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  4. Surveillance: Post Drug-Approval Activities
  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. August 5, 2022 Posting | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

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

2018

2019

2020


April – June 2018

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional 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/effect

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

Jevtana (cabazitaxel)

Therapeutic product cross-reactivity

FDA 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)

Tuberculosis

FDA 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 Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of July 20, 2022)

Activase (alteplase)

Cathflo Activase (alteplase)

Product name confusion

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

Max Strength Anal Desensitizing Lub containing 5% lidocaine

Product administered to patient of inappropriate age

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

 

 

January – March 2019

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional 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 Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of July 20, 2022)

Kuvan (sapropterin dihydrochloride)

Gastric ulcer

The “Warnings and Precautions,” “Adverse Reactions,” “Patient Counseling Information,” and “Patient Information” sections of the Kuvan labeling were updated December 2019 to include esophagitis and expanded gastritis to upper gastrointestinal mucosal inflammation.          

Kuvan labeling 

Livalo (pitavastatin calcium)

Nikita (pitavastatin sodium)

Zypitamag (pitavastatin magnesium)

Generic products containing pitavastatin

Angioedema

The “Contraindications” and “Adverse Reactions” sections of the pitavastatin labeling were updated October 2019 to February 2020 to include angioedema.                                

Livalo labeling

Nikita labeling

Zypitamag labeling  

 

 

July – September 2019

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of July 20, 2022)

Lenvima (lenvatinib mesylate)

Interstitial lung disease

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

Ferrlecit (ferric oxyhydroxide)

Shock

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

 

 

October – December 2019

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of July 20, 2022)

Black salve

Products containing sanguinarine, Sanguinaria canadensis, bloodroot, and zinc chloride

Soft tissue necrosis

FDA Consumer Update: Drugs - Do Not Use: Black Salve is Dangerous and Called by Many Names, October 13, 2020

        

Cesium chloride (compounded drug)

Electrocardiogram QT prolongation

Human Drug Compounding Risk Alert: FDA alerts health care professionals of significant safety risks associated with cesium chloride, August 20, 2018

 

FDA Response to a Citizen Petition, Docket No. FDA-2017-P-6758, July 23, 2018

Conzip (tramadol hydrochloride)

Qdolo (tramadol hydrochloride)

Ultram (tramadol hydrochloride)

Ultracet (tramadol hydrochloride; acetaminophen)

Generic products containing tramadol hydrochloride

Hypoglycemia

The “Warnings and Precautions” section of the tramadol product labeling was updated September 2021 to include hypoglycemia.                                      

Example: Ultram labeling

 

Doptelet (avatrombopag maleate)

Hypersensitivity

The “Adverse Reactions” section of Doptelet labeling was updated August 2020 to include hypersensitivity.

Doptelet labeling

Fluoroquinolones

  • Avelox (moxifloxacin hydrochloride)
  • Baxdela (delafloxacin )
  • Cipro (ciprofloxacin hydrochloride)
  • Cipro XR (ciprofloxacin)
  • Factive (gemifloxacin mesylate)
  • Moxifloxacin

Generic products containing fluoroquinolones

Artery dissection

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

Ninlaro (ixazomib citrate)

Cardiac failure acute

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

Sodium chlorite

Vomiting

FDA News Release warns consumers about the dangerous and potentially life threatening side effects of Miracle Mineral Solution, August 12, 2019

FDA Consumer Update - Danger: Don’t drink Miracle Mineral Solution or similar products, August 12, 2019

FDA News Release warns seller marketing dangerous chlorine dioxide products that claim to treat or prevent COVID-19, April 8, 2020               

 

 

January – March 2020

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of July 20, 2022)

Moxifloxacin, for intraocular use (compounded drug)

Toxic anterior segment syndrome

FDA Compounding Risk Alert: FDA alerts health care professionals of risks associated with intraocular use of compounded moxifloxacin, August 12, 2020

Propylhexedrine

Drug abuse and dependence

FDA published a Drug Safety Communication in March 2021 to convey the risks associated with abuse and misuse of the nasal decongestant propylhexedrine

Rubraca (rucaparib camsylate)

Hypersensitivity

The “Adverse Reactions” section of the Rubraca labeling was updated May 2020 to include hypersensitivity.     

Rubraca labeling                   

 

 

 
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