Safety Alerts & Recalls

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FDA Warns about Rare but Serious Allergic Reactions with Chlorhexidine Gluconate
The U.S. Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with the widely used skin cleanser products containing chlorhexidine gluconate. Chlorhexidine gluconate is a widely used antiseptic. It is mainly available in over-the-counter (OTC) products used to clean and prepare the skin before surgery and before injections in order to help reduce bacteria that potentially can cause skin infections. Although rare, the number of reports of serious allergic reactions to these products has increased over the last several years. As a result, we are requesting the manufacturers of over-the-counter (OTC) antiseptic products containing chlorhexidine gluconate to add a warning about this risk to the Drug Facts labels. Prescription chlorhexidine gluconate mouthwashes and oral chips used for gum disease already contain a warning about the possibility of serious allergic reactions in their labels. The following products contain chlorhexidine gluconate: --- OTC products are available as topical solutions, washes, sponges, and swabs. They are marketed under brand names such as Avagard, Bioscrub, Brian Care, CHG Scrub, ChloraPrep, CIDA-Stat, Dyna-Hex, Exidine, Hibiclens, Hibistat, Pharmaseal Scrub Care, and Prevantics. They are also sold as generic products, including store brands. --- Prescription oral rinse solution to treat gingivitis. It is marketed under the brand name Peridex as well as many generic brands such as Periogard, Oris, PerioRx, and Paroex. --- Prescription oral chip under the brand name Periochip, which is inserted between the gums and teeth to treat periodontal disease. --- Some medical devices such as dressings and intravenous lines also contain chlorhexidine gluconate. For more information, please visit:
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FDA Warns about Increased Risk of Serious Pancreatitis with Irritable Bowel Drug Viberzi (eluxadoline) in Patients without a Gallbladder
The U.S. Food and Drug Administration (FDA) is warning that Viberzi (eluxadoline) should not be used in patients who do not have a gallbladder. Viberzi is a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D). An FDA review found these patients who take Viberzi and who do not a gallbladder have an increased risk of developing serious pancreatitis that could result in hospitalization or death. Pancreatitis may be caused by spasm of a certain digestive system muscle in the small intestine. The FDA is working with the Viberzi manufacturer, Allergan, to address these safety concerns. For more information, please visit:
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Date Published Title Drug Source
2017-07-31 FDA Warns about Rare but Serious Allergic Reactions with Chlorhexidine Gluconate Chlorhexidine FDA
2017-07-31 FDA Warns about Increased Risk of Serious Pancreatitis with Irritable Bowel Drug Viberzi (eluxadoline) in Patients without a Gallbladder Eluxadoline FDA
2017-07-31 Increased Risk of Foot and Leg Amputations with Canagliflozin (Invokana, Invokamet, Invokamet XR) Canagliflozin / Metformin FDA
2016-07-06 Virtus Pharmaceuticals, Llc Recalls Several Lots of Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement Prenatal Vitamins FDA
2016-07-06 Teva Pharmaceuticals USA, Inc. a Singlel Lot of Paricalcitol Capsules, 1 mcg Paricalcitol FDA
2016-07-06 Teva Pharmaceuticals USA Recalls Single Lot of Nabumetone 750 mg Tablets Nabumetone FDA
2016-07-06 AstraZeneca Pharmaceuticals LP Recalls Select Lots of Tudorza Pressair, 400 mcg per actuation Aclidinium FDA
2016-07-06 Safecor Health, LLC Recalls Single Lot of Donnatal Elixir Donnatal FDA
2016-07-06 Pfizer Inc Recalls Single Lot of Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz. Bottle Guaifenesin with Dextromethorphan FDA
2016-06-01 FDA warns about rare but serious skin reactions with mental health drug olanzapine Fluoxetine with Olanzapine FDA
2016-06-01 FDA Warns Ketoconazole Should Not Be Prescribed for Skin and Nail Infections Ketoconazole FDA
2016-06-01 Clinical Trial Results Finds Increased Risk of Leg and Foot Amputations with Use of Canagliflozin (Invokana, Invokamet) Canagliflozin / Metformin FDA
2016-06-01 FDA Advises Avoiding Use of Fluoroquinolone Antibiotics in Certain Uncomplicated Infections Due to Disabling Side Effects That Can Occur Gemifloxacin FDA
2016-05-02 FDA Expands Use of Metformin-Containing Drugs in Certain Patients with Reduced Kidney Function Glipizide with Metformin FDA
2016-05-02 FDA Is Reviewing a Study Linking Fluconazole Use and Risk of Miscarriage Fluconazole FDA
2016-02-03 Los Profesionales Sanitarios Informados: Viekirax (Ombitasvir, Paritaprevir, Ritonavir) No Recomendado En Pacientes Con Determinados Problemas En El Hígado AEMPS
2015-11-12 FDA Completes Review of Blood-Thinning Medicine Plavix (Clopidogrel) Clopidogrel FDA
2015-08-28 FDA Warns About Possible Side Effect of DPP-4 Inhibitors Sitagliptin FDA
2015-08-25 Allergan Issues Voluntary Recall of Select Lots Of REFRESH Lacri-Lube, REFRESH P.M., FML, and Blephamide Over Safety Concerns Fluorometholone FDA
2015-05-27 FDA Warns About Possible New Side Effect of SGLT2 Inhibitors Canagliflozin / Metformin FDA
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