2015 Drug Safety Communications

Current Drug Safety Communications More Drug Safety Communications

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