This is not to say that Trileptal doesn't work at all as a treatment for bipolar disorder. Your doctor may still prescribe it to you off-label as a mood stabilizer, and you may find it effective. Trileptal is one of a number of drugs used in treating bipolar disorder that haven't been specifically approved by the Food and Drug Administration for that particular use - and such drugs do help many people.
The issue here is that because Trileptal is only approved for treating epilepsy, it can only be marketed for treating epilepsy. However, Novartis trained its sales representatives to promote the drug for both bipolar disorder and nerve pain, sending them to the offices of psychiatrists and doctors who work in pain management. The company also paid kickbacks to doctors to get them to prescribe the drug off-label.
Novartis is paying $422.5 million in penalties, according to the Associated Press, and another $237.5 million to settle civil lawsuits arising from the issues.
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This is silly. Novartis is going to recover these costs by jacking up prices of its drugs and the tax payer will be the loser. The fine should be kept as a refundable deposit. If oxcarbazepine is proved to be effective for Bipolar Disorder then the fine should be refunded, less expenses or 10%.
Oxcarbazepine has done wonders in stabilising my moods. Not only that – it actually gets me going. It has pushed up my motivation level. I am doing things which I was procrastinating on. And my impulsivity and anger tantrums are practically gone.
Why does the FDA think that it is not suitable for Bipolar Disorder? Same with topiramate. This miracle drug has taken care of my co-morbid alcohol abuse (at just 25 mg once a day) to such an extent that I do not even so much as notice wine shops which I have frequented for years.
I think the guys at the FDA strongly need psychiatric treatment with oxcarbazepine to cool down their silly impulsive decisions.
rgds
Hello Devesh Desai … I’m pleased to hear about your medication success … one needs to know alittle how the FDA world works … drugs are approved after studies … long studies … each study is for each intended use of a drug … why … safety … one drug might be safe for one use … not for another … I take a cocktail of medications … LITHIUM approved for depression – bipolar … CYMBALTA approved depression – anxiety disorder – nerve pain … LAMITAL approved for bipolar … SEROQUIL APPROVED for bipolar … SEROQUEL NOT APPROVED SLEEP AID … TOPAMAX NOT APPROVED FOR BIPOLAR OR WEIGHT LOSS … these medication choices where discussed between my doctor and myself … making sure the combination is safe … I don’t burdened myself with corporate money issues … if a company wants to invest many years into research … I’m very greatful … the past years there are more medications for people like us … actually giving us choices … giving us a life and a future!
stable at last … Wild Cat Wife
The side effects of Trileptal almost killed me. No exaggeration. I was prescribed it for my bipolar disorder. What no one thought to tell me, was that it can severely lower your sodium levels. Mine went down to 115. The norm is 138.
I was in intensive care for 9 days, and spent a total of 12 days in the hospital.
Had I known that it was not FDA approved for the treatment of bipolar disorder, would I still have taken it? I honestly don’t know.
This occurred in 2003, when there were so many different medications being trumpeted for bipolar disorder 1, and many many of them were “thrown” at me, by PDOCs who had no idea how to treat me.