Soon after FDA warned about a potential increased risk of foot and leg amputations with the use of the type 2 diabetes medication canagliflozin (Invokana and Invokamet, Janssen Biotech), the agency strengthened the existing warning about the risk of acute kidney injury with Invokana and Invokamet, as well as dapagliflozin (Farxiga and Xigduo XR, AstraZeneca).
Teva Pharmaceuticals is temporarily suspending sales and distribution of its sumatriptan iontophoretic transdermal system (Zecuity) patch for migraines, after FDA said it is investigating the risk of serious burns with the use of the patch.
FDA issued a new warning about potentially serious side effects associated with fluoroquinolone antibacterial drugs. Affected brands include Cipro, Levaquin, Avelox, Factive and Moxaflaxacin injection, as well as the generic Ofloxacin.
The FDA has strengthened its warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density.
FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS).
FDA issued a drug safety warning that there have been 50 reports of medication errors because of confusion between the antidepressant Brintellix (vortioxetine) and the antiplatelet agent Brilinta (ticagrelor).