April - June 2017 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Product Name: Trade (Active Ingredient) or Product Class	Potential Signal of a Serious Risk / New Safety Information	Additional Information (as of September 30, 2017)
Adrenalin® (epinephrine injection), for intramuscular and subcutaneous use	Adrenaline (epinephrine) injection and wrong drug errors	FDA published a Dear Healthcare Provider Letter (DHCP letter) on its website to communicate the change in formulation and removal of the mydriasis indication for Adrenalin®. Adrenalin® DHCP letter The carton/container labeling for Adrenalin® was updated to remove the mydriasis indication. Adrenalin® package insert labeling
Aldara® (imiquimod) cream, 5%, for topical use only Zyclara (imiquimod) cream, 3.75%, for topical use Zyclara (imiquimod) cream, 2.5%, for topical use	Drug induced vitiligo-like depigmentation	FDA is evaluating the need for regulatory action.
Ameluz® (aminolevulinic acid hydrochloride) gel, 10%, for topical use	Transient global amnesia	The “Warnings and Precautions,” “Adverse Reactions,” and “Patient Counseling” sections of the labeling for Ameluz were updated to include transient amnestic episodes. Ameluz® labeling
Campath (alemtuzumab) injection, for intravenous use Lemtrada (alemtuzumab) injection, for intravenous use	Acute acalculous cholecystitis	FDA is evaluating the need for regulatory action.
Carafate® (sucralfate) oral suspension	Medication error: administration error	The labeling for Carafate® was updated to revise the name of the drug from “Carafate suspension” to “Carafate oral suspension.” The labeling for Carafate® was changed to include warnings of fatal complications with inappropriate intravenous administration of Carafate® oral suspension. Carafate® labeling
Coartem (artemether/lumefantrine) tablets	Hemolytic anemia	FDA is evaluating the need for regulatory action.
Epipen® (epinephrine injection, USP), Auto-injector 0.3 mg, for intramuscular or subcutaneous use Epipen® Jr (epinephrine injection, USP) Auto-injector 0.15 mg, for intramuscular or subcutaneous use	Device failure	FDA issued a warning letter to Meridian Medical Technologies, Inc., summarizing significant violations of current good manufacturing practice requirements for combination products. Epipen® Warning Letter
Dipeptidyl peptidase-4 inhibitors Glyxambi (empagliflozin and linagliptin) tablets, for oral use Janumet (sitagliptin and metformin hydrochloride) tablets, for oral use Janumet XR (sitagliptin and metformin hydrochloride extended-release) tablets, for oral use Januvia (sitagliptin) tablets, for oral use Jentadueto (linagliptin and metformin hydrochloride) tablets, for oral use Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets, for oral use Kazano (alogliptin and metformin hydrochloride) tablets, for oral use Kombiglyze XR (saxagliptin and metformin hydrochloride extended-release) tablets, for oral use Nesina (alogliptin) tablets, for oral use Onglyza (saxagliptin) tablets, for oral use Oseni (alogliptin and pioglitazone) tablets, for oral use Qtern (dapagliflozin and saxagliptin) tablets, for oral use Tradjenta (linagliptin) tablets, for oral use	Rhabdomyolysis	FDA is evaluating the need for regulatory action.
Gilenya® (fingolimod) capsules, for oral use	Rebound multiple sclerosis upon discontinuation of fingolimod	FDA is evaluating the need for regulatory action.
Gleevec® (imatinib mesylate) tablets, for oral use	Decline in renal function	The “Warning and Precautions” section of the labeling for Gleevec® was updated to include renal toxicity. Gleevec® labeling
GlucaGen (glucagon [rDNA origin] for injection), for subcutaneous, intramuscular, or intravenous use Glucagon for injection, for subcutaneous, intramuscular, or intravenous use	Necrolytic migratory erythema	FDA is evaluating the need for regulatory action.
Keytruda® (pembrolizumab) injection, for intravenous use Opdivo® (nivolumab) injection, for intravenous use	Complications of allogeneic hematopoietic stem cell transplantation	FDA is evaluating the need for regulatory action.
Keytruda® (pembrolizumab) injection, for intravenous use	Stevens-Johnson syndrome and toxic epidermal necrolysis	The “Warning and Precautions” section of the labeling for Keytruda was updated to include Stevens-Johnson syndrome and toxic epidermal necrolysis. Keytruda® labeling
Pomalyst® (pomalidomide) capsules, for oral use	Ischemic colitis	FDA decided that no action is necessary at this time based on available information.
Proton Pump Inhibitors Aciphex (rabeprazole sodium) delayed-release tablets, for oral use Esomeprazole strontium delayed-release capsules, for oral use Nexium (esomeprazole magnesium) delayed-release capsules, for oral use Nexium (esomeprazole magnesium) for delayed-release oral suspension Nexium I.V. (esomeprazole sodium) for injection, for intravenous use Prevacid (lansoprazole), delayed-release capsules, for oral use Prevacid Solutab (lansoprazole) delayed-release orally disintegrating tablets Prilosec (omeprazole) delayed-release capsules Prilosec (omeprazole) delayed-release oral suspension Protonix (pantoprazole sodium) delayed-release tablets, for oral use Protonix (pantoprazole sodium) for delayed-release oral suspension Protonix IV (pantoprazole sodium) for injection, for intravenous use	Polyps of stomach and duodenum	FDA is evaluating the need for regulatory action.
Proton Pump Inhibitors Aciphex (rabeprazole sodium) delayed-release tablets, for oral use Esomeprazole strontium delayed-release capsules, for oral use Nexium (esomeprazole magnesium) delayed-release capsules, for oral use Nexium (esomeprazole magnesium) for delayed-release oral suspension Nexium I.V. (esomeprazole sodium) for injection, for intravenous use Prevacid (lansoprazole), delayed-release capsules, for oral use Prevacid Solutab (lansoprazole) delayed-release orally disintegrating tablets Prilosec (omeprazole) delayed-release capsules Prilosec (omeprazole) delayed-release oral suspension Protonix (pantoprazole sodium) delayed-release tablets, for oral use Protonix (pantoprazole sodium) for delayed-release oral suspension Protonix IV (pantoprazole sodium) for injection, for intravenous use	Chronic kidney disease/ acute kidney injury	FDA decided that no action is necessary at this time based on available information.
Repatha (evolocumab) injection, for subcutaneous use	Skin and subcutaneous tissue bacterial infections	FDA is evaluating the need for regulatory action
Taxotere (docetaxel) injection concentrate, intravenous infusion	Docetaxel and neutropenic enterocolitis	FDA is evaluating the need for regulatory action.
Uvadex® (methoxsalen) injection, solution	Embolism and thrombosis	FDA is evaluating the need for regulatory action.