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  6. October - December 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. FDA's Adverse Event Reporting System (FAERS)

October - December 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

 

Product Name: Trade (Active Ingredient) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of March 23, 2021)
AcetaminophenStevens-Johnson SyndromeFDA is evaluating the need for regulatory action.

Ajovy (fremanezumab-vfrm)

Vyepti (eptinezumab-jjmr)

Anaphylactic reaction

Updated

The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in September 2021 to include information about anaphylactic reactions.

Example: Ajovy labeling

Albuterol sulfate inhalerProduct quality issue due to device malfunctions/failure to dispense

Updated

FDA determined that no action is necessary at this time based on available information.

An FDA Alert was issued alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company at the retail level.

Alunbrig (brigatinib)

Xalkori (crizotinib)

Zykadia (ceritinib)

Photosensitivity reaction

Updated

The “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated between September 2021 and October 2021 to include information about photosensitivity.

Example: Alunbrig labeling

Ameluz (aminolevulinic acid hydrochloride)

Gleolan (aminolevulinic acid hydrochloride)

Levulan Kerastick (5-aminolevulinic acid hydrochloride)

Metvixia (methyl aminolevulinate hydrochloride)

Generic products containing aminolevulinic acid hydrochloride

HypersensitivityFDA is evaluating the need for regulatory action.

Benznidazole tablets

Fexinidazole tablets

Flagyl (metronidazole)

Flagyl ER (metronidazole)

Helidac Therapy (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride)

Metronidazole oral and intravenous

Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride)

Solosec (secnidazole)

Tindamax (tinidazole)

Generic products containing metronidazole (oral and intravenous)

Hepatic failure

Updated

The “Contraindications”, “Warnings”, and “Adverse Reactions” sections of the labeling were updated in December 2021 to include the risk of irreversible hepatotoxicity/acute liver failure in patients with Cockayne syndrome.

Example: Flagyl labeling

Carac (fluorouracil)

Efudex (fluorouracil)

Fluoroplex (fluorouracil)

Tolak (fluorouracil)

Product storage error

Updated

The container label, carton labeling, and “Patient Information” or “Patient Counseling Information” were revised between October 2021 and August 2022 to include proper storage to mitigate the potential for unintended exposures.

Example: Carac labeling

An FDA Consumer Update for Fluorouracil and Pet Safety was issued.

Definity (perflutren lipid microsphere)

Definity RT (perflutren lipid microsphere)

Lumason (sulfur hexafluoride lipid-type A microspheres)

Allergy to chemicals

FDA is evaluating the need for regulatory action.

 

Sodium-glucose cotransporter-2 (SGLT2) inhibitors

Farxiga (dapagliflozin)

Glyxambi (empagliflozin and linagliptin)

Invokana (canagliflozin)

Invokamet (canagliflozin and metformin hydrochloride)

Invokamet XR (canagliflozin and metformin hydrochloride)

Jardiance (empagliflozin)

Qtern (saxagliptin and dapagliflozin)

Qternmet XR (dapagliflozin, saxagliptin, and metformin hydrochloride)

Segluromet (ertugliflozin and metformin hydrochloride)

Steglatro (ertugliflozin)

Steglujan (ertugliflozin and sitagliptin)

Synjardy (empagliflozin and metformin hydrochloride)

Synjardy XR (empagliflozin and metformin hydrochloride)

Trijardy XR (empagliflozin, linagliptin, and metformin hydrochloride)

Xigduo XR (dapagliflozin and metformin)

Diabetic ketoacidosis in patients with Type 1 diabetes mellitus

Updated

FDA has determined that the last approved labeling is adequate, and that no further regulatory action is needed at this time.

GoLytely (polyethylene glycol 3350 and electrolytes)

MiraLAX (polyethylene glycol 3350)

MoviPrep (polyethylene glycol 3350, ascorbic acid, sodium ascorbate, sodium chloride, sodium sulfate, and potassium chloride)

NuLytely (polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate)

Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride)

Aspiration

Updated

The “Dosage and Administration”, “Warnings and Precautions”, and “Medication Guide” sections of the labeling were updated in May 2021 to include the risk of aspiration and to not mix with starch-based thickeners.

Example: GoLytely labeling

Nplate (romiplostim)Wrong dose

Updated

The container label, carton labeling, "Dosage and Administration" and "Description" sections of the labeling were revised in February 2022 to address confusion with the Nplate dosing and the amount of drug available in the vial with overfill.

Nplate labeling

Padcev (enfortumab vendotin-ejfv)Stevens-Johnson syndrome

Updated

The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in March 2021 to include severe cutaneous adverse reactions, including Stevens-Johnson syndrome.

Padcev labeling

Piqray (alpelisib)Colitis

Updated

The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in May 2022 to include colitis.

Pitocin (oxytocin)

Generic products containing oxytocin

Accidental overdose

Updated

The container label, carton labeling, and “How Supplied” sections of the labeling were updated in September 2022 to prevent labeling confusion among the marketed dosage strengths.

Example: Oxytocin labeling

Prolia (denosumab)

 

Hypersensitivity vasculitis

Updated

The “Adverse Reactions” section of the labeling was updated in May 2021 to include vasculitis.

Prolia labeling

Sarclisa (isatuximab-irfc)Anaphylactic reaction

Updated

The “Warnings and Precautions”, and “Patient Information” sections of the labeling were updated in March 2021 to include information about anaphylactic reactions.

Sarclisa labeling

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