March 23, 2009FDA Approves Prozac/Zyprexa Combo Drug For DepressionIn a sign of just how bizarre things have gotten in DC, the FDA today approved Symbyax for treatment resistant depression, meaning depression that hasn't responded to two anti-depressants. Since anti-depressants don't work too well, that ought to be an easy market for Eli Lilly to market to. Symbyax is Lilly's longstanding Zyprexa/Prozac combo drug. So the FDA just approved a drug that's known to cause diabetes, epic weight gain and suicidality to treat depression. This makes so much sense! Symbyax has never sold well, so it'll be interesting to see how this plays out. Separately, the agency also approved Lilly's request to approve Zyprexa and Prozac in separate pills to treat bipolar depression and treatment resistant depression. Seriously. At this point, I'm certain that you could get literally anything approved for depression. Let the TV ads begin. Posted by Philip Dawdy at March 23, 2009 01:43 PM
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Unbelievable. Glad I absconded when I did. Posted by: Lisa at March 23, 2009 04:56 PMWasn't the FDA going to have this huge change under the new progressive administration? Amazing that it still appears as if the FDA is completely on the take, bought, and paid for by the huge pharmaceutical conglomerates’ So much for government looking out for the people they represent. It's also too bad for all those that wasted their time sending in those letters and testimony into the FDA sub-committee on Seroquel XR getting a free ticket to treat just about anything including stubbed toes and tooth aches; since the public hearing is nothing but a check off box in the rubber stamp process. What wonderful times we live in for all humanity. Obama, is it true pay back is a ______? This is a case study in how marketing prevails over best medical practice. This approval of the combination antidepressant-antipsychotic product Symbyax is bad for patients and may well be bad for Lilly. I told Lilly several years ago that I thought they were foolish and reckless to pursue approval of Symbyax for depression. Symbyax is Zyprexa plus Prozac. For patients, taking the combination locks them in to a fixed ratio of the two medications, thus removing therapeutic flexibility. The side effect profile of the “atypical antipsychotic” drug Zyprexa is disturbing, and exposes patients to unnecessary risk. The worst side effect, besides the metabolic problems and diabetes, is tardive dyskinesia (TD) with long term use. Depressed patients seem to be especially susceptible to this syndrome of involuntary muscle movements in the mouth, tongue, face, and elsewhere. It can be very disfiguring. And permanent. We can put numbers on this risk of TD. In adult patients with schizophrenia the risk of TD with Zyprexa treatment is about 2.5% at 1 year. In children and adolescents treated with Zyprexa or similar “atypical antipsychotic” drugs for 6 months the risk is an alarming 6%. So, when Symbyax is promoted early and often for depression in primary care, look for a new cohort of patients with TD and a fresh round of lawsuits against Lilly. This is a case where psychiatrist key opinion leaders have been found wanting and where patients will be damaged unnecessarily. Here are some links. http://hcrenewal.blogspot.com/2008/01/antipsychotic-drugs-for-depression.html#links http://hcrenewal.blogspot.com/2008/01/variations-on-theme-of-sleaze.html#links Lisa, Thanks for the information and the links, Bernard Carroll. I just wanted to point out that the worst side effect of Zyprexa is death. Posted by: anonymous at March 24, 2009 06:18 AMLilly has balls to re-market Zyprexa and Prozac again, and drag out this old pill too. Will this ever stop?! What the hell is the FDA? a worthless entity that pumps out drug approvals with reckless abandon! I can't wait to hear Seroquel XR gets approved despite public testimony. Posted by: Stephany at March 25, 2009 03:51 AMA number of us emailed in before the deadline to testify at the Seroquel XR FDA Hearing April 8. Guess how many of us have been notified of our "moments to speak"? Smbyaxx.....2 x 2 = DEATH Posted by: anonymous at March 26, 2009 11:11 AMSigh. Looks as if there is no chance for getting lithobid/Eskalith/lithium off the market even under a supposedly new FDA. I am being contacted by more and more folks with chronic kidney disease from lithium. Please folks, if you ever took it for any amount of time, like a year or more, get your kidney function checked by a blood test now. Some of these folks have been off of it for many years as I was... Posted by: Alison Hymes at March 26, 2009 03:10 PMPost a comment
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