Federal health officials confirmed 33 cases of a rare fungal eye infection across seven states on Thursday, stemming from products mixed in a Florida pharmacy that also mixed supplements that killed 21 elite polo horses in 2009.
The patients had all undergone some type of eye procedure, including surgery or injections. Twenty-three suffered some degree of vision loss and 24 patients had to undergo another eye surgery, according to a report from the Centers for Disease Control and Prevention.
Health officials traced many of the cases to a dye and an injection including triamcinolone and other products from Franck’s Compounding Lab in Ocala. The Food and Drug Administration tested unopened bottles and unused syringes of the dye collected, finding multiple bacterial and fungal species.
California health officials first alerted the CDC after nine patients developed the eye infection in March. Franck’s recalled dye lots that same month. A single lot of triamcinolone was recalled on Mar. 31.
CDC officials said the investigation to identify the root cause is ongoing and warned doctors and patients to stay away from “compounded products labeled as sterile from Franck’s,” according to the report.
The pharmacy has not recalled or halted production of other sterile compounded products, which chemotherapy and other injectables.
Pharmacy officials said in a statement they have conducted a thorough investigation and traced the cause of the contamination to a dye used in eye injections of triamcinolone and formulas containing that drug.
The pharmacy says it has resolved the issue and made several changes, including hiring a new pharmacist to oversee quality assurance. It says it has cooperated with federal health officials “in an effort to isolate the source of contamination and prevent future occurrences.”
Compounding is a process in which pharmacists mix drugs using bulk ingredients. Patients usually turn to compounders when they are allergic to inactive ingredients in FDA-approved medicines. They are also used when a patient needs a different dose or a different form of delivery — such as a cream, powder or injectable liquid — than what is commercially available.
State health officials said they can’t confirm whether they are investigating Franck’s or any pharmacy until 10 days after the alleged investigation and only if probable cause is found. If they do determine a pharmacy poses an immediate threat, the agency can immediately suspend the facility’s license.
Franck’s came under intense scrutiny in 2009 after 21 polo horses died before a championship match near West Palm Beach. The horses from the Venezuelan-owned Lechuza Caracas team had just been given a cocktail of vitamins and minerals compounded by the pharmacy on order from the team’s veterinarian.
Franck’s later acknowledged using too much selenium in the mix. Florida’s top veterinarian blamed the deaths on an overdose of the mineral often used to help horses recover from fatigue.
The horses’ owners have since filed a lawsuit against the pharmacy.
Following the horse deaths, the FDA accused Franck’s of illegally creating copies of similar drugs. The agency also says the pharmacy is mixing brews outside of federal guidelines and is compounding animal products from drugs that have not been approved for use in the U.S. Officials warned pharmacies can circumvent the statutory drug approval process by manufacturing drugs under the guise of pharmacy compounding.
The FDA says Franck’s was also warned in 2005, four years before the horses’ deaths, that it was compounding animal drugs illegally. The agency warned the pharmacy again in December 2009, according to the complaint.
But a federal court disagreed with the FDA in 2011, ruling the agency did not have jurisdiction over the longstanding practice of pharmacists filling veterinary prescriptions for animals by compounding from bulk substances.
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This Week’s Celebrity Instagrams (11/26-12/2)
30 photos Launch gallery
1. Little Legend and Puddy 😍😍😍😍
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2. "You on point Phife?" "all the time,Tip". 💥 #bannedfromnormal
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3. Vegan! The Impossible burger at Crossroads
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4. Lawrence #BeforeandAfterEpisodes 1-4: 184lbs 13% body fatEpisode 8: 196lbs 8% body fat S/O @coachdaveboxing with the works outs and @kildareriordan with the nutrition
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5. Jus haaaanngin out
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6. Meanwhile back at home in Atlanta GA someone mad they not on the 🛳. 😳
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7. No limits... Photo cred: Chris Bridges @ludacris
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8. new new
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9. Apparently my 260lbs is too much for the actual vines in the Hawaiian jungles to hold me without breaking and me falling hundreds of feet. So for safety purposes, I'm forced to swing thru #Jumanjj on wires strong enough to hold 12 adult buffaloes and 1 adult Rock. #OnSet #Jumanji #IronicallyIEatBuffaloDailyForLunch #MoreManThanNatureKnowsWhatToDoWith
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10. hey ma! 🎎#wcw 💙
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11. Surprise visit to our factories!!! #GoodAmerican #USA
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13. Peachy Keen 🔥✨⚡️
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14. If this don't look thankful I don't know what does. Happy Thanksgiving to you and yours. #UltraBlessed #24kMagic #SweetPotatoFly
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15. Late nights @nbcmarlon with the writers... we in here!!!
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16. There goes my baaaaaaaaabbbbyyyyy #QueenKingMagic!!! We're up to something! Ira BIG!!! Stay out our buisness -
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17. You want to win every game you play but when you come home to these faces... who cares. #ILoveYouGirls best part of my day, everyday!
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18. Steady,steady..... full size jenga.. "I got this one "???? Or do I ?
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19. Cornrows kind of day 😉@dontaysavoy2 you convinced me and I love. ❤️️
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20. #BrotherlyLove #tbt
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22. #basel #TeamLOVE @kingcombs
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23. Just introduced a special screening of @directher 's groundbreaking (must see) documentary @13thfilm with my brother @themichaelealy | @unitedblackout #blackoutblackfriday
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24. Me & Vanessa Williams giving #DuckLips #Pose on the set of #DaytimeDivas @vh1 - Coming Soon to a tv near you. Lol. - My make up done by @makeupsurgeon
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25. This picture just makes me wanna praise the Lord, you hear me!!!!!! Yes Lord brotha #TEDDYCAMPBELL What a #man !!! You are everything right on this picture husband ......... #gorgeous #stylish #classy #strong #masculine #king #sexy #debonair #gentlemenstyle And that #bible in your hand just seals the deal for me (probably cause i know that, that is what helped you become just as amazing as you look😘). While my heart and mind experiences the goodness of God at #church on Sundays, my eyes experiences the goodness of Teddy😍. Amen somebody🙌🏽. "Bless the Lord oh my soul and all that is within me bless his holy name" #myman #myhusband #goodman #blackman #dapperman #godlyman #goodfather #mybestfriend
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26. Yesterday was my mama's 53rd birthday!!!!! Got to celebrate with her all day. If this is what I have to look forward to I can't wait. Looking like a soft bucket a cocoa butter. Yaaaaaaaaaas! 😍😍😍 love you mommy!
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27. "Shout out to @PureAtlanta for getting the family right"....I'm loving this jogger. 😍😍
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28. This pic warms my heart ❤️ #myLogiebeans and aunt aunt umba @itowandabraxton 😘
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29. You will always be my baby😜. #HappyBirthdayReginae #mybaby18
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30. GC "Gods Child" Red on Red SweatSuit available now at www.MonicaApparel.com ... Take Your Crown wherever you go!! I'm pictured in a Medium... Go to the site now for other options ... cc: @trukernell
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