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

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)

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

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

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 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

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)

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