August 5, 2022 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)
[Formerly FDA Adverse Event Reporting System (FAERS)]
FDA Adverse Event Monitoring System (AEMS)
FDA is implementing the Adverse Event Monitoring System (AEMS) to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines.
This unified platform is designed to enhance data quality and consistency through standardized reporting protocols, streamline reporting processes to reduce administrative burden on both internal FDA staff and external stakeholders, and strengthen safety surveillance capabilities through advanced case processing workflows, AI-based redaction and digitization tools, enhanced analytics, and comprehensive cross-product surveillance.
Beyond adverse event reporting, AEMS will serve as a centralized platform for managing consumer complaints, regulatory misconduct reports, and whistleblower submissions across all FDA centers. This comprehensive approach will enable more effective safety monitoring, facilitate trend identification across diverse product categories, and support timely regulatory decision-making to protect public health through improved data integration and analysis capabilities.
2020
2019
2018
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. |
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 |
|
| 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. |
Fluoroquinolones
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 |
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. |
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. |
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. |
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. |
| Injectafer (ferric carboxymaltose) | Osteomalacia | The “Warnings and Precautions” section of the Injectafer labeling was updated February 2020 to include symptomatic hypophosphatemia. |
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. |
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)
(pembrolizumab)
(atezolizumab)
| 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)
(pembrolizumab)
(atezolizumab)
| 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.
|
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 (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). |
| Xalkori (crizotinib) | Blood creatine phosphokinase increase | The “Adverse Reactions” section of the Xalkori labeling was updated June 2019 to include increased blood creatine phosphokinase. |