August 5, 2022 Posting | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Bavencio (avelumab)
Imfinzi (durvalumab)
Tecentriq (atezolizumab)
Yervoy (ipilimumab)
FDA decided that no action is necessary at this time based on available information.
Invega Sustenna (paliperidone palmitate)
Invega Trinza (paliperidone palmitate)
Nexavar (sorafenib tosylate)
Generic products containing sorafenib
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)
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)
The “Warnings and Precautions” section of the Perjeta labeling was updated September 2018 to include angioedema.
Tecentriq (atezolizumab)
The “Warnings and Precautions” section of the Tecentriq labeling was updated November 2020 to include immune-mediated nephritis with renal dysfunction.
The “Warnings and Precautions” section of the Tecentriq labeling was updated April 2018 to include Stevens Johnson Syndrome (SJS)/toxic epidermal necrolysis (TEN).
The “Adverse Reactions” section of the Xalkori labeling was updated June 2019 to include increased blood creatine phosphokinase.
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