Bipolar disorder

“This being the case,” she said, “I urge you to recommend that these drugs have an appropriate black box warning placed on the label starting immediately.”Sandra Lucas, appeared at the hearing to speak on behalf of the Citizens Commission on Human Rights, a psychiatric watchdog group, and told the panel, “we do know that the side effects of the stimulants are not only present, they are extremely serious and sometimes lethal.” “So,“ she asked the committee, “while the FDA ponders the problem of studying the issue and conducting the studies that may have inherent flaws, what real, immediate protections are to be put in place for parents and children?

”During the hearing, Drug Safety panel member, Dr Art Levin, told the committee, “I think we have to recognize that when a drug is approved and marketed the public assumes a level of comfort in the safety of that drug unless they are told otherwise.”“And, for us to sit around and talk about this,” he continued, “to have three advisory committee meetings discussing the signals and not to make, at the very least, a very strong warning to people that there is uncertainty here about the safety of these drugs and that they need to be aware of that pending clarification I just think is inappropriate, unethical behavior.”Committee member, Dr Steve Nissan advised, “we have to elevate the level of concern and if it slows the growth of this, that is probably appropriate because I think most observers would argue that ten per...

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