintenance | 

Depression

Valproate

Depakote

X

     

Carbamazepine ext. release

Equetro

X

X

   

Lamotrigine

Lamictal

   

X

 

Lithium

 

X

 

X

 

Aripiprazole

Abilify

X

X

X

 

Ziprasidone

Geodon

X

X

   

Risperidone

Risperdal

X

X

   

Asenapine

Saphris

X

X

   

Quetiapine

Seroquel

X

   

X

Chlorpromazine

Thorazine

X

     

Olanzapine

Zyprexa

X

X

X

 

Olanzapine/fluoxetine combo  

Symbyax

     

X

Lurasidone

Latuda

     

X

What’s Off Label Usage?

Off label usage then, is any use of any drug that is not in the above table used in the way indicated. So, if, for example, you’re taking valproate (Depakote) as a maintenance drug, that would be off label usage. You’ll note that there are no antidepressants on this list, so any antidepressant that you take is off label too.

You might be surprised at some of these approvals because, for example, one of the most common fighters of bipolar depression is actually lamotrigine (Lamictal) and quetiapine (Seroquel) is often used as a maintenance drug—neither of which are listed. Yeah, medications are like that.

All that labeled usage means is that the drug has been through the official drug trial process for that use and the FDA has accepted that it does, indeed, work for a reasonable number of people (above the placebo effect), for that use. (You might recall this has to do with the number needed to treat statistic I mentioned a few weeks ago.) The drug might be good at a lot of other things too, but if the correct studies haven’t been done, then they are not approved for those uses.

Why Go Off Label?

But the thing is, if we discover that a drug is good for something else—like we now know that lithium is good at reducing the risk of suicide—it still may never get approval for that use. And that’s because of money. It costs drug companies lots and lots of money to put a drug through a drug trial for approval, and if they don’t think they’ll get that money back (like, say, because the drug is out of patent, like lithium) then they certainly aren’t going to finance it.

Now, don’t get me wrong, it’s not that FDA-approval means nothing—it means a lot—it means that those are the drugs that should be frontline treatments for bipolar disorder. But many people need second and third line treatments and that’s where off label usage comes in.

What it comes down to is that any doctor can prescribe any medication for any reason—and really, it’s best that way. But what it also means is that the clinical judgement of your doctor is critical. There is no way to know what medication works for what part of bipolar disorder without extensive clinical knowledge and experience. This just underscores how important it is to see an experienced specialist that you trust.

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About the Author

Natasha Tracy is an award-winning writer who specializes in writing about bipolar disorder.

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