January - March 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
| Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of June 22, 2022) |
|---|---|---|
|
Addyi (flibanserin) |
Accidental exposure to product by child |
FDA is evaluating the need for regulatory action. |
|
Betadine (povidone-iodine) E-Z Prep (povidone-iodine) E-Z Prep 220 (povidone-iodine)
|
Intentional product misuse |
FDA decided that no action is necessary at this time based on available information. |
|
Buphenyl (sodium phenylbutyrate) Generic products containing sodium phenylbutyrate |
Accidental overdose |
FDA is evaluating the need for regulatory action. |
|
Farxiga (dapagliflozin) Glyxambi (empagliflozin; linagliptin) Invokamet (canagliflozin; metformin hydrochloride) Invokamet XR (canagliflozin; metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Lithobid (lithium carbonate) Lithium Carbonate Lithium Citrate Qtern (dapagliflozin; saxagliptin hydrochloride) Qtern XR (dapagliflozin; saxagliptin hydrochloride) Segluromet (ertugliflozin; metformin hydrochloride) Steglatro (ertugliflozin) Steglujan (ertugliflozin; sitagliptin phosphate) Synjardy (empagliflozin; metformin hydrochloride) Synjardy XR (empagliflozin; metformin hydrochloride) Trijardy XR (empagliflozin; linagliptin; metformin hydrochloride) Xigduo XR (dapagliflozin; metformin hydrochloride Generic products containing SGLT2 inhibitors and lithium carbonate or lithium citrate |
Sodium-glucose co-transporter 2 (SGLT2) inhibitor and lithium drug interaction |
FDA is evaluating the need for regulatory action. |
|
HMG-CoA reductase inhibitors
Generic products containing HMG-CoA reductase inhibitors |
Drug reaction with eosinophilia and systemic symptoms |
FDA is evaluating the need for regulatory action. |
|
HMG-CoA reductase inhibitors
Generic products containing HMG-CoA reductase inhibitors |
Lichen planus |
FDA is evaluating the need for regulatory action. |
|
HMG-CoA reductase inhibitors
Generic products containing HMG-CoA reductase inhibitors |
Immune-mediated myositis |
FDA is evaluating the need for regulatory action. |
|
Kalydeco (ivacaftor) Orkambi (lumacaftor/ivacaftor) Symdeko (tezacaftor/ivacaftor) Trikafta (elexacaftor; tezacaftor; and ivacaftor)
|
Anaphylactic reaction |
FDA is evaluating the need for regulatory action. |
|
Ocrevus (ocrelizumab) |
Progressive multifocal leukoencephalopathy |
FDA is evaluating the need for regulatory action. |
|
Octagam 10% [Immune Globulin Intravenous (Human)] |
Increased hypersensitivity reactions in patients receiving certain product lots |
FDA is evaluating the need for regulatory action. |
|
Reblozyl (luspatercept-aamt) |
Extramedullary hematopoietic (EMH) masses |
FDA is evaluating the need for regulatory action.
|
|
Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake (SNRI) inhibitors
Generic products containing selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors |
Anosmia |
FDA is evaluating the need for regulatory action. |
|
Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake (SNRI) inhibitors
Generic products containing selective serotonin reuptake inhibitors and serotonin and norepinephrine reuptake inhibitors |
Hyposmia |
FDA is evaluating the need for regulatory action. |