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Old 06-09-2005, 01:05 PM   #1
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Black box warning.

Can someone explain what one is? I know it has something to do with the F.D.A But for example,The F.D.A wasn't happy with all the research done on a drug. I thought the F.D.A wouldn't approve of a drug that they weren't sure of.

 
Old 06-09-2005, 01:19 PM   #2
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Re: Black box warning.

A block box warning is the hghest level warning they gve on a med before yanking it from the shelves. BB warnings usually cme out after a drug has been on the market. When toraol first came out it was the wonder drug and answer for patients requesting opiates as fa as docs were concewrned, after a few years and some substantial data on kidney damge, it now has a black box warning that it shouldn't be used longer than 10 days straight. Before Viox was yanked from the shelf, a black box warning came first, not to prescrbe to patents with cardio and BP histories.

There is a black box warning on most of the highest strength opiates, The 100ugh patch should only be used for opiate tolerant patients, OxyC 80 mgs, should only be used on opiate tolerant patients. MSC 200 should only be used on opiate tolerant patients. These are all black box warning that are in effect, but I don't see the stronger opiates with a BB warning being pulled any time soon. It's simply a strong warning at the top of the full prescribing info on specific drugs that have specific risks. The warnng in the black box makes it hard to miss.

Take care, Dave

If you go here, the full prescribing info on OxyContin, the information in the black box is the actual black box warning, One for opiate tolerant patients for the 80mg and 160mg strength and another about potential for abuse and overdose if missused.
http://www.pharma.com/PI/Prescription/Oxycontin.pdf

Last edited by Shoreline; 06-09-2005 at 01:26 PM.

 
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Old 06-09-2005, 01:30 PM   #3
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Re: Black box warning.

Thanks dave! I know we talked about this some time ago,thanks again

 
Old 06-10-2005, 01:52 PM   #4
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Re: Black box warning.

Speaking of toradol, the risk of bleed out from GI complications is extremely high on it as well.

It may have a black box for that as well.

 
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