July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Ajovy (fremanezumab-vfrm)
Emgality (galcanezumab-gnlm)
Nurtec ODT (rimegepant)
Ubrelvy (ubrogepant)
Vyepti (eptinezumab-jjmr)
The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension.
Example: Ajovy labeling
Apriso (mesalamine)
Asacol (mesalamine)
Asacol HD (mesalamine)
Azulfidine (sulfasalazine)
Azulfidine EN-Tabs (sulfasalazine)
Canasa (mesalamine)
Colazal (balsalazide disodium)
Delzicol (mesalamine)
Dipentum (osalazine sodium)
Giazo (balsalazide disodium)
Lialda (mesalamine)
Rowasa (mesalamine)
Pentasa (mesalamine)
The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions.
Example: Delzicol labeling
Avastin (bevacizumab)
Mvasi (bevacizumab-awwb)
Zirabev (bevacizumab-bvzr)
FDA determined that no action is necessary at the time based on available information.
Avastin (bevacizumab)
Mvasi (bevacizumab-awwb)
Zirabev (bevacizumab-bvzr)
The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions.
Example: Avastin labeling
Ayvakit (avapritinib)
The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity.
Azacitidine
Onureg (azacitidine)
Vidaza (azacitidine)
Generic products containing azacitidine
The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis.
Example: Vidaza labeling
FDA determined that no action is necessary at the time based on available information for Onureg.
Bavencio (avelumab)
Imfinzi (durvalumab)
Libtayo (cemiplimab-rwlc)
Keytruda (pembrolizumab)
Opdivo (nivolumab)
Tecentriq (atezolizumab)
Yervoy (ipilimumab)
FDA determined that no action is necessary at the time based on available information.
Cymbalta (duloxetine hydrochloride)
Drizalma Sprinkle (duloxetine hydrochloride)
Generic products containing duloxetine hydrochloride
This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately.
Darzalex (daratumumab)
Darzalex Faspro (daratumumab and hyaluronidase-fihj)
FDA determined that no action is necessary at the time based on available information.
Dipeptidyl peptidase-4 (DPP-4) inhibitors
- Glyxambi (empagliflozin and linagliptin)
- Janumet (metformin hydrochloride and sitagliptin phosphate)
- Janumet XR (metformin hydrochloride and sitagliptin phosphate)
- Jentadueto (linagliptin and metformin hydrochloride)
- Jentadueto XR (linagliptin and metformin hydrochloride)
- Kazano (alogliptin and metformin hydrochloride)
- Kombiglyze XR (metformin hydrochloride and saxagliptin)
- Nesina (alogliptin)
- Onglyza (saxagliptin)
- Oseni (alogliptin and pioglitazone)
- Steglujan (ertugliflozin and sitagliptin)
- Tradjenta (linagliptin)
- Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride)
- Qtern (saxagliptin and dapagliflozin)
Generic products containing dipeptidyl peptidase-4 inhibitors
The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis.
Example: Janumet labeling
FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information.
*An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted.
The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema.
Glucagon-like peptide-1 (GLP-1) analogues
- Adlyxin (lixisenatide)
- Bydureon (exenatide)
- Bydureon BCise (exenatide)
- Byetta (exenatide)
- Ozempic (semaglutide)
- Rybelsus (semaglutide)
- Saxenda (liraglutide)
- Soliqua 100/33 (insulin glargine and lixisenatide injection)
- Trulicity (dulaglutide)
- Victoza (liraglutide)
- Wegovy (semaglutide)
- Xultophy 100/3.6 (insulin degludec and liraglutide injection)
Generic products containing glucagon-like peptide-1 analogues
The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease.
Example: Adlyxin labeling
FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time.
Gonadotropin releasing hormone (GnRH) analogues
- Fensolvi (leuprolide acetate)
- Lupron Depot-PED (leuprolide acetate)
- Supprelin LA (histrelin acetate)
- Synarel (nafarelin acetate)
- Triptodur (triptorelin)
The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension.
Example: Fensolvi labeling
Jakafi (ruxolitinib phosphate)
Herpes simplex virus (HSV) reactivation and/or disseminated HSV
The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections.
Ibrance (palbociclib)
Kisqali (ribociclib)
Kisqali Femara Co-Pack (letrozole and ribociclib)
Embolic and thrombotic events, venous
The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism.
FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information.
FDA determined that no action is necessary at the time based on available information.
The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride.
The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing.
The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure.
The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention.
Sodium-glucose cotransporter-2 (SGLT-2) inhibitors
- Farxiga (dapagliflozin)
- Glyxambi (empagliflozin and linagliptin)
- Invokamet (canagliflozin and metformin hydrochloride)
- Invokamet XR (canagliflozin and metformin hydrochloride)
- Invokana (canagliflozin)
- Jardiance (empagliflozin)
- Qtern (saxagliptin and dapagliflozin)
- Steglatro (ertugliflozin)
- Steglujan (ertugliflozin and sitagliptin)
- Segluromet (ertugliflozin and metformin hydrochloride)
- Synjardy (empagliflozin and metformin hydrochloride)
- Synjardy XR (empagliflozin and metformin hydrochloride)
- Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride)
- Xigduo XR (dapagliflozin and metformin)
Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors
FDA determined that no action is necessary at the time based on available information.
Somatostatin Receptor Imaging Agents
- Detectnet (copper Cu-64 dotatate injection)
- Gallium Dotatoc (GA 68)
- Octreoscan (Indium In 111 Pentetreotide)
- Netspot (Gallium GA 68 Dotatate)
The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions.
Example: Netspot labeling
Stromectol (ivermectin)
Generic products containing ivermectin
FDA determined that no action is necessary at the time based on available information.
Stromectol (ivermectin)
Generic products containing ivermectin
The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity.
Example: Stromectol labeling
Sunosi (solriamfetol hydrochloride)
FDA determined that no action is necessary at the time based on available information.
The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration.
The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders.
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