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Proper early response to hypomania caused by SSRI


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Hello,

I am planning to send a letter to Forest Laboratories, the makers of Lexapro. Please let me know if you have any criticisms or suggestions about my first draft. Thanks! Here is my draft:

To whom it may concern:

I am writing to give some thoughts about patient and doctor education regarding Lexapro, regarding hypomania and mania in particular, and perhaps also relevant to suicidality as hypomania and mania may be precursors to suicidality.

The Lexapro Prescribing Information states, "Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication."

This is useful information, which might have prevented my hospitalization due to mania if I had known about it, since if I had been better informed I might have contacted a doctor earlier about my hypomania symptoms. However, I wasn't given this information when I was prescribed Lexapro. I think it would be useful if you provided doctors with a handout for patients including all the information that your PI sheet says doctors should provide patients. The terms hypomania and mania, which are not widely understood outside the medical profession, could be accompanied by an explanation of the possible symptoms (such as irrationality and grandiosity, among others).

Your site lexapro.com also does not seem to give patients all of the information. In the information for patients at lexapro.com I found only this, under the heading IMPORTANT SAFETY INFORMATION on the lexapro.com start page: "Patients started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially at the beginning of therapy or at the time of dose changes.... Families and caregivers should be advised of the need for close observation and communication with the prescriber." This is much less comprehensive, and in my opinion much less useful, than the text which I quoted from the Lexapro Prescribing Information. If there is not room for the full text on the start page, or you wish to only provide summaries on the start page, then perhaps you could provide a web link there to another page with all the information.

I also have some thoughts regarding doctor education about the proper treatment of SSRI-induced hypomania. I am basing these thoughts on my own history. (In case you are wondering whether my history needs to be reported: when I called the Forest Professional Affairs Department to ask where to send this letter, the staff there took down my history for reporting to the FDA.) I was prescribed Lexapro for anxiety two years ago. I took half a tablet every morning for six days. In hindsight, by the third day I had become slightly hypomanic and on the fifth day I was quite hypomanic. The symptoms of my hypomania were sleeplessness (I had been sleeping less and less from one night to the next since I started the Lexapro) and irrational grandiose thoughts (which had started to appear in a mild form on the third day and which were strongly present by the fifth day). I did not know what hypomania was, nor did I realize the importance of contacting a doctor immediately. However, the accumulated lack of sleep made it difficult for me to function, so on the sixth day I contacted the doctor and complained about the sleeplessness. (I was embarrassed about the irrationality and did not mention it.) I was directed to stop taking the Lexapro and to get in touch again late the next afternoon. That night I could not sleep at all, and early the next afternoon I became psychotic and thus required hospitalization.

In hindsight, I believe that when I contacted the doctor on the sixth day I should have been given a prescription for a medication that would have acted as a mood stabilizer and sleep aid, since discontinuing the Lexapro was not sufficient to stop my sleeplessness and irrationality from worsening, and waiting a full day to check how my condition developed was too long. Since such medication is commonly prescribed for hypomania, perhaps the doctor simply did not suspect I was hypomanic since I did not report the irrationality. On the other hand, perhaps the doctor did not understand how rapidly deterioration can occur in such situations, and perhaps this is something that should be stressed more in your education of professionals. It is hard to know from my single case, but there are ways to find out more, such as asking a sample of doctors what they would do in various situations. Also, perhaps patients in general are more likely to volunteer reports of nonstigmatized symptoms such as sleeplessness, in which case perhaps doctors should be educated to ask questions about whether stigmatized symptoms such as irrationality are also present.

Yours truly,

...

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I wonder if the deterioration into hypo/mania is caused by the same mechanism as increased depression/suicidality.

Still though, I agree that the manufacturer should be including hypo/mania as a potential early side effect in the black box warning.

I know this right here sounds cynical -- but sometimes I get the feeling that physicians (most often GPs) will blindly prescribe the drug du jour presented to them the last time a drug company rep visited. If the doc is told that such and such SSRI/SSNRI is used to treat depression, they may well prescribe it to a bipolar suffering a depressive phase. When I first started Cymbalta in 2/2005, it was relatively near its introduction and my then GP's office (20 miles north of Indianapolis) was crawling with reps from a certain drug company based there. Fortunately for me, Cymbalta worked pretty well.

Some antidepressants list in their prescribing information a sort of "conversion from MDD to bipolar" side effect profile prominently, though most A/D manufacturers find in their trials that this conversion is similar to placebo and claim it's not a significant risk.

Of course, the drugmakers could just do controlled trials of their A/Ds on the treatment of BP2-induced depression, but that'd just be inviting it. I happen to be one BP2 individual who responds well to SSRIs/SSNRIs, but I know that serotonin meds can be hell for a lot of bipolars.

***sidebar/soapbox - is it just me, or does anybody else here feel that blindly flooding the brain with serotonin one of the stupidest things you can do to someone who's depressed, be they MDD or BP???*** [/sidebar]

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i'm sorry i can't be more helpful, but i have ADD (inattentive) as well as bipolar disorder, and long posts lose me. so i didn't read it.

however, i wanted to add my own fyi that hypomania caused by lex or other ssri drugs isn't THAT common. sure, it does happen, and can bring out the bipolar in people. that needs to be a listed side effect IMO.however, a black box? that, to me, is kind of drastic. it may disuade people who really need the drug from taking it for fear that they'll become bipolar. anyone with a history of bp in their family of course should be taken as a higher risk for bp and perhaps treated wtih a mood stabilizer, like lamictal, along with their lex to prevent any possible conversion to bp. the lamictal would also provide its own boost. (i love lamictal and could be a pharma rep for the stuff- pharma companies- get my number- i love lamictal!).

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Extremely well written letter, wish I could write as clearly.

It's unfortunate that you suffered a bad reaction and had to be hospitalized. Fortunately, such severe reactions are not the norm.

The patient education process is a shared responsibility between the physician, pharmacist and the patient himself. Given that you were being treated for anxiety I don't think it is reasonable for your doc to have even brought up the subjects of mania or psychosis and their symptoms. Likewise, you can't have been expected to put a name on your symptoms. Those of us who are bipolar can take a year or two learning to recognize the onset of mania/hypo states in ourselves.

The one error was in not being completely honest with your doctor about all your symptoms. A doctor cannot treat what he doesn't know exists. Supposing on what medication could have done what if it had been prescribed is getting quite hypothetical. I assure you that every doctor is familiar with how quickly psychosis can develop and could regail you with stories. I differ with you that this occured rapidly since it took 7 days to reach that point. However, the appearance of psychosis cannot be predicted, and docs are not going to throw meds at symptoms that don't exist. Telling you to call back the next day sounds emminently reasonable for your reported insomnia, and I have been told the same thing with hypomania and frank mania.

For the product manager of Lexapro, physician understanding of psychosis and the medical treatment of it is completely outside their responsibility.

I hope that you have gotten some relief from your anxiety in the intervening two years, and without any other such harrowing episodes.

Please do send your letter to the manufacturer! They need to hear from the users, and let us know if you get a response.

Best, a.m.

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Nice letter! Here are my suggestions:

I am writing to give some thoughts about patient and doctor education regarding Lexapro, regarding hypomania and mania in particular, and perhaps also relevant to suicidality as hypomania and mania may be precursors to suicidality.

State your purpose more clearly. "Give some thoughts" could mean anything: blabbing about nothing for a few paragraphs, a page from your journal, etc. Say something like: I am writing this letter to suggest placing a warning label on the antidepressant Lexapro regarding hypomania and mania.

The Lexapro Prescribing Information states, "Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication."

This is useful information, which might have prevented my hospitalization due to mania if I had known about it, since if I had been better informed I might have contacted a doctor earlier about my hypomania symptoms. However, I wasn't given this information when I was prescribed Lexapro. I think it would be useful if you provided doctors with a handout for patients including all the information that your PI sheet says doctors should provide patients. The terms hypomania and mania, which are not widely understood outside the medical profession, could be accompanied by an explanation of the possible symptoms (such as irrationality and grandiosity, among others).

I like this part. The only thing I might change is the order of thoughts in the second paragraph. First say what you want them to do, then tell them why.

Your site lexapro.com also does not seem to give patients all of the information. In the information for patients at lexapro.com I found only this, under the heading IMPORTANT SAFETY INFORMATION on the lexapro.com start page: "Patients started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially at the beginning of therapy or at the time of dose changes.... Families and caregivers should be advised of the need for close observation and communication with the prescriber." This is much less comprehensive, and in my opinion much less useful, than the text which I quoted from the Lexapro Prescribing Information. If there is not room for the full text on the start page, or you wish to only provide summaries on the start page, then perhaps you could provide a web link there to another page with all the information.

This is also good. Be more blunt with the first sentence. "Your site, www.lexapro.com, does not provide patients with this information either." Then clearly add your recommendation.

I also have some thoughts regarding doctor education about the proper treatment of SSRI-induced hypomania. I am basing these thoughts on my own history. (In case you are wondering whether my history needs to be reported: when I called the Forest Professional Affairs Department to ask where to send this letter, the staff there took down my history for reporting to the FDA.) I was prescribed Lexapro for anxiety two years ago. I took half a tablet every morning for six days. In hindsight, by the third day I had become slightly hypomanic and on the fifth day I was quite hypomanic. The symptoms of my hypomania were sleeplessness (I had been sleeping less and less from one night to the next since I started the Lexapro) and irrational grandiose thoughts (which had started to appear in a mild form on the third day and which were strongly present by the fifth day). I did not know what hypomania was, nor did I realize the importance of contacting a doctor immediately. However, the accumulated lack of sleep made it difficult for me to function, so on the sixth day I contacted the doctor and complained about the sleeplessness. (I was embarrassed about the irrationality and did not mention it.) I was directed to stop taking the Lexapro and to get in touch again late the next afternoon. That night I could not sleep at all, and early the next afternoon I became psychotic and thus required hospitalization.

In hindsight, I believe that when I contacted the doctor on the sixth day I should have been given a prescription for a medication that would have acted as a mood stabilizer and sleep aid, since discontinuing the Lexapro was not sufficient to stop my sleeplessness and irrationality from worsening, and waiting a full day to check how my condition developed was too long. Since such medication is commonly prescribed for hypomania, perhaps the doctor simply did not suspect I was hypomanic since I did not report the irrationality. On the other hand, perhaps the doctor did not understand how rapidly deterioration can occur in such situations, and perhaps this is something that should be stressed more in your education of professionals. It is hard to know from my single case, but there are ways to find out more, such as asking a sample of doctors what they would do in various situations. Also, perhaps patients in general are more likely to volunteer reports of nonstigmatized symptoms such as sleeplessness, in which case perhaps doctors should be educated to ask questions about whether stigmatized symptoms such as irrationality are also present.

Leave this part out of the letter completely. I think a.m. said it best. Doctors are educated in med school, not by pharmaceutical reps. Instead, write a short concluding paragraph. If you want to 'emotionalize' the letter instead, then say how adding this information will help people use the medication in a safe and effective way, while preventing hospitalization, in the future.

Feel free to post the final draft, and definitely do send it!

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Thanks for the replies! My main motivation for writing the letter was my recollection that the information sheet my doctor gave me did not warn me properly about mental side effects. I've decided that I misremembered that, because I have just checked several different resources about Lexapro online and they all warn that the user should report insomnia or hypomania/mania to their doctor. I'm sorry for the error. Given that, and the important points made by Loon and AirMarshall, I decided not to write to the manufacturer. Thanks again for your time. I feel a lot better now that I've learned from AirMarshall that my doctor handled things reasonably and from the Internet that the information out there for patients is better than I had thought.

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