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FDA Medwatch Alert: Brilliant Blue G: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases
Posted 19 Mar 2012 by Drugs.com
ISSUE: FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgeries. Clinicians in several states reported the adverse events. FDA, along with CDC and local and state public health agencies, are actively investigating these adverse events. BACKGROUND: The BBG was supplied by Franck’s Compounding Lab, Ocala, Florida. Franck’s Pharmacy issued a recall on March 9, 2012, of all lots of Brilliant Blue G and issued a recall letter (link below). Brilliant Blue G is not an approved drug in the U.S. RECOMMENDATION: Immediately quarantine and return any remaining Brilliant Blue G product. This includes all lots of Brilliant Blue G received from Franck’s Pharmacy. FDA requests that practitioners report to MedWatch any cases of endophthalmitis, fungal or bacterial, that occurred within the last six months, associated with ... Read more
Related support groups: Ophthalmic Surgery
Mobius Therapeutics Receives Final FDA Approval for New Glaucoma Drug Mitosol
Posted 9 Feb 2012 by Drugs.com
ST. LOUIS, Feb. 9, 2012 /PRNewswire/ – Mobius Therapeutics, LLC, a St. Louis-based ophthalmic company, has received final approval from the U.S. Food and Drug Administration for the platform product, Mitosol. This initial indication is for the use of Mitosol in glaucoma surgery. With FDA approval, Mobius Therapeutics can start marketing and production efforts for Mitosol immediately. "The approval of Mitosol for use in glaucoma surgery represents the culmination of more than five years of work on the part of Mobius Therapeutics," said Ed Timm, President of Mobius Therapeutics. "It will provide surgeons, hospitals, and patients with enhanced convenience, safety, and consistency in the surgical treatment of glaucoma." Glaucoma is the second-leading cause of blindness in the United States. It is treated progressively, beginning with pharmaceuticals, then office intervention and finally ... Read more
Related support groups: Glaucoma, Glaucoma (Open Angle), Glaucoma/Intraocular Hypertension, Ophthalmic Surgery, Glaucoma (Narrow Angle), Glaucoma with Pupillary Block
Eye Condition May Alter Corneal Transplant Results
Posted 1 Jul 2010 by Drugs.com
THURSDAY, July 1 – Corneal transplant rejection is more likely to occur in people who have abnormal vessel growth in their eyes before undergoing the surgery, a team of German and British researchers reports. However, people with the condition – known as neovascularization – might improve their chances of a successful transplant, the researchers say, if they were given growth-inhibiting drugs beforehand. Known as antiangiogenics, such drugs include bevacizumab and ranibizumab. In addition, other drugs that work at the genetic level to control such problematic growth are currently under study. "The presence of corneal neovascularization before surgery makes it about 30 percent more likely that the transplant will fail and more than doubles the risk of graft rejection," researcher Dr. Claus Cursiefen said in a news release from the American Academy of Ophthalmology. "We also found that ... Read more
Related support groups: Ophthalmic Surgery
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Related Condition Support Groups
Postoperative Ocular Inflammation, Corneal Refractive Surgery, Ophthalmic Surgical Staining, Ophthalmic Viscoelastic Agent, Surgery
Related Drug Support Groups
Zymar, Vigamox, Ciloxan, Besivance, Ocuflox, Navstel, besifloxacin, Akten, Chibroxin, Iquix, Quixin, irrigation, intraocular