August 5, 2022 Posting | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

2018 April - June 2018 July - September 2018 2019 January - March 2019 April - June 2019 July - September 2019 October - December 2019 2020 January - March 2020 April – June 2018 Product Name: Trade (Active Ingredient) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information (as of July 20, 2022) Bavencio (avelumab) Imfinzi (durvalumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Cardiac failure FDA decided that no action is necessary at this time based on available information. Invega Sustenna (paliperidone palmitate) Invega Trinza (paliperidone palmitate) Lack of efficacy/effectFDA decided that no action is necessary at this time based on available information.Jevtana (cabazitaxel)Therapeutic product cross-reactivityFDA decided that no action is necessary at this time based on available information. Nexavar (sorafenib tosylate) Generic products containing sorafenib Cardiac failure The “Warnings and Precautions” section of the Nexavar labeling was updated December 2018 to include congestive heart failure. Example: Nexavar labeling PD-1 Blocking Antibody (Drug class) Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Cytokine release syndrome The “Warnings and Precautions” section of the PD-1 blocking antibody labeling was updated to include systemic inflammatory response syndrome. Example: Tecentriq labeling PD-1 Blocking Antibody (Drug Class) Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) TuberculosisFDA decided that no action is necessary at this time based on available information.Perjeta (pertuzumab)Angioedema The “Warnings and Precautions” section of the Perjeta labeling was updated September 2018 to include angioedema. Perjeta labeling Tecentriq (atezolizumab) Immune-mediated nephritis The “Warnings and Precautions” section of the Tecentriq labeling was updated November 2020 to include immune-mediated nephritis with renal dysfunction. Tecentriq labeling Tecentriq (atezolizumab)Stevens-Johnson syndrome The “Warnings and Precautions” section of the Tecentriq labeling was updated April 2018 to include Stevens Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN). Tecentriq labeling Xalkori (crizotinib)Blood creatine phosphokinase increase The “Adverse Reactions” section of the Xalkori labeling was updated June 2019 to include increased blood creatine phosphokinase. Xalkori labeling July – September 2018 Product Name: Trade (Active Ingredient) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information (as of July 20, 2022) Activase (alteplase) Cathflo Activase (alteplase) Product name confusionFDA decided that no action is necessary at this time based on available information.Max Strength Anal Desensitizing Lub containing 5% lidocaineProduct administered to patient of inappropriate ageFDA decided that no action is necessary at this time based on available information. January – March 2019 Product Name: Trade (Active Ingredient) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information (as of July 20, 2022)Certain atorvastatin product (generic product for the trade name Lipitor)Product Quality Issue FDA decided that no action is necessary at this time based on available information. FDA Statement: FDA’s continuing efforts to maintain its strong oversight of generic drug quality issues domestically and abroad (2/22/2019) Injectafer (ferric carboxymaltose)Osteomalacia The “Warnings and Precautions” section of the Injectafer labeling was updated February 2020 to include symptomatic hypophosphatemia. Injectafer labeling April – June 2019 Product Name: Trade (Active Ingredient) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information (as of July 20, 2022) July – September 2019 Product Name: Trade (Active Ingredient) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information (as of July 20, 2022)Lenvima (lenvatinib mesylate)Interstitial lung diseaseFDA decided that no action is necessary at this time based on available information.Ferrlecit (ferric oxyhydroxide)ShockFDA decided that no action is necessary at this time based on available information. October – December 2019 Product Name: Trade (Active Ingredient) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information (as of July 20, 2022) January – March 2020 Product Name: Trade (Active Ingredient) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information (as of July 20, 2022)