April - June 2023 | 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 September 13, 2023) |
---|---|---|
Acetadote (acetylcysteine) Generic products containing acetylcysteine |
Overdose |
FDA is evaluating the need for regulatory action. |
Aromatase inhibitors
Generic products containing aromatase inhibitors |
Tendon disorders |
FDA is evaluating the need for regulatory action. |
Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (peginterferon beta-1a) Rebif (interferon beta-1a) |
Myocardial infarction |
FDA decided no action is necessary at this time based on available information. |
Bactrim (sulfamethoxazole and trimethoprim) Septra (trimethoprim and sulfamethoxazole) Sulfatrim (sulfamethoxazole and trimethoprim) Generic products containing sulfamethoxazole and trimethoprim
|
Acute respiratory failure |
FDA is evaluating the need for regulatory action. |
Bafiertam (monomethyl fumarate) Tecfidera (dimethyl fumarate) Vumerity (diroximel fumarate) Generic products containing dimethyl fumarate, diroximel fumarate or monomethyl fumarate |
Gastrointestinal haemorrhage |
FDA is evaluating the need for regulatory action. |
Bisphosphonates
Generic products containing bisphosphonates |
Non-femoral atypical fracture |
FDA is evaluating the need for regulatory action. |
Brilinta (ticagrelor) Crestor (rosuvastatin) Ezallor Sprinkle (rosuvastatin) Roszet (rosuvastatin and ezetimibe) |
Rhabdomyolysis |
FDA is evaluating the need for regulatory action. |
Bylvay (odevixibat) Livmarli (maralixibat)
|
Haemorrhage |
FDA is evaluating the need for regulatory action. |
Calcitonin gene-related peptide receptor antagonists
|
Raynaud’s phenomenon |
FDA is evaluating the need for regulatory action. |
Cholinesterase inhibitors
|
Electrocardiogram QT prolonged |
FDA is evaluating the need for regulatory action. |
Cholinesterase inhibitors
|
Torsade de pointes |
FDA is evaluating the need for regulatory action. |
Efudex (fluorouracil)
|
Look alike container labels that contribute to wrong drug errors |
FDA is evaluating the need for regulatory action. |
Certain fluorouracil product (generic product for the trade name Efudex) |
||
Enzyme replacement therapy
|
Hypersensitivity |
FDA is evaluating the need for regulatory action. |
Gadolinium-based contrast agents
|
Pancreatitis acute |
FDA is evaluating the need for regulatory action. |
Galzin (zinc acetate) Zinc Chloride Injection Generic products containing zinc chloride |
Cytopenia |
FDA is evaluating the need for regulatory action. |
Givlaari (givosiran) |
Hyperhomocysteinaemia |
FDA is evaluating the need for regulatory action. |
Givlaari (givosiran) |
Pancreatitis |
FDA is evaluating the need for regulatory action. |
HMG-CoA reductase inhibitors
Generic products containing HMG-CoA reductase inhibitors |
Myasthenia gravis |
FDA is evaluating the need for regulatory action. |
Isoniazid Nydrazid (isoniazid) Rifater (rifampin, isoniazid, and pyrazinamide) Generic products containing isoniazid |
Severe cutaneous adverse reactions |
FDA is evaluating the need for regulatory action. |
Kalydeco (ivacaftor) Orkambi (lumacaftor and ivacaftor) Symdeko (tezacaftor/ivacaftor) Trikafta (elexacaftor, tezacaftor, and ivacaftor)
|
Cataract congenital |
FDA is evaluating the need for regulatory action. |
Certain loratadine product (generic product for the trade name Claritin) Certain acetaminophen and oxycodone product (generic product) |
Similar tablet appearance that may contribute to wrong drug errors |
FDA is evaluating the need for regulatory action. |
Midazolam in Sodium Chloride Injection Certain Magnesium Sulfate in Dextrose Injection (generic product) |
Look alike container labels that contribute to wrong drug errors |
FDA is evaluating the need for regulatory action. |
Mounjaro (tirzepatide) |
Hypersensitivity |
The “Contraindications”, “Warnings and Precautions”, and “Postmarketing Experience” sections of the labeling were updated July 2023 to include serious hypersensitivity reactions, including anaphylaxis and angioedema.
|
Padcev (enfortumab vedotin-ejfv) |
Allergic conditions |
FDA is evaluating the need for regulatory action. |
Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) |
Accidental ingestion of product desiccant
|
FDA is evaluating the need for regulatory action. |
Tabrecta (capmatinib) |
Thrombocytopenia |
FDA is evaluating the need for regulatory action. |
Tafinlar (dabrafenib) |
Radiation recall phenomenon |
FDA is evaluating the need for regulatory action. |
Tivdak (tisotumab vedotin-tftv) |
Allergic conditions |
FDA is evaluating the need for regulatory action. |
Vyvgart (efgartigimod alfa-fcab) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) |
Anaphylactic reaction |
FDA is evaluating the need for regulatory action. |
Vyvgart (efgartigimod alfa-fcab) Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) |
Infusion related reaction |
FDA is evaluating the need for regulatory action. |