The Food and Drug Administration (FDA) alerts health care professionals of risks associated with intraocular use of compounded moxifloxacin.
“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 withthe intraocular administration of repackaged and/or diluted
FDA-approved Moxifloxacin drugs. FDA searched the Adverse Event Reporting System (FAERS) database for all reports through December 19,2019 and identified 29 cases that described TASS associated with intraocular administration of drugs containing Moxifloxacin.” - Full Press Release
As a responsible provider of trusted 503B outsourcing, Fagron SterileServices US (FSS) is committed to providing a reliable supply of high-quality medications, to our customers and the patients they serve. Recently, the FDA publish a warning regarding adverse events associated with certain types of compounded Moxifloxacin injectables.
FSS' Moxifloxacin Products
There appear to be outsourcing facilities using Vigamox or Moxeza as a basis for a repackaged injectable Moxifloxacin. FSS has never repackaged Vigamox to be used for an injectable.
• FSS has always labeled its Vigamox repack as topical only, not for injection.
• Vigamox is contraindicated for injection and its package insert expressly states: 4.4 - Special warnings and precautions for use
• Vigamox solution should not be injected subconjunctivally or introduced directly into the anterior chamber of the eye.
• Moxeza has a preservative and should never be used as a basis for an intraocular injection.
From the FDA warning: “ophthalmologists have used Moxifloxacin ophthalmic solutions, approved for topical administration, as the starting material to prepare Moxifloxacin drugs for use during intraocular procedures.” – This is a practice FSS have never engaged in.
• All FSS Moxifloxacin products are manufactured from commercial products listed in the FDA registry of approved drugs. They are not manufactured from bulk powders.
• It appears some outsourcing facilities are using bulk API (active pharmaceutical ingredient) Moxifloxacin to prepare an injectable at a concentration equal to Vigamox.
• FSS’ Moxifloxacin injectables do not contain potentially harmful inactive ingredients, such as xanthan gum 8,9. There are only two inactive ingredients in FSS’ generic for Avelox injectables:
- sodium
- chloride water
Additionally, the FDA cautions health care profession to carefully consider the concentration and inactive ingredients of any Moxifloxacin drug before intraocular administration.
Questions?
FSS is your ally when it comes to sterile 503B outsourcing. If you have questions or need additional clarification surrounding this ophthalmic FDA alert for Moxifloxacin, please do not hesitate to contact us today.
For your convenience, contact Glen Olsheim, VP of New Product & Business Development, directly at glen.olsheim@fagronsterile.com.
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