The other day, I had a nosebleed that wouldn't stop. The PI sheet says my new med can interfere with platelets, admittedly not very high on the list of side effects. But I contacted the doc. "Really?" she said, "Where did you hear that was a side effect?" My answer, "On the PI sheet you gave me." It turned out, my blood work was fine, and the humidifier took care of the nosebleeds.
No harm done. Right?
On the other hand, five years ago my GP had me on Prozac. After a couple months, I couldn't sleep, was irritated, agitated, couldn't concentrate, had thoughts of harming myself and others. The PI sheet said I should tell my doctor. My doctor increased the dose.
Thus began a series of antidepressants, and a downward spiral that has ended with disability.
Actually, my GP was operating by the book. Eli Lilly wrote the book. They convinced family practitioners around the world that SSRIs were safe, effective, and an easy solution to an easily diagnosed condition. After I quit Prozac for a different side effect, and after the second SSRI also made me worse, she followed standard procedure, and sent me to a psychiatrist.
Eventually out of self defense, I started reading more than the PI sheets. I read the research.
Does anybody out there have a doc who reads the PI sheets?
This is what I read in the doctor's information about Cymbalta (an SNRI), the December 2005 version:
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms.
These paragraphs were found on pages 7-8 of the 27 page document, appearing after the black box warning about children, the drawing of the molecule, the pharmocodynamics, the pharmocokinetics and the clinical studies. It didn't just jump out at you. This version for doctors was published right after the drug companies lost the battle they fought tooth and nail against those black box warnings.
December, 2005 was exactly the month when my second psychiatrist prescribed Cymbalta for me, (relapsed after a period of remission,) some time after the widely reported controversies and clinical studies that led the FDA to require the warning. She pulled the samples out of her sample cupboard. Didn't the sales rep give her the doctor's prescribing information? Didn't she read it?
That psychiatrist didn't answer phone calls about side effects.
Do Antidepressants T(h)reat(en) Depressives? is a review of literature (published in 2006) that exonerates antidepressants from the charge of causing suicidal ideation and behavior. However, its authors, Z. Rihmer and H. Akiskal do cite several clinical studies from 1999-2005 that identify a particular population besides children at risk: those with bipolar, Bipolar II, anxious depression and mixed state depression. All these are on a continuum of cycling depressions, with bipolar at one end and recurrent depression at the other.
The continuum's middle, especially Bipolar II is the most treacherous ground. People with this type of mood disorder are already at an elevated risk for suicide. Each hypomanic symptom increases the risk of suicidal ideation by 4.2%. Rihmer and Akiskal report that those who take antidepressants double their risk of suicidal ideation, self-harm and completed suicides over the risk to those with bipolar and triple the risk to those with simple major depressive disorder.
And how was this population and this elevated risk identified? Largely, by the list of side effects themselves that they experienced, Cymbalta's list above. Bipolar II is diagnosed after treatments for other diagnoses fail. A friend discovered that her psychiatrist had added Bipolar II to her diagnosis. When questioned, the psychiatrist said, "Oh, that simply identifies how you respond to antidepressants."
In fact, Baldessarini, Tondo and Hennen found in 1999 that women with Bipolar II were not correctly diagnosed for an average of eleven years. (Half of all suicidal acts occurred in the first 7.5 years of 19 years that were included in the study.)
Let's put all this together. Well, first -- let us recognize that most people with Bipolar II do survive the disease without self harm or suicide. And with proper treatment, including the correct meds, they can thrive.
That said, Bipolar II is a particularly dangerous form of mood disorder. People with Bipolar II, already at a higher risk of suicide, increase their risk when they take antidepressants. Nevertheless, they often do take antidepressants, because Bipolar II is notoriously difficult to diagnosis. But a major clue to diagnosis is the side effects experienced when taking antidepressants.
- Take an online screening for Bipolar II, a Mood Disorder Questionnaire (MDQ). Get the people who live with you and/or are closest to you to answer it with you. You won't recognize symptoms of hypomania. They will.
- Then get a psychiatrist to give you a thorough and careful screening for Bipolar II. This will take time. If you have to go out of network to find a psychiatrist who does more than the fifteen minute intake, pay the extra.
- Ask whether you should quit your antidepressant. Ask for a mood stabilizer.
- Check out McMan's Depression and Bipolar Web and its various pages for more information. This site has more information than Depression and Bipolar Support Alliance (DBSA). Oddly, National Alliance on Mental Illness (NAMI) has no information on Bipolar II at all.
The Scream by Edvard Munch