January - March 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 June 30, 2017)
Alli (orlistat) capsules Xenical (orlistat) capsules, for oral use	Orlistat and neuropsychiatric adverse events	FDA is evaluating the need for regulatory action.
Cubicin (daptomycin for injection) for intravenous use Cubicin RF (daptomycin for injection) for intravenous use	Medication error	The container labels and carton labeling were revised. In addition, the “Dosage and Administration” section of the labeling was updated to better differentiate the two formulations. Cubicin labeling Cubicin RF labeling
Exjade (deferasirox) tablets, for oral suspension Jadenu (deferasirox) tablets, for oral use	Pediatric fever and dehydration	FDA is evaluating the need for regulatory action.
Gonadotropin-releasing hormone (GnRH) Agonists Lupron (leuprolide acetate) injection Lupron Depot PED (leuprolide acetate for depot suspension), injection, powder, lyophilized, for suspension Supprelin LA (histrelin acetate) subcutaneous implant Synarel (nafarelin acetate) nasal solution	Musculoskeletal and connective tissue pain and discomfort	FDA is evaluating the need for regulatory action.
Keppra (levetiracetam) tablets, for oral use Keppra (levetiracetam) extended-release tablets, for oral use Keppra (levetiracetam) oral solution Keppra (levetiracetam) injection, for intravenous use	Acute kidney injury and interstitial nephritis	The “Adverse Reactions; Postmarketing Experience” section of the labeling for Keppra and Keppra XR was updated to include acute kidney injury. Keppra XR labeling Keppra labeling (tablets & oral solution) Keppra labeling (injection)
Keytruda (pembrolizumab) for injection, for intravenous use Opdivo (nivolumab) injection, for intravenous use Yervoy (ipilimumab) injection, for intravenous use	Ocular toxicities including vision loss and retinal detachment	FDA is evaluating the need for regulatory action.
Kybella (deoxycholic acid) injection, for subcutaneous use	Injection site infection and necrosis	FDA is evaluating the need for regulatory action.
Methimazole tablets	Rhabdomyolysis in methimazole	FDA decided that no action is necessary at this time, based on available information.
Neulasta Onpro kit (pegfilgrastim) injection, for subcutaneous use	Device failure	FDA is evaluating the need for regulatory action.
Ofev (nintedanib) capsules, for oral use	Liver dysfunction	FDA is evaluating the need for regulatory action.
Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) tablets, for oral use Glyxambi (empagliflozin and linagliptin) tablets, for oral use Invokamet (canagliflozin and metformin hydrochloride) tablets, for oral use Invokamet XR (canagliflozin and metformin hydrochloride extended-release) tablets, for oral use Invokana (canagliflozin) tablets, for oral use Jardiance (empagliflozin) tablets, for oral use Synjardy (empagliflozin and metformin hydrochloride) tablets, for oral use Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets, for oral use Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) tablets, for oral use	Nephrolithiasis	FDA decided that no action is necessary at this time, based on available information.
Stelara (ustekinumab) injection, for subcutaneous use	Interstitial pneumonia	FDA is evaluating the need for regulatory action.
Tanzeum (albiglutide) for injection, for subcutaneous use Trulicity (dulaglutide), injection, for subcutaneous use	Serious hypersensitivity reactions	FDA is evaluating the need for regulatory action.
Uloric (febuxostat) tablets, for oral use	Drug reaction with Eosinophilia and Systemic Symptoms	FDA is evaluating the need for regulatory action.