Safety Alerts & Recalls

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Latest Alerts

TNF Blockers Increase the Risk of Fungal Infections
The FDA recently released an alert to remind patients that tumor necrosis factor-alpha blockers (TNF blockers), such as CERTOLIZUMAB (CIMZIA), may increase your risk for infections. This can include serious infections caused by viruses, fungi, or bacteria, including tuberculosis (TB). The FDA is especially concerned that serious fungal infections are not being recognized in patients taking TNF blockers and that this may result in delays in the correct treatment. For more information please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109340.htm
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New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers
The FDA is requiring the manufacturers of tumor necrosis factor (TNF) blockers to update the Boxed Warning in the prescribing information to warn of an increased risk of lymphoma and other cancers in children and adolescents treated with TNF blockers. This new Boxed Warning is an addition to the existing Boxed Warning relating to the risk of potentially fatal infections, including tuberculosis, in all patients who use TNF blockers. The currently FDA approved TNF blockers include adalizumab (marketed as Humira), certolizumab (marketed Cimzia), etanercept (marketed Enbrel), golimumab (marketed as Simponi), and infliximab (marketed as Remicade). TNF blockers are approved for the treatment of one or more of a number of immune system diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis. In addition to the updated Boxed Warning, the FDA is requiring several other changes to the prescribing information for TNF blockers, including: 1) An update to the Warnings section describing reported cases of leukemia in adults, adolescents, and children 2) An update to the Adverse Events section to include information on reported cases of new-onset psoriasis 3) An update to the Medication Guide for these medications to provide this new safety information to patients who receive prescriptions for TNF blockers This new safety information is based on the FDA's completed analysis of TNF blockers which included reports of lymphoma and other cancers in children and adolescents, post-marketing leukemia reports in all patients, as well as a post-marketing evaluation of new-onset psoriasis in patients treated with these drugs. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174474.htm
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Date Published Title Drug Source
2008-09-04 TNF Blockers Increase the Risk of Fungal Infections Certolizumab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Certolizumab FDA
2011-04-08 FDA Warns Consumers About Serious Side Effect Linked To the Use of Benzocaine Found in Over-the Counter Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and Other Store Brands FDA
2010-04-13 Voluntary Recall of Several Zyrtec Products Cetirizine Manufacturer
2010-05-03 Voluntary Recall of Certain Liquid Children's and Infants' Tylenol Motrin, Zyrtec, and Benadryl Products Cetirizine Manufacturer
2010-05-06 What Consumers Need to Know About Recalled Liquid Products for Children Cetirizine Manufacturer
2012-10-30 Sandoz Inc. Recalls Several Lots of Children's Cetirizine Chewable Tablets 5 mg Cetirizine FDA
2012-09-17 Natural Essentials Recalls Several Lots of Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06% Cetylpyridinium FDA
2008-08-05 Generic Manufacturer Recalls Several Drug Products Manufacturer
2008-08-05 Generic Manufacturer Recalls Several Drug Products Chlordiazepoxide with Clidinium Bromide Manufacturer
2011-08-16 Hi-Tech Pharmacal Recalls Single Lot of Chlorhexidine Gluconate Oral Rinse, 0.12% Chlorhexidine FDA
2011-08-16 Kimberly-Clark Corp. Recalls Several Lots of KimVent Oral Care Kits with Chlorhexidine Gluconate Solution 0.12% Chlorhexidine FDA
2013-02-03 Novartis Recalls Several Lots of Triaminic® and Theraflu Warming Relief® Syrups Manufacturer
2008-10-10 Important Information About Safe Use of Children's Cough and Cold Medicine Chlorpheniramine Manufacturer
2008-06-17 New Boxed Warning on Older Class of Antipsychotic Drugs Chlorpromazine FDA
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Chlorpromazine MediGuard CRT
2008-08-04 Generic Manufacturer Recalls Several Drug Products Chlorzoxazone Manufacturer
2011-05-02 Teva Recalls Single Lot of Chlorzoxazone Tablets, 500 mg Chlorzoxazone FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Manufacturer
2011-12-14 FDA Warns HCG Diet Products Are Illegal FDA
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