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