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Old 11-19-2004, 05:20 AM   #1
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Question Serevent under investigation by FDA

I just got the tail end of a report on The Today Show this morning questioning the safety of several meds and one of them was serevent. Apparently the FDA is reviewing this drug. Has anyone heard the report and know why specifically they have serevent on this list?

 
Old 11-19-2004, 09:47 AM   #2
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Re: Serevent under investigation by FDA

Quote:
Originally Posted by ol'lady
I just got the tail end of a report on The Today Show this morning questioning the safety of several meds and one of them was serevent. Apparently the FDA is reviewing this drug. Has anyone heard the report and know why specifically they have serevent on this list?
Serevent is one of 5 listed drugs that also under investigation for dangerous side effects since the Vioxx scandal.

 
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Old 11-21-2004, 12:22 PM   #3
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Re: Serevent under investigation by FDA

My understanding is that use of serevent by itself has been linked to some problems in people already at risk for heart problems or other serious illnesses. Apparently use of it in combination with an inhaled corticosteroid (as in the RX drug Advair) is highly safe for the great majority of asthmatics.

I hope it won't be pulled, but that there will just be advisories put on it. As with any drug, anyone with one or more serious illnesses or risk factors needs to do a risk/benefit analysis of any drug they are taking on a regular basis.

 
Old 11-22-2004, 01:36 PM   #4
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Re: Serevent under investigation by FDA

One of the problems they've been having with Serevent is that it's been linked to premature asthmatic deaths. People will take it like Ventolin since it gives them relief just as fast, and it's happened several times that someone has been found dead of status asthmaticus with a Serevent puffer clutched in their fist. In all likelihood, it will not be pulled, since it's an extraordinarily effective drug when used appropriately. What they probably will do is make sure to mark more clearly that this drug is to be avoided in an emergency situation, that even though it may bring relief it is not to be taken as a rescue measure because of a risk of increased and possibly fatal side effects.

For them to pull it off the shelf they'd have to pull related drugs (foradil/oxeze) and drugs used in combination with it (advair) and their related drugs (symbicort). These are all drugs that have brought relief to millions, and that research shows are actually safer to take than corticosteroids alone since they result in a lower therapeutic dosage of corticosteroids and thereby fewer side effects.

And as an advisory, as much as your Ventolin or reliever of choice IS an emergency drug, if you find yourself having to take more than two puffs in a matter of four hours because the relief is not lasting as long as it should or you are not getting adequate relief, dispatch yourself to an emergency care center immediately, whether that be a walk-in clinic that treats emergent patients, your primary care physician, or the Emergency Department of your community hospital.

 
Old 11-24-2004, 07:11 PM   #5
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Re: Serevent under investigation by FDA

I heard that Serevent, as well as a few other drugs (Bextra, etc), were being questioned, but that it was dismissed and there will be no investigation.

Only what I heard though, I could be wrong.
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Old 11-24-2004, 09:52 PM   #6
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Re: Serevent under investigation by FDA

It was a reviewer who's critical of the FDA who said something, I believe, in Congress, about five drugs, and only that they should investigate them, not that they are being investigated. It was one of those things where the FDA later said "We stand behind our decisions" and it was not an opinion said directly by the FDA.

 
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