2015 Drug Safety Communications

 

• FDA Drug Safety Communication: FDA eliminates the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing diabetes medicines 12/16/2015
• FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections 12/04/2015
• FDA Drug Safety Communication: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging 11/17/2015
• FDA Drug Safety Communication: FDA review finds long-term treatment with blood-thinning medicine Plavix (clopidogrel) does not change risk of death 11/06/2015
• FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson's disease drug entacapone 10/26/2015
• FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie 10/22/2015
• FDA Drug Safety Communication: FDA requires drug interaction studies with potassium-lowering drug Kayexalate (sodium polystyrene sulfonate) 10/22/2015
• FDA Drug Safety Communication: FDA cautions about dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam) 09/22/2015
• FDA Drug Safety Communication: FDA evaluating the risks of using the pain medicine tramadol in children aged 17 and younger 9/21/2015
• FDA Drug Safety Communication: FDA modifies monitoring for neutropenia associated with schizophrenia drug clozapine; approves new shared REMS program for all clozapine medicines 09/15/2015
• FDA Drug Safety Communication: FDA revises label of diabetes drug canagliflozin (Invokana, Invokamet) to include updates on bone fracture risk and new information on decreased bone mineral density 09/10/2015
• FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain 08/28/2015
• FDA Drug Safety Communication: FDA warns of severe adverse events with application of Picato (ingenol mebutate) gel for skin condition; requires label changes 8/21/2015
• FDA Drug Safety Communication: FDA warns about cases of rare brain infection with MS drug Gilenya (fingolimod) in two patients with no prior exposure to immunosuppressant drugs 08/04/2015
• FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor) 7/30/2015
• FDA Drug Safety Communication: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI) 07/27/2015
• FDA Drug Safety Communication: FDA warns about a serious lung condition in infants and newborns treated with Proglycem (diazoxide) 07/16/2015
• FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes 07/09/2015
• FDA Drug Safety Communication: FDA evaluating the potential risks of using codeine cough-and-cold medicines in children 07/01/2015
• FDA Drug Safety Communication: FDA reporting permanent skin color changes associated with use of Daytrana patch (methylphenidate transdermal system) for treating ADHD 06/24/2015
• FDA Drug Safety Communication: FDA determines 2013 labeling adequate to manage risk of retinal abnormalities, potential vision loss, and skin discoloration with anti-seizure drug Potiga (ezogabine); requires additional study 06/16/2015
• FDA Drug Safety Communication: FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam) 05/20/2015
• FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood 05/15/2015
• FDA Drug Safety Communication: FDA strengthens warnings and changes prescribing instructions to decrease the risk of serious allergic reactions with anemia drug Feraheme (ferumoxytol) 03/30/2015
• FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni) or Sovaldi in combination with another Direct Acting Antiviral drug 03/24/2015
• FDA Drug Safety Communication: FDA review of study sheds light on two deaths associated with the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) 03/23/2015
• FDA Drug Safety Communication: FDA updates label for stop smoking drug Chantix (varenicline) to include potential alcohol interaction, rare risk of seizures, and studies of side effects on mood, behavior, or thinking 03/09/2015
• FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use 03/03/2015
• FDA Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients 02/25/2015
• FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy 01/09/2015