Food & Drug Administration of United States has released a drug safety alert for Moxifloxacin to bring awareness to health care professionals with this safety information.
Moxifloxacin is quinoline antibiotic which inhibits the growth of bacteria. It is used in the treatment of various bacterial infections. Moxifloxacin is available in two brand names in USA-Moxeza and Vigamox which are approved by FDA only for topical administration (Intraocular administration is an off-label use). As per some published medical literature articles, moxifloxacin which is administered intraocularly showed effectiveness for the treatment of endophthalmitis (a bacterial infection inside the eye which involves purulent inflammation of the intraocular fluids (vitreous and aqueous humor). However, there are no clinical studies conducted to support and demonstrate safety and efficacy for moxifloxacin in treating endophthalmitis.
Ophthalmologists do often administer moxifloxacin (via topical or intraocular) and other anti-infective agents to reduce the incidence of postoperative endophthalmitis. Endophthalmitis occurs following cataract surgery at a low incidence. No medication was approved by FDA currently for the treatment of endophthalmitis.
Ophthalmologists use moxifloxacin ophthalmic solutions (for topical), as the starting material to prepare moxifloxacin drugs for use during intraocular procedures.
FAERS (FDA Adverse event reporting system) is the adverse drug reaction reporting database which collects and stores safety information pertaining to medicinal products received from pharmaceutical companies (drug manufacturers having marketing authorization in United States) and also directly from public (both health care professionals and consumers-patient/patient’s care providers). FDA identified a significant rise in influx of case reports of TASS (Toxic Anterior Segment Syndrome) associated with the use of both moxifloxacin and moxifloxacin compounded drugs. TASS is an acute postoperative inflammatory reaction.
FDA identified a total of 29 case reports relevant to this safety concern and moxifloxacin retrieved through a search in FAERS for all reports databased since 19-Dec-2019. The route used for administration of moxifloxacin is ‘intraocular’. In 19 case reports, it was reported that moxifloxacin was administered following cataract surgery and for other 10 reports the type of ophthalmic surgery was not specified. Most of the cases were reported by a health care professional and did not reported the use of concomitant intraocular drugs or drugs containing multiple active ingredients.
Analysis of 10 case reports for Drug-ADR pair-Moxifloxacin-TASS
Temporal relationship (for onset of TASS): within one week of intraocular administration of compounded drug containing moxifloxacin.
Dechallenge positive: TASS events were resolved following the treatment discontinuation.
Rechallenge positive: TASS events reappeared after reintroduction of treatment during subsequent surgical procedures.
Advise to health care professionals:
To be aware of this alert associated with intraocular administration of this drug also to carefully consider the concentration and inactive ingredients before administering through intraocular route.
Health care professionals and consumers are advised to report any new or already known or suspicious adverse experiences or reactions or quality issues with the use of medicinal products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and voluntarily submit the report Online.
- Regular Mail or Fax: Download form FDA’s MedWatch zone, or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800- FDA-0178