April – June 2015 | 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 October 25, 2023)
Acetaminophen	Pediatric ingestion errors	Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen_Final Guidance (8/4/15)
Bloxiverz (neostigmine methylsulfate) injection Vazculep (phenylephrine HCl) injection	Potential product selection errors	Carton and vial labeling designs were revised to better differentiate Vazculep from Bloxiverz. Vazculep Health Care Provider Letter (May 2015)
Brintellix (vortioxetine) tablet Brilinta (ticagrelor) tablet	Brand name confusion	Updated Brintellix & Brilinta Drug Safety Communication (7/30/15) FDA approved a brand name change for the antidepressant Brintellix (vortioxetine) in May 2016 to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medicine Brilinta (ticagrelor). The new brand name of vortioxetine is Trintellix.
Calcium carbonate	Milk-alkali syndrome (hypercalcemia)	Updated FDA decided that no action is necessary at this time based on available information.
Daliresp (roflumilast) tablet	Gynecomastia	“Postmarketing Experience” section updated to include gynecomastia. Daliresp Labeling
Daytrana (methylphenidate) patch	Chemical leukoderma	The “Warnings and Precautions” section of the labeling was updated to include chemical leukoderma. Daytrana Labeling Daytrana Drug Safety Communication (6/24/15)
Iodinated Contrast Media: Cholografin meglumine (iodipamide meglumine, 52%) injection Conray 43 (iothalamate meglumine, 43%) injection Conray 30 (iothalamate meglumine, 30%) injection Cystografin dilute (diatrizoate meglumine, 18%) injection Isovue (iopamidol) injection (several strengths) Omnipaque (iohexol) injection Optiray (ioversol) injection (several strengths) Oxilan (ioxilan) injection Ultravist (iopromide) injection (several strengths) Visipaque (iodixanol) injection (several strengths)	Severe cutaneous adverse reactions including: Stevens-Johnson Syndrome (SJS) Toxic Epidermal Necrolysis (TEN) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Acute Generalized Exanthematous Pustulosis (AGEP) associated with iodinated contrast media	Updated The Warnings and Precautions and Adverse Reactions sections of the iodinated contrast media product labeling were updated in April 2017 to include the risk of Severe Cutaneous Adverse Reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).  Optiray Label
Over-the-counter chlorhexidine gluconate topical products: Bactoshield sponge BD E-Z scrub solution Chloraprep One-Step (with alcohol) solution Chlorhexidine gluconate cloth Dyna-Hex 75 antiseptic handwash solution Hibiclens solution Hibistat (with alcohol) solution Exidine solution Exidine aerosol, metered, topical Prevantics Maxi Swabstick (with alcohol) solution Scrub Care Exidine-2-CHG solution Scrub Care solution Scrub-Stat solution	Hypersensitivity/anaphylaxis	Updated FDA Drug Safety Communication (2/2/2017)  The Warnings section of the over-the-counter chlorhexidine gluconate topical products labeling was updated in 2017 to include an Allergy Alert.
Proglycem (diazoxide) capsules, suspension	Pulmonary hypertension	The “Warnings,” “Precautions,” and “Adverse Reaction” sections of the labeling were updated to include pulmonary hypertension. Proglycem Labeling Proglycem Drug Safety Communication (7/16/15)
SGLT2 inhibitors: Farxiga (dapagliflozin) tablet Glyxambi (empagliflozin/linagliptin) tablet Jardiance (empagliflozin) tablet Invokamet (canagliflozin/metformin HCl) tablet Invokana (canagliflozin) tablet Synjardy (empagliflozin/metformin HCl) tablets Xigduo XR (dapagliflozin/metformin HCl) extended release tablet	Stroke and thromboembolic events	Updated FDA decided that no action is necessary at this time based on available information.
Tramadol hydrochloride (HCl) products: Conzip (tramadol HCl) extended-release capsule Ultracet (tramadol HCl/acetaminophen) tablet Ultram (tramadol HCl) tablet Ultram ER (tramadol HCl) extended-release tablet	Respiratory depression and CYP2D6 ultra-rapid metabolism	Updated Tramadol Drug Safety Communication (9/21/15) Consumer Update: Codeine and Tramadol can Cause Breathing Problems for Children (4/20/2017)  FDA Statement (4/21/2017)  The Boxed Warning, Contraindications, Warnings and Precautions, Use in Specific Populations, Patient Counseling Information, and Medication Guide sections of the tramadol labeling were updated in August 2017 to reflect the risks of respiratory depression and CYP2D6 ultra-rapid metabolism. Tramadol label
Tumor Necrosis Factor (TNF) blockers: Cimzia (certolizumab pegol) injection Enbrel (etanercept) injection Humira (adalimumab) injection Remicade (infliximab) solution Simponi & Simponi Aria (golimumab) injection	Psychiatric and nervous system disorders	FDA is evaluating the need for regulatory action.
Zerbaxa (ceftolozane and tazobactam) injection	Drug dosing issues	The “Drug and Administration” section of the labeling and the vial and carton labeling were updated regarding the drug strength. Zerbaxa Labeling Zerbaxa Drug Safety Communication (5/20/15)