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Why venlafaxine discontinued in us a Venlafaxine's approval This is an interesting story. It began in 2002 when, Dr. David H. Freedman, professor of psychiatry at Harvard Medical School, was commissioned to cost of generic venlafaxine review the clinical and safety studies of venlafaxine in a major depression trial of 50,000 subjects. The results of his analysis were startling for antidepressants. There was, he said, insufficient evidence of efficacy, and the risks its side-effects outweighed benefits. "Although this review was undertaken before the first clinical study of venlafaxine in depression, the negative conclusions of Freedman's report are now widely acknowledged," states a 2006 report on the drug. Then-senior FDA official Arthur J. Zarin wrote a blistering letter to company executives citing the findings as justification for withdrawing the drug's market authorization as a category C drug. "The data presented by Dr. Freedman and his colleagues does not support approval," Zarin wrote. "There is no clinical indication for use of this drug the treatment major depressive disorder; substantial concerns about the safety of venlafaxine in depression do not constitute sufficient evidence to warrant drug approval." The issue was addressed in an amicus brief on behalf of the American Psychiatric Association in landmark 2007 Supreme Court case, Gilligan v. Breland. The court's majority opinion made clear that "the existence of some risk suicidal thinking or behavior" is not enough to prevent approval of a new drug, even if the risk is "relatively small." "What's the risk here?" I asked. "A psychiatric drug can't be safe if it doesn't work or causes suicidal thoughts." "No drug can be safe." "You are correct," he said. And then explained how the FDA evaluates risks and benefits of new drugs. "There is a risk of suicide," said Freedman. "I've seen them happen." Venlafaxine is given with psychotherapy. What does the FDA mean by an acceptable amount of suicidal Robaxin cost thoughts? A person could have suicidal thought for just about any reason except what they are told by a doctor: "Suicide is wrong, and suicidal thoughts are not correct; don't think about it." The FDA is supposed to assess risks and benefits individually, not just by considering whether one side effect outweighs another, as in the case of a heart attack, but that is the standard they have to apply. That is what Dr. venlafaxine buy online Freedman discovered. The court also pointed out that the FDA had rejected another antidepressant, sertraline, only to allow it be approved, with the additional caveat that FDA say its efficacy was limited. The FDA had rejected earlier, smaller study of venlafaxine's efficacy, but said at the time it would reconsider its decision after this one. No change came. "So here we are in 2008, six years later, and FDA is considering approval of this antidepressant, and it says, there's not enough data to give it approval," said Dr. Gary G. Greenspan of the New York State Psychiatric Institute and the New York State Psychiatric Nurses Association. He was speaking from an op-ed article in the Wall Street Journal, and he was referring to another drug approved at that time: Luvox. "If the data that is coming out of the FDA's own agency is that the data that's coming out of the major psychiatric research organizations is saying that you've got this really devastating effect on suicidal thinking, then you've got to get into these studies see if it's actually happening or not." The FDA is still on lookout for that kind of data, if only to make sure that antidepressants are not contributing to a significant number of suicides.
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