2016 Drug Safety Communications

Current Drug Safety Communications More Drug Safety Communications

• 12-16-2016: FDA revises description of mental health side effects of the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) to reflect clinical trial findings 
• 12-14-2016: FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women 
• 12-12-2016: Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer 
• 10-04-2016: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C 
• 08-31-2016: FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning 
• 07-26-2016: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects 
• 06-14-2016: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR) 
• 06-07-2016: FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse 
• 06-06-2016: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin 
• 06-02-2016: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch 
• 05-19-2016: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death 
• 05-18-2016: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate 
• 05-12-2016: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together 
• 05-10-2016: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax) 
• 05-03-2016: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada) 
• 05-02-2016: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor) 
• 04-26-2016: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy 
• 04-08-2016: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function 
• 04-05-2016: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin 
• 03-22-2016: FDA warns about several safety issues with opioid pain medicines; requires label changes 
• 01-04-2016: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved