January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions.
Glucagon-like peptide-1 (GLP-1) analogues
- Adlyxin (lixisenatide)
- Bydureon (exenatide)
- Bydureon BCise (exenatide)
- Byetta (exenatide)
- Ozempic (semaglutide)
- Rybelsus (semaglutide)
- Saxenda (liraglutide)
- Soliqua (insulin glargine and lixisenatide)
- Trulicity (dulaglutide)
- Victoza (liraglutide)
- Xultophy (insulin degludec and liraglutide)
The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes.
Example: Trulicity labeling
FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information.
FDA determined that no action is necessary at the time based on available information.
A FDA Drug Safety Communication was issued on June 16, 2021.
Amlodipine and Levamlodipine Products
- Azor (amlodipine and olmesartan medoxomil)
- Caduet (amlodipine besylate and atorvastatin calcium)
- Conjupri (levamlodipine maleate)
- Consensi (amlodipine besylate and celecoxib)
- Exforge (amlodipine and valsartan)
- Exforge HCT (amlodipine/valsartan and hydrochlorothiazide)
- Lotrel (amlodipine besylate and benazepril hydrochloride)
- Katerzia (amlodipine benzoate)
- Norvasc (amlodipine besylate)
- Prestalia (amlodipine besylate and perindopril arginine)
- Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide)
- Twynsta (amlodipine and telmisartan)
FDA determined that no action is necessary at the time based on available information.
Betaseron (interferon beta-1b)
Extavia (interferon beta-1b)
Plegridy (pegylated interferon beta-1a)
Rebif (interferon beta-1a)
Imfinzi (durvalumab)
Keytruda (pembrolizumab)
Libtayo (cemiplimab-rwlc)
Opdivo (nivolumab)
Tecentriq (atezolizumab)
FDA determined that no action is necessary at the time based on available information.
Imfinzi (durvalumab)
Keytruda (pembrolizumab)
Libtayo (cemiplimab-rwlc)
Opdivo (nivolumab)
Tecentriq (atezolizumab)
The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis.
Example: Keytruda labeling
FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information.
Chloroquine
Generic products containing chloroquine
The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis.
Pradaxa (dabigatran etexilate mesylate)
Savaysa (edoxaban tosylate)
Xarelto (ribaroxaban)
Generic products containing dabigatran etexilate mesylate
Generic products containing ribaroxaban
Eliquis label
Pradaxa label
Savaysa label
Xarelto label
Depakote ER (divalproex sodium)
Stavzor (valproic acid)
Generic products containing divalproex sodium
Generic products containing valproic acid
The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis.
Example: Depakote labeling
The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis.
The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations.
Kisqali (ribociclib)
Kisqali Femara Co-Pack (letrozole and ribociclib)
Verzenio (abemaciclib)
FDA determined that no action is necessary at the time based on available information.
FDA determined that no action is necessary at the time based on available information.
The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis.
The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis.
The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration.
FDA determined that no action is necessary at the time based on available information.
The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered.
Trulance Label
Trulance Label
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