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Re: Topiramate users- black box warning » delna

Posted by Larry Hoover on April 9, 2005, at 22:38:25

In reply to Topiramate users- black box warning, posted by delna on April 9, 2005, at 18:56:10

> Hi all,
> I know that topirimate is sold in the USA with a black box warning regarding the potential danger of glaucoma.
> My question is this: Is there any warning anywhere on the BOX itself- or just on the insert.
> Just to let you know why I'm asking; It is sold in India without ANY warning whatsoever and I had a serious reaction to it. The drug company had not even informed the doctors about glaucoma as a side effect.
>
> Thanx
> Any info greatly appreciated

There is no black box warning for topiramate. There was a change in the insert in 2001 to reflect the discovery that rare cases of glaucoma had been reported. Here's the link to the FDA-approved warning letter: http://www.fda.gov/medwatch/SAFETY/2001/topamax_deardoc.PDF
Here's the link to the package insert section with the health warnings: http://www.rxlist.com/cgi/generic2/topiram_wcp.htm

Lar

 

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