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FDA Updates Labels for Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab)
The U.S. Food and Drug Administration (FDA) announced that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNF-alpha) blockers has been updated to include the risk of infection from two additional types bacteria, Legionella and Listeria. The class of TNFα blockers are used to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and/or juvenile idiopathic arthritis. The class of TNF-alpha blockers are biologic products that include Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab). Since TNF-alpha blockers suppress the immune system, patients who take these biologic products are at increased risk of serious infections. These serious infections are caused by bacteria, fungi, viruses, and parasites that have spread throughout the body, and can include tuberculosis (TB) and histoplasmosis. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm270849.htm
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FDA Warns of Infection Risk from Repackaged Avastin Injections For Eye Disease
The Food and Drug Administration (FDA) has alerted healthcare providers that repackaged injections of Avastin (bevacizumab) used for eye disease have caused serious eye infections in the Miami, Florida area. Avastin solution for intravenous infusion is approved for the treatment of various types of cancers. Some physicians also prescribe Avastin off-label for the treatment of wet age-related macular degeneration, although Avastin is not currently approved for this indication. Lucentis (ranibizumab injection) has been approved by the FDA for wet age-related macular degeneration. Since Avastin is FDA not approved for wet age-related macular degeneration, it is not manufactured in single-use doses for injection into the eye. Compounding pharmacies often repackage the Avastin vials used for infusions into individual 1 mL single-use syringes to be injected into the eye to treat wet age-related macular degeneration. The Florida Department of Health (DOH) has notified the FDA about reports of Streptococcus endophthalmitis infections in three clinics following injection of repackaged Avastin into the eye. Investigators traced the tainted injections to a single pharmacy located in Hollywood, Florida. To date, the FDA is aware of at least twelve patients in at least three of these Miami clinics who had eye infection. While all of these patients had problems with their vision prior to their injections with Avastin, some of these patients lost all remaining vision in that eye due to the infection. Five additional cases of vision loss possibly related to Avastin injections into the eye have been reported in Los Angeles, California. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm270296.htm and http://www.nytimes.com/2011/09/02/business/more-reports-of-avastin-causing-blindness.html?_r=1
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Date Published Title Drug Source
2011-09-07 FDA Updates Labels for Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) Etanercept FDA
2011-09-07 FDA Warns of Infection Risk from Repackaged Avastin Injections For Eye Disease Bevacizumab FDA
2011-09-01 FDA Warns: Serious Allergic Reactions Reported with the Use of Saphris (Asenapine Maleate) Asenapine FDA
2011-09-01 FDA Adds Warning of Risk of Kidney Failure With Use of Reclast (Zoledronic Acid) Zoledronic Acid FDA
2011-08-27 Abnormal Heart Rhythms Associated with High Doses of Citalopram (Celexa) Citalopram FDA
2011-08-16 McNeil Recalls Tylenol Cold Multi-Symptom Nighttime Rapid Release Gelcaps Tylenol Cold Multisymtom Plus Coug Manufacturer
2011-08-16 Taro Pharmaceuticals Recalls Select Lots of Fluorouracil Topical Cream, 5% Fluorouracil FDA
2011-08-16 Dr. Reddy's Laboratories Inc. Recalls Simvastatin Tablets Due To Musty Smell Simvastatin FDA
2011-08-16 Teva Pharmaceuticals Recalls Several Lots of Risperidone 0.25 mg, 0.5 mg, 1 mg, 2 mg and 3 mg Tablets Risperidone FDA
2011-08-16 Kimberly-Clark Corp. Recalls Several Lots of KimVent Oral Care Kits with Chlorhexidine Gluconate Solution 0.12% Chlorhexidine FDA
2011-08-16 Hi-Tech Pharmacal Recalls Single Lot of Chlorhexidine Gluconate Oral Rinse, 0.12% Chlorhexidine FDA
2011-08-16 Novartis Pharmaceuticals Recalls Single Lot of Enablex Darifenacin FDA
2011-08-16 Corepharma Recalls Several Lots of Potassium Citrate Extended-Release Tablets Potassium Citrate FDA
2011-08-05 FDA Updates Safety Review For Recombinant Human Growth Hormone (Somatropin) Somatropin FDA
2011-08-03 FDA Warns: Risk of Birth Defect with Long-Term, High-Dose Fluconazole During Pregnancy Fluconazole FDA
2011-08-03 Hetero Drugs Limited Recalls Single Lot of Torsemide tablets, 100 mg Torsemide FDA
2011-08-03 Vintage Pharmaceuticals Recalls Single Lot of Q-Tapp DM Liquid Poly-Histine-DM FDA
2011-08-03 Vintage Pharmaceuticals Recalls Select Lots of CODITUSS DM Liquid FDA
2011-08-03 Vintage Pharmaceuticals Recalls Select Lots of Q-Tussin DM and Iophen DM-NR Liquid Guaifenesin with Dextromethorphan FDA
2011-08-02 FDA Report Cites Customer Complaints of Shrink Wrap Found in Vaccine Vials Human Papilloma Virus Quadrivalent (Types 6, 11, 16, and 18) Vac FDA
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