From the WSJ....The Food and Drug Administration won't call for major changes to the safety labeling for the Sanofi-Aventis SA antibiotic Ketek, but a public meeting today is expected to highlight debate over the agency's handling of the drug.
The agency's newest views about Ketek became public in documents posted in advance of a gathering today and tomorrow of an advisory committee that is expected to weigh safety concerns tied to the drug, along with evidence for its efficacy.
From the WSJ
The Food and Drug Administration's plan to expand warnings about a link between antidepressants and suicidal thoughts and behavior to include young adults is sparking strong push-back from psychiatrists. That, in turn, raises questions about how wide an effect the change would have on prescribing patterns.
Yesterday, the agency proposed to add adults younger than 25 years old to the at-risk groups mentioned in the strong "black box" warning on the labels of antidepressant drugs. Currently, the warning says the medicines "increased the risk" of suicidal tendencies in children and adolescents in studies. But the FDA said its analysis shows the pattern reversed itself for people older than 30, and particularly for those over 65, for whom the drugs were associated with a protective effect against suicidal behavior, a point the agency also plans to add in the black box.
The FDA also reiterated the need for doctors to carefully monitor patients taking antidepressants for the emergence of, or increase in, any suicidal tendencies.
An FDA advisory committee, meeting yesterday, endorsed the agency's latest proposal by a 6-2 vote. But it also encouraged the FDA to add language to the black box about the importance of treating depression in hopes that the addition of new warnings won't cause doctors to limit the antidepressant prescriptions.
The FDA played it straight with the data and the advisory panel reflected clinical concerns as opposed to the shrieks of the crazies....
Shame on on the shameless Shankar Vedantam of the Washington Post who continues to continue space and legitimacy to the Sciento-illogical soundings of Alliance for Allen Life Form Protection....They still pump out the sewage that there is no biological basis for mental illness, the same crap Tom Cruise dumped on Matt Lauer. It reduced TomKat to a laughing stock. It gets the Alliance more coverage from Shankar...Is there any editorial oversight at the Washington Post?
The agency's newest views about Ketek became public in documents posted in advance of a gathering today and tomorrow of an advisory committee that is expected to weigh safety concerns tied to the drug, along with evidence for its efficacy.
From the WSJ
The Food and Drug Administration's plan to expand warnings about a link between antidepressants and suicidal thoughts and behavior to include young adults is sparking strong push-back from psychiatrists. That, in turn, raises questions about how wide an effect the change would have on prescribing patterns.
Yesterday, the agency proposed to add adults younger than 25 years old to the at-risk groups mentioned in the strong "black box" warning on the labels of antidepressant drugs. Currently, the warning says the medicines "increased the risk" of suicidal tendencies in children and adolescents in studies. But the FDA said its analysis shows the pattern reversed itself for people older than 30, and particularly for those over 65, for whom the drugs were associated with a protective effect against suicidal behavior, a point the agency also plans to add in the black box.
The FDA also reiterated the need for doctors to carefully monitor patients taking antidepressants for the emergence of, or increase in, any suicidal tendencies.
An FDA advisory committee, meeting yesterday, endorsed the agency's latest proposal by a 6-2 vote. But it also encouraged the FDA to add language to the black box about the importance of treating depression in hopes that the addition of new warnings won't cause doctors to limit the antidepressant prescriptions.
The FDA played it straight with the data and the advisory panel reflected clinical concerns as opposed to the shrieks of the crazies....
Shame on on the shameless Shankar Vedantam of the Washington Post who continues to continue space and legitimacy to the Sciento-illogical soundings of Alliance for Allen Life Form Protection....They still pump out the sewage that there is no biological basis for mental illness, the same crap Tom Cruise dumped on Matt Lauer. It reduced TomKat to a laughing stock. It gets the Alliance more coverage from Shankar...Is there any editorial oversight at the Washington Post?
