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 Marcia Purse

Abilify Study Flawed, Say Researchers - Is Long-Term Use Appropriate?

By May 9, 2011

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Abilify study flawed, say researchersAbilify is an atypical antipsychotic that was originally approved (in 2002) to treat schizophrenia. In 2004 the drug was approved to treat acute manic and mixed episodes of bipolar disorder, and in 2005 the FDA approved Abilify for long-term maintenance therapy in bipolar disorder.

Now Harvard University researchers say that the 2005 approval was based on a single clinical study that had serious flaws. Psychiatrist Alexander C. Tsai, M.D., one of the lead authors of the current review, said the methodology was biased in favor of Abilify and the study was too short to give credible information about long-term use. In addition, that single study was funded by the companies that developed and market Abilify.

This does not mean you should stop taking Abilify immediately. Rapid withdrawal can cause serious side effects, for one thing. For another, says Dr. Tsai, "It may actually be working for some people. But it's certainly worth talking to your doctor about how it's working for you."

Dr. Tsai said his main concern "is that patients are getting diverted from more effective treatments." He also commented on the high cost of Abilify and said, "Frankly, I think it's an embarrassment to the profession that [Abilify] has been accepted so uncritically for this indication."

In their discussion of the study, the researchers wrote, "This lack of robust evidence of [Abilify's] benefit should be weighed against the potential for long-term harms that have been described with other antipsychotic medications and adverse events related to aripiprazole use, including tremor, akathisia, and significant weight gain." A spokesman for Bristol-Meyers Squibb said that there are other unpublished studies demonstrating the long-term benefits of Abilify that they will now make available. And a spokesman for the FDA said the agency will review the Harvard study.

Tsai AC, Rosenlicht NZ, Jureidini JN, Parry PI, Spielmans GI, et al. 2011 Aripiprazole in the Maintenance Treatment of Bipolar Disorder: A Critical Review of the Evidence and Its Dissemination into the Scientific Literature. PLoS Med 8(5): e1000434. doi:10.1371/journal.pmed.1000434

Peeples, Lynn. Long-Term Use of Bipolar Drug Questioned. Health.com. May 3, 2011.

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May 10, 2011 at 9:47 am
(1) Vito desimini says:

I was taking abilify and stopped .
I wasn’t feeling the medicine was helping .
The side effects & withdrawal symptoms were
terrible .
I can’t believe I was given abilify that was
first approved for sczophrenia .
I was depresssed not sczo
I’m so glad I discontinued using abilify
This article is very upsetting !
But I’m glad I read it .
Thanks for the info .

May 10, 2011 at 12:11 pm
(2) jane says:

My son takes abilify and it seems to be the only thing that helps him cope. However, he does have the tremors and weight gain. If there is something else that would work as well and NOT have the side effects, I would love to know what it is. Everytime we try to take him off the abilify, he gets unbearable.

May 10, 2011 at 1:59 pm
(3) Laura says:

My son also takes Abilify. He was put on it 3 years ago and it was LIFE CHANGING!! If he does not take it, he is also unbearable. He takes a med to control the tremors. He has also gained some weight, but not near as much as with risperdal. Abilify is the ONLY thing that has truly worked for any length of time. What other real options are there?

May 11, 2011 at 9:26 pm
(4) cheryetc says:

I’ve been on Abilify for about 5 yrs. Prior to taking it I was often delusional, had bad mixed episodes and was off the hook most of the time. I have been on MANY different meds over the years and none of them did much. I’m still not completely stabalized but, taking Abilify has had a profound affect on my life. I actually started seeing signs of the person I used to be and had thought was dead and gone forever and ultimately found her again. Recently, my insurance company wanted me to try something else that was “cheaper” for them. It felt like they were trying to take away my OXYGEN!! I guess I’m fortunate in that I’ve never gained a pound from it (like I did from virtually everything else I’ve ever taken) nor do I have tremors. I’m very aware of the possible long term effects which kept me from taking any antipychotic for years. But it was either try this or ECTs so I finally agreed. It still scares me to take it, but it scares a whole lot more to think of what my life would be again to not. So if it does help you, just think of the alternative first.

February 3, 2012 at 11:21 am
(5) John Lacy says:

My adult son took Abilify, I think for two years, but experienced huge weight gain and other side effects, including a severe thought disturbance that gave him unnatural thoughts about children that he had never experienced before. He repeatedly protested to his doctors that Abilify did not suit him because of the range of side effects but the medical response was that he needed a higher dose – and the side effects worsened. Eventually, after a serious lapse into severe depression, he persuaded his medical practitioners to take him off Abilify. He has now been off Abilify for over a year but the unnatural thoughts have persisted, albeit slightly diminished. He has worked hard to try to pull himself together and has lost about 25 kilos. However, he feels unable to leave the house most of the time because he fears seeing children and confines his shopping to late at night when there are only a few adults in the supermarkets. He believes the mental effects of the Abilify still linger, but the main effect of having unnatural thoughts disturbs him so much that he has developed a deep sense of shame and has become what I can see is ‘terminally suicidal’ and extremely depressed. His face shows me a mask, behind which I know his pain is insufferable. He was not like this on earlier medications. He is presently in a locked psychiatric ward where he is under constant surveillance to minimise the possibility of suicide. I post this wondering whether other males taking Abilify have suffered this awful distortion of their normal personality? I also question the science behind the introduction of Abilify and would like to see a close investigation of the unseemly haste with which this apparently flawed and dreadful treatment was shoved onto the market and somehow approved when so little was really known about it. ‘Money uber alles!’

February 4, 2012 at 7:59 pm
(6) Andy Behrman says:

I was the former spokesman for Abilify and Bristol Myers Squibb when it was first introduced and it was prescribed for me for my bipolar disorder before it was even approved by the FDA for use for bipolar disorder. I’ve been on more than 35 medications in my battle with bipolar, but no drug has ever had an effect on my like Abilify (i.e. cognitive impairment, akathisia). Of course, some drugs work for some patients and others do not, but in collecting information about Abilify for more than five years, I’ve heard more serious complaints about this drug than any other drug. So reading the story above about a man whose life has been permanently altered is not an uncommon story. In fact, I’ve heard much worse. Bristol Myers Squibb knows that Abilify is not a “wonder drug,” but is is quickly becoming of the most popular drugs (and lucrative for BMS). I believe, in time, we’ll learn how dangerous this drug really is and that it was brought to market too quickly. Fortunately, I’m not one of the patients who experienced suicidal ideation on Abilify, but this is extremely common. You may want to watch this video which may give you some more information:

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