Re: Is it safer to just have the flu?bigvince wrote:
> On Nov 24, 9:15 am, Jeff <kidsdoc2...@hotmail . com > wrote:
>> bigvince wrote:
>>> "FDA staff urges warning for flu drug Reuters labels
>>> " * news.yahoo . com /s/nm/20071123/us nm/fda fludrugs dc 2
>>> Fri Nov 23, 10:59 AM ET
>>> WASHINGTON (Reuters) - Food and Drug Administration staff are
>>> recommending new warnings about psychiatric events observed in
>>> patients on Roche Holding AG's Tamiflu and GlaxoSmithKline Plc's
>>> Relenza, according to documents posted on Friday.
>>> An FDA advisory panel will discuss the recommendations for these
>>> influenza drugs at a meeting on the drugs' safety next week. The FDA
>>> held a similar meeting two years ago on Tamiflu, after reports of
>>> deaths of children in Japan linked to abnormal psychiatric
>>> behavior......
>>> .........In documents prepared for the meeting next week and posted on
>>> the FDA Web site, FDA staff recommend that Tamiflu's label be changed
>>> to note "some cases in Japanese adult and pediatric patients resulted
>>> in a fatal outcome."
>>> The FDA staff also reviewed Relenza, a drug in the same class as
>>> Tamiflu, recommending its label be changed to note "reports of
>>> hallucinations, delirium and abnormal behavior" observed in some
>>> patients taking the drug'
>>> Thanks Vince
>> Have any of these abnormal behaviors resulted in deaths? We already know
>> that the flu results in deaths every year.
>>
>
>
> Sure Jeff let me eliminate some of the words that apparently confused
> you from the original story.
>
> " FDA staff recommend that Tamiflu's label be changed
> to note "some cases in Japanese adult and pediatric patients resulted
> in a fatal outcome.""
sorry, I missed that. however, with proper monitoring of patients on the
drug, these types deaths will be rare, at most. In addition, the death
rates of people with influenza who are on the drug are significantly
lower than the death rates of people who have the flu and don't take the
drug. So the drugs save lives.
The warning on the package clearly says that the contribution of the
drug to the deaths is uncertain: "Neuropsychiatric Events. There have
been postmarketing reports (mostly from Japan) of self-injury and
delirium with the use of TAMIFLU in patients with influenza. The reports
were primarily among pediatric patients. The relative contribution of
the drug to these events is not known. Patients with influenza should be
closely monitored for signs of abnormal behavior throughout the
treatment period."
> Jeff do you see that fatal outcome = death. I know in the sales
> department these unpleasant facts must be ignorned.
I have never been in the sales department.
> The answer is yes.
And the answer is that the drug still saves lives, and the deaths
reported may or may not be related to the drug.
Jeff