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  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. April – June 2015 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

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 August 26, 2019)

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

FDA is evaluating the need for regulatory action.

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)