Safety Alerts & Recalls

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Latest Alerts

FDA Expands Use of Metformin-Containing Drugs in Certain Patients with Reduced Kidney Function
The U.S. Food and Drug Administration (FDA) has requested labeling changes regarding the recommendations for the use of metformin-containing medicines for diabetes in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. The new labeling will expand the use of metformin to include some patients with mild to moderate kidney function. The FDA was asked to review several medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin. The FDA has concluded from the review that metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function. They are also recommending that the measure of kidney function used to determine whether a patient can receive metformin be changed to one that provides a better estimate of kidney function in patients with kidney disease (i.e., glomerular filtration rate estimating equation (eGFR)). The prescribing information for all metformin-containing medicines will be updated with this new information. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm493244.htm
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FDA Advises Avoiding Use of Fluoroquinolone Antibiotics in Certain Uncomplicated Infections Due to Disabling Side Effects That Can Occur
The U.S. Food and Drug Administration (FDA) has issued a warning that the serious side effects associated with fluoroquinolone antibiotic drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should only be used for those who do not have other treatment options. An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system. Fluoroquinolone antibiotics include moxifloxacin (Avelox), ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), and ofloxacin. The drug labels and Medication Guides for these drugs will be updated to include this new safety information. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm500143.htm
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Date Published Title Drug Source
2016-05-02 FDA Expands Use of Metformin-Containing Drugs in Certain Patients with Reduced Kidney Function Glipizide with 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
2016-06-01 Clinical Trial Results Finds Increased Risk of Leg and Foot Amputations with Use of Canagliflozin (Invokana, Invokamet) Canagliflozin / Metformin FDA
2016-06-01 FDA Warns Ketoconazole Should Not Be Prescribed for Skin and Nail Infections Ketoconazole FDA
2016-06-01 FDA warns about rare but serious skin reactions with mental health drug olanzapine Fluoxetine with Olanzapine 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
2016-07-06 Safecor Health, LLC Recalls Single Lot of Donnatal Elixir Donnatal FDA
2016-07-06 AstraZeneca Pharmaceuticals LP Recalls Select Lots of Tudorza Pressair, 400 mcg per actuation Aclidinium FDA
2016-07-06 Teva Pharmaceuticals USA Recalls Single Lot of Nabumetone 750 mg Tablets Nabumetone FDA
2016-07-06 Teva Pharmaceuticals USA, Inc. a Singlel Lot of Paricalcitol Capsules, 1 mcg Paricalcitol FDA
2016-07-06 Virtus Pharmaceuticals, Llc Recalls Several Lots of Virt-Nate Prenatal/Postnatal, Prescription Folate-Containing Dietary Supplement Prenatal Vitamins FDA
2017-07-31 Increased Risk of Foot and Leg Amputations with Canagliflozin (Invokana, Invokamet, Invokamet XR) Canagliflozin / Metformin 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 FDA Warns about Rare but Serious Allergic Reactions with Chlorhexidine Gluconate Chlorhexidine FDA
2017-12-17 Köhler Pharma ruft eine Charge Lophakomp-B12-Depot 1000 µg Injektionslösung zurück Vitamin B AMK
2018-01-02 Puren Pharma ruft alle Chargen von Moxonidin-Actavis 0,3 mg und 0,4 mg Filmtabletten zurück Moxonidine AMK