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FDA Warns Against Compounded Moxifloxacin Injections

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FDA received case reports of TASS (Toxic Anterior Segment Syndrome) following intraocular administration of compounded drugs using moxifloxacin as a bulk drug substance, as well as reports associated with the intraocular administration of repackaged and/or diluted FDA-approved moxifloxacin drugs.

Hello my name is kuzai and today we’re discussing a recent alert from the fda regarding compounded moxofloxacin if you’re watching us on youtube click the subscribe button and hit the bell icon so you can be notified when we post new updates you can also follow us on social media under eagle analytical the fda has issued an alert to health care professionals

Of the risks associated with intraocular use of compounded moxofloxacin we have dr david hussong here to give us more information so about two weeks ago the fda issued an alert for healthcare professionals and these are of course also for the public about some risks associated with intraocular use of the drug moxafloxacin the drug is often used after cataract

Surgery or other eye surgeries and the purpose is to prevent infections after a surgery so it’s a preventative step now the problem is there is no moxafloxacin approved by fda for intraocular use after surgery be prophylactic injections what has been reported is a number of cases of toxic anterior segment syndrome or tas tas happens when something irritates

The inside of the eye it’s often associated with an injection of something that irritates the surfaces of the eye the eye is kind of unique in the there’s very little blood flow associated with it there’s a closed uh chamber and there’s just a little bit of vascular surface around it so a toxic item in there would irritate that interior surface the solution

Inside the eye is very viscous so it doesn’t exchange easily as you might expect with a product injected into the bloodstream so fda had received 29 reports of people with tasks and these were associated with mostly cataract surgery and there is again no injection product for prevention of these infections in the eye moxafloxacin is often used as an eye

Drop that’s a topical drug the solution is applied to the surface of the eye it does not get in the eye but it prevents infections on those mucous surfaces around the eye so it’s a very effective treatment for people with certain eye infections not interior what has been happening is compounders will take the drug and use either an inappropriate drug raw

Material or they’ll use the eye drop and reformulate it and put it in syringes for injection now depending on how that reformulation works it’s very likely that they cannot bring it to the standard that is safe for an injection into the eye again the eye is very sensitive but there are many things that will irritate it including for example endotoxins which

Are common in topical drug products topical drug products are prepared using purified water purified water is not water for injection they differ primarily in this presence of endotoxins endotoxins in even fairly small amounts will create irritation in the eye further the dosing of moxafloxacin is very critical it can be found to irritate surfaces in the eye

At higher doses and the number of uh cases seem to be associated with increased dosing of the moxifloxacin so we have those issues to contend with you have to know what doses are being used what the source of the product is and the topical drugs are often formulated differently one formulation contains for example a thickening agent called xantham gum xanthan

Gum is known to cause irritation in the eye so if that were injected you have potential for task reactions now this is an old problem not so much just for moxoflexacin we’ve saw we saw this about 10 or 12 years ago with a drug called avastin avastin is an anti-cancer drug it’s also effective when used against age-related macular degeneration and avastin was

Then used off-label it’s not approved for this purpose used off-label reformulated and injected into the eye of patients with macular degeneration the result of this was also task related events some including blindness so it’s important for practitioners to know how the product was formulated where it was put together pharmacists should be aware when they

Compound this we’ve provided a link in the description section and on our website which leads to the fda alert to learn more about eagle and to stay connected with the latest science-based information visit our website at you

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FDA Warns Against Compounded Moxifloxacin Injections By Eagle Analytical