Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between April – June 2015

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of January 13, 2016)



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)disclaimer icon

Brintellix (vortioxetine) tablet

Brilinta (ticagrelor) tablet

Brand name confusion

FDA is evaluating the need for regulatory action

Brintellix & Brilinta Drug Safety Communication (7/30/15)

Calcium carbonate

Milk-alkali syndrome (hypercalcemia)

FDA is evaluating the need for regulatory action.

Daliresp (roflumilast) tablet


“Postmarketing Experience” section updated to include gynecomastia.

Daliresp Labelingdisclaimer icon

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

FDA is evaluating the need for regulatory action.

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


FDA is evaluating the need for regulatory action.

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

FDA continues to evaluate the need for regulatory action.

Tramadol Drug Safety Communication (9/21/15)

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)





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