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  6. January - March 2024 | 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)

January - March 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this publication.
Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of June 21, 2024)

Akeega (niraparib and abiraterone acetate)

Zejula (niraparib)

Haemorrhage

FDA is evaluating the need for regulatory action.

Certain amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate (generic product)

 

Lack of efficacy/effect

FDA is evaluating the need for regulatory action.

Calcitonin gene-related peptide (CGRP) inhibitors

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

 

Hypertension

FDA is evaluating the need for regulatory action.

Certain ertapenem injection (generic product)

Certain meropenem injection (generic product)

Wrong drug errors related to look alike labeling

The color scheme for ertapenem container labels and carton labeling was revised in June 2024 to help differentiate the products.

 

Cotellic (cobimetinib)

Colitis

FDA is evaluating the need for regulatory action.

Doxycycline containing products

  • Acticlate (doxycycline hyclate)
  • Acticlate Cap (doxycycline hyclate)
  • Atridox (doxycycline hyclate)
  • Doryx (doxycycline hyclate)
  • Lymepak (doxycycline hyclate)
  • Monodox (doxycycline)
  • Oracea (doxycycline)
  • Periostat (doxycycline hyclate)
  • Vibramycin (doxycycline hyclate)
  • Vibramycin (doxycycline calcium)
  • Vibra-tabs (doxycycline hyclate)

Psychiatric disorders

FDA is evaluating the need for regulatory action.

ELEVIDYS (delandistrogene moxeparvovec-rokl)

Hypersensitivity including anaphylaxis

 

The “Warnings and Precautions,” “Postmarketing Experience,” and “Patient Counseling Information” sections of the labeling for Elevidys were updated in June 2024 to include Infusion-related Reactions.

Package Insert - ELEVIDYS

Gabapentinoids

  • Gralise (gabapentin)
  • Horizant (gabapentin enacarbil)
  • Lyrica (pregabalin)
  • Lyrica CR (pregabalin)
  • Neurontin (gabapentin)

Withdrawal syndrome

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)
  • Omniscan (gadodiamide) Pharmacy Bulk Package
  • Prohance (gadoteridol injection)
  • Prohance Multipack (gadoteridol injection)

Acute respiratory distress syndrome

FDA is evaluating the need for regulatory action.

Glucagon-like peptide-1 (GLP-1) receptor agonists

  • Adlyxin (lixisenatide)
  • Bydureon (exenatide)
  • Bydureon BCise (exenatide)
  • Byetta (exenatide)
  • Mounjaro (tirzepatide)
  • Ozempic (semaglutide)
  • Rybelsus (semaglutide)
  • Victoza (liraglutide)
  • Saxenda (liraglutide)
  • Soliqua (insulin glargine and lixisenatide)
  • Trulicity (dulaglutide)
  • Wegovy (semaglutide)
  • Xultophy (insulin degludec and liraglutide)
  • Zepbound (tirzepatide)

Dysaesthesia

FDA is evaluating the need for regulatory action.

Gocovri (amantadine)

Osmolex ER (amantadine)

 

Corneal oedema

FDA is evaluating the need for regulatory action.

Gonadotropin-releasing hormone (GnRH) agonists

  • Camcevi (leuprolide mesylate)
  • Eligard (leuprolide acetate)
  • Lupron (leuprolide acetate)
  • Lutrate Depot (leuprolide acetate)
  • Trelstar (triptorelin pamoate)
  • Zoladex (goserelin implant)

 

Severe cutaneous adverse reactions

FDA is evaluating the need for regulatory action.

Human growth hormone products

  • Humatrope (somatropin)
  • Ngenla (somatrogon-ghla)
  • Nutropin AQ (somatropin)
  • Omnitrope (somatropin)
  • Saizen (somatropin)
  • Skytrofa (lonapegsomatropin-tcgd)
  • Sogroya (somapacitan-beco)
  • Zomacton (somatropin)

 

Osteonecrosis

FDA is evaluating the need for regulatory action.

Humatrope (somatropin)

Wrong dose errors related to pen and cartridge mismatch

FDA is evaluating the need for regulatory action.

Intravenous lipid emulsions (IVLEs)

  • Clinolipid (lipid injectable emulsion)
  • Intralipid 10% (lipid injectable emulsion)
  • Intralipid 20% (lipid injectable emulsion)
  • Intralipid 30% (lipid injectable emulsion)
  • Kabiven (amino acids, electrolytes, dextrose, and lipid injectable emulsion)
  • Nutrilipid 20% (lipid injectable emulsion)
  • Omegaven (fish oil triglycerides) injectable emulsion
  • Perikabiven (amino acids, electrolytes, dextrose, and lipid injectable emulsion)
  • SMOFlipid (lipid injectable emulsion)

 

Anaphylactic reaction

FDA is evaluating the need for regulatory action.

Kalydeco (ivacaftor)

Orkambi (lumacaftor and ivacaftor)

Symdeko (tezacaftor and ivacaftor)

Trikafta (elexacaftor, tezacaftor, and ivacaftor)

 

Psychiatric disorders

FDA is evaluating the need for regulatory action.

Krazati (adagrasib)

Toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

Lemtrada (alemtuzumab)

 

Colitis

The “Warnings and Precautions” section of the labeling was updated in May 2024 to include the risk of immune-mediated colitis.

Lemtrada labeling

 

Leqvio (inclisiran)

Hypersensitivity

The “Contraindications” and “Adverse Reactions” sections of the labeling were updated in June 2024 to include the risk of hypersensitivity. 

Leqvio labeling

 

Lybalvi (olanzapine and samidorphan)

Drug-drug interaction

FDA is evaluating the need for regulatory action.

Mavenclad (cladribine)

 

Drug-induced liver injury

FDA is evaluating the need for regulatory action.

Norepinephrine reuptake inhibitors (NRIs)

  • Qelbree (viloxazine)
  • Strattera (atomoxetine hydrochloride)

 

Withdrawal syndrome

FDA is evaluating the need for regulatory action.

Certain prasugrel (generic product)

Certain pimavanserin tartrate (generic product)

Wrong drug errors related to product dosage form identification

The code imprint for prasugrel was revised in March 2024 to help differentiate the dosage forms.

 

Sphingosine 1-phosphate (S1P) receptor modulators

  • Gilenya (fingolimod)
  • Mayzent (siponimod)
  • Ponvory (ponesimod)
  • Tascenso ODT (fingolimod)
  • Zeposia (ozanimod)

 

Macular oedema

The “Warnings and Precautions” section of the labeling was updated in June 2024 to include the risk of macular edema.

Example: Gilenya labeling

 

Sphingosine 1-phosphate (S1P) receptor modulators

  • Gilenya (fingolimod)
  • Mayzent (siponimod)
  • Ponvory (ponesimod)
  • Tascenso ODT (fingolimod)
  • Zeposia (ozanimod)

Skin cancer

The “Warnings and Precautions” section of the labeling was updated in June 2024 to include the risk of cutaneous malignancy.

Example: Gilenya labeling

Technetium diphosphonates

  • CIS-PYRO (Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection)
  • CIS-MDP (Kit for the Preparation of Technetium Tc 99m Medronate Injection)
  • MDP-Bracco (Kit for the Preparation of Technetium Tc 99m Medronate)
  • Phosphotec (Kit for the Preparation of Technetium Tc 99m Pyrophosphate)
  • Technescan HDP (Kit for the Preparation of Technetium Tc 99m Oxidronate)
  • Technescan PYP (Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection)
  • MDP Multidose Kit and Multidose Utilipak (Kit for the Preparation of Technetium Tc99m Medronate Injection)
  • DRAXIMAGE MDP-25 (Kit for the Preparation of Technetium Tc 99m Medronate Injection)
  • Osteolite (Technetium Tc 99m Medronate)

 

Drug interaction

FDA is evaluating the need for regulatory action.

Tecvayli (teclistamab-cqyv)

Tumour lysis syndrome

FDA is evaluating the need for regulatory action.

Tetracyclines

Fixed drug eruption

FDA is evaluating the need for regulatory action.

Transderm Scop (scopolamine transdermal system)

Hyperthermia

FDA is evaluating the need for regulatory action.

Zelboraf (vemurafenib)

Colitis

FDA is evaluating the need for regulatory action.

 
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