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  5. FDA's Adverse Event Reporting System (FAERS)
  6. April - June 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. FDA's Adverse Event Reporting System (FAERS)

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 August 26, 2024)

Acetadote (acetylcysteine)

Generic products containing acetylcysteine

Overdose

FDA is evaluating the need for regulatory action.

Aromatase inhibitors

  • Arimidex (anastrozole)
  • Aromasin (exemestane)
  • Femara (letrozole)

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

Updated

The “Information for Patients” section of the labeling was updated in June 2024 to include hypersensitivity and other serious reactions and expanded the list of symptoms warranting immediate medical attention.

Example: Bactrim labeling

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

  • Actonel (risedronate sodium)
  • Atelvia (risedronate sodium)
  • Binosto (alendronate sodium)
  • Boniva (ibandronate sodium)
  • Fosamax (alendronate sodium)
  • Fosamax Plus D (alendronate sodium/cholecalciferol)
  • Reclast (zoledronic acid)

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

  • Ajovy (fremanezumab-vfrm)
  • Aimovig (erenumab-aooe)
  • Emgality (galcanezumab-gnlm)
  • Nurtec ODT (rimegepant)
  • Qulipta (atogepant)
  • Ubrelvy (ubrogepant)
  • Vyepti (eptinezumab-jjmr)

Raynaud’s phenomenon

FDA is evaluating the need for regulatory action.

Cholinesterase inhibitors

  • Adlarity (donepezil transdermal system)
  • Aricept (donepezil hydrochloride)
  • Aricept ODT (donepezil hydrochloride)
  • Bloxiverz (neostigmine methylsulfate)
  • Enlon-Plus (edrophonium chloride and atropine sulfate)
  • Exelon Patch (rivastigmine)
  • Mestinon (pyridostigmine bromide)
  • Namzaric (memantine and donepezil hydrochlorides)
  • Neostigmine methylsulfate
  • Prevduo (neostigmine methylsulfate and glycopyrrolate)
  • Pyridostigmine bromide
  • Razadyne ER (galantamine)
  • Regonol (pyridostigmine bromide)
  • Tensilon (edrophonium chloride)

 

Electrocardiogram QT prolonged

FDA is evaluating the need for regulatory action.

Cholinesterase inhibitors

  • Adlarity (donepezil transdermal system)
  • Aricept (donepezil hydrochloride)
  • Aricept ODT (donepezil hydrochloride)
  • Bloxiverz (neostigmine methylsulfate)
  • Enlon-Plus (edrophonium chloride and atropine sulfate)
  • Exelon Patch (rivastigmine)
  • Mestinon (pyridostigmine bromide)
  • Namzaric (memantine and donepezil hydrochlorides)
  • Neostigmine methylsulfate
  • Prevduo (neostigmine methylsulfate and glycopyrrolate)
  • Pyridostigmine bromide
  • Razadyne ER (galantamine)
  • Regonol (pyridostigmine bromide)
  • Tensilon (edrophonium chloride)

 

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

  • Brineura (cerliponase alfa)
  • Cerezyme (imiglucerase)
  • Elelyso (taliglucerase alfa)
  • Fabrazyme (agalsidase beta)
  • Kanuma (sebelipase alfa)
  • Naglazyme (galsulfase)
  • Strensiq (asfotase alfa)
  • Vpriv (velaglucerase alfa)

 

Hypersensitivity

FDA is evaluating the need for regulatory action.

Gadolinium-based contrast agents

  • Dotarem (gadoterate meglumine)
  • Elucirem (gadopiclenol)
  • Eovist (gadoxetate disodium)
  • Gadavist (gadobutrol)
  • MultiHance (gadobenate dimeglumine)
  • MultiHance Multipack (gadobenate dimeglumine)
  • Omniscan (gadodiamide) Pharmacy Bulk Package
  • Omniscan (gadodiamide)
  • Prohance (gadoteridol injection)
  • Prohance Multipack (gadoteridol injection)

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

  • Altoprev (lovastatin extended-release)
  • Atorvaliq (atorvastatin calcium)
  • Caduet (amlodipine and atorvastatin)
  • Crestor (rosuvastatin)
  • Ezallor Sprinkle (rosuvastatin)
  • Flolipid (simvastatin)
  • Lescol XL (fluvastatin sodium)
  • Liptruzet (ezetimibe and atorvastatin)
  • Livalo (pitavastatin)
  • Nikita (pitavastatin)
  • Pravachol (pravastatin sodium)
  • Roszet (rosuvastatin and ezetimibe)
  • Vytorin (ezetimibe and simvastatin)
  • Zypitamag (pitavastatin)

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.

Mounjaro Labeling

 

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.

 

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