FDA approval of 25% fluorescein sodium https://www.opsweb.org/forums/posts.aspx?topic=519097 Mon, 15 Jun 2026 10:05:25 GMT Thu, 10 Jan 2013 17:42:56 GMT Copyright © 2013 Ophthalmic Photographers' Society FDA approval of 25% fluorescein sodium https://www.opsweb.org/forums/posts.aspx?topic=519097 https://www.opsweb.org/forums/posts.aspx?topic=519097 HI  OPS,

A colleague has asked about the FDA approval status on 25% fluorescein sodium... this imager had heard that not all 25% fluorescein has that approval, and her group will not purchase 25% until it has been attained.

This is an issue I am not aware of, and I am wondering if someone can enlighten me / us?  We do not use 25% at our institution, so I admit I am completely in the dark and can't help my colleague with a useful answer.  Any information will be greatly appreciated!

Thanks and looking forward to learning more,

Paula

]]> Wed, 9 Jan 2013 19:41:23 GMT https://www.opsweb.org/forums/posts.aspx?topic=519104 https://www.opsweb.org/forums/posts.aspx?topic=519104 Hi

It seems to be listed on the FDA website of Approved Drug Products.

Says that AK-FLUOR 25% was approved in 2008.

If you go to the link below and type "Sodium Fluorescein" in the search field you can explore the results.

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

Leslie

]]> Wed, 9 Jan 2013 19:53:56 GMT https://www.opsweb.org/forums/posts.aspx?topic=519228 https://www.opsweb.org/forums/posts.aspx?topic=519228 Wed, 9 Jan 2013 23:48:27 GMT https://www.opsweb.org/forums/posts.aspx?topic=519474 https://www.opsweb.org/forums/posts.aspx?topic=519474 This was the first hit on Google search for "FDA approval of sodium fluorescein". 

http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm280534.htm

]]> Thu, 10 Jan 2013 14:37:26 GMT https://www.opsweb.org/forums/posts.aspx?topic=519566 https://www.opsweb.org/forums/posts.aspx?topic=519566 We use 10% but about 5 years ago we had two of dye lots  that seemed to trigger a higher incidence of nausea.  Our institution has a pharmacy co-op which dictates our supplies so we were compelled to stay with the same vendor .  They replaced the boxewe returned to them and we had no more trouble.

Years ago, (and I mean back in the 70s and 80s), there was speculation that dye impurities were the culprit in nausea, but with all the care that is used now, that doesn't seem a reasonable explanation.

Is there a chemist or physiologist out there that can discuss if there are true differences in dye lots that trigger nausea, or is it just coincidental?

Just wonderin'.  Thanks for the feedback,

Paula

]]> Thu, 10 Jan 2013 17:32:53 GMT https://www.opsweb.org/forums/posts.aspx?topic=519577 https://www.opsweb.org/forums/posts.aspx?topic=519577 Paula,

Check out: Eutick M. Sodium fluorescein – colourful past, bright future. J Ophthalmic Photography 28:66-70, 2006

If I get a chance later today, I'll dig up the PDF and post a link for those that don't have a hard copy of the JOP handy.

]]> Thu, 10 Jan 2013 17:45:12 GMT https://www.opsweb.org/forums/posts.aspx?topic=519607 https://www.opsweb.org/forums/posts.aspx?topic=519607 Here's the link.

You can also find it in the reference list of Fluorescein Fundamentals here on the site.

]]> Thu, 10 Jan 2013 18:02:48 GMT https://www.opsweb.org/forums/posts.aspx?topic=519618 https://www.opsweb.org/forums/posts.aspx?topic=519618 Thu, 10 Jan 2013 18:22:37 GMT https://www.opsweb.org/forums/posts.aspx?topic=519634 https://www.opsweb.org/forums/posts.aspx?topic=519634 Yep  - Mal Eutick's paper explains it all... not as many purification processes as I would have thought.  Fluorescein sodium is still a good tool.

Mal presented a paper on this topic at the 2002 ICOP in Adelaide after colleagues in OZ experienced a significant incidence of adverse effects.  Angela Chappell and Anton Drew were key in recruiting him to talk at the ICOP conference.  He and his company really took ownershp of the problem and worked to find the answer.

What an interesting, engaging guy he is!

]]> Thu, 10 Jan 2013 18:42:56 GMT