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Assessing the ARIA System's Ability to Evaluate a Safety Concern

 

The Food and Drug Administration (FDA) uses the Active Risk Identification and Analysis (ARIA) System to monitor the safety of medications. During the drug approval process, potential safety concerns are sometimes found that require further study after FDA approval. Before requiring the drug's manufacturer to conduct a post-approval safety study, FDA must determine whether it is feasible to answer the safety question in ARIA. FDA describes the reasons why a safety concern could or could not be evaluated in ARIA in the documents linked below.

ARIA Safety Concerns

Drug/Population Health Outcome(s) Approval Date Regulatory Link(s)
Kisunla (donanemab-azbt)
amyloid related imaging abnormality-edema (ARIA-E)
amyloid related imaging abnormality-hemosiderin deposition (ARIA-H)
intracerebral hemorrhage (ICH)
07/02/2024
Piasky (crovalimab-akkz)
adverse pregnancy and fetal outcomes
hypersensitivity reactions
infusion related reactions
injection site related reactions
serious infections
06/20/2024
Iqirvo (elafibranor)
adverse pregnancy and fetal outcomes
06/10/2024
Lumisight (pegulicianine) 04/17/2024
Voydeya (danicopan)
encapsulated bacterial infections
serious liver injury
03/30/2024
Winrevair (sotatercept)
adverse pregnancy and fetal outcomes
03/26/2024
Vafseo (vadadustat)
adverse pregnancy and fetal outcomes
heart failure
malignancy
serious gastrointestinal bleeding
venous thromboembolism
03/24/2024
Duvyzat (givinostat)
serious bleeding event
thrombocytopenia
03/21/2024
Tryvio (aprocitentan)
adverse pregnancy and fetal outcomes
03/19/2024
Rezdiffra (resmetirom)
adverse pregnancy and fetal outcomes
03/14/2024
Wainua (eplontersen)
adverse pregnancy and fetal outcomes
12/22/2023
Zepbound (tirzepatide)
adverse pregnancy and fetal outcomes
medullary thyroid carcinoma
11/03/2023
Voquezna (vonoprozan)
adverse pregnancy and fetal outcomes
11/01/2023
Omvoh (mirikizumab-mrkz)
adverse pregnancy and fetal outcomes
drug induced liver injury
10/26/2023
Bimzelx (bimekizumab-bkzx)
adverse pregnancy and fetal outcomes
drug induced liver injury
hematologic adverse reactions
hepatitis B reactivation
hypersensitivity reactions
inflammatory bowel disease (IBD)
major adverse cardiovascular events
malignancy
opportunistic infections
serious infections
tuberculosis (TB)
10/17/2023
Zilbrysq (zilucoplan)
adverse pregnancy and fetal outcomes
10/17/2023
Velsipity (etrasimod)
adverse pregnancy and fetal outcomes
10/12/2023
Exxua (gepirone hydrochloride)
adverse pregnancy and fetal outcomes
09/22/2023
Sohonos (palovarotene)
adverse pregnancy and fetal outcomes
flare ups
fractures
growth effects
08/16/2023
Vanflyta (quizartinib)
ventricular arrhythmia
07/24/2023
Leqembi (lecanemab-irmb)
amyloid related imaging abnormality-edema (ARIA-E)
amyloid related imaging abnormality-hemosiderin deposition (ARIA-H)
intracerebral hemorrhage (ICH)
07/06/2023
Rystiggo (rozanolixizumab-noli)
adverse pregnancy and fetal outcomes
06/26/2023
Litfulo (ritlecitinib)
adverse pregnancy and fetal outcomes
06/23/2023
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
adverse pregnancy and fetal outcomes
06/20/2023
Xacduro (sulbactam/durlobactam)
hypersensitivity reactions
05/23/2023
Elfabrio (pegunigalsidase alfa)
adverse pregnancy and fetal outcomes
05/09/2023
Zavzpret (zavegepant)
adverse pregnancy and fetal outcomes
03/09/2023
Skyclarys (omaveloxolone)
adverse pregnancy and fetal outcomes
02/28/2023
Filspari (sparsentan)
drug induced liver injury
02/17/2023
Jesduvroq (daprodustat)
adverse pregnancy and fetal outcomes
drug induced liver injury
gastrointestinal (GI) bleed
heart failure
major adverse cardiovascular events
malignancy
retinopathy proliferative
venous thromboembolism (VTE)
02/01/2023
Briumvi (ublituximab)
adverse pregnancy and fetal outcomes
12/28/2022
Fabhalta (iptacopan)
encapsulated bacterial infections
12/05/2022
Tzield (teplizumab-mzwv)
adverse pregnancy and fetal outcomes
cytokine release syndrome
hypersensitivity reactions
lymphoproliferative disorder
malignancy
serious infection
11/22/2022
Sezaby (phenobarbital sodium)
neurodevelopmental delays
11/17/2022
Sotyktu (deucravacitinib)
adverse pregnancy and fetal outcomes
09/09/2022
Xenpozyme (olipudase alfa-rpcp)
hypersensitivity reactions
infusion related reactions
laboratory abnormalities
08/31/2022
Amvuttra (vutrisiran)
adverse pregnancy and fetal outcomes
06/13/2022
Mounjaro (tirzepatide)
medullary thyroid carcinoma
05/13/2022
Voquezna Dual Pak (vonoprazan/amoxicillin)
adverse pregnancy and fetal outcomes
05/03/2022
Voquezna Triple Pak (vonoprazan/amoxicillin/clarithromycin)
adverse pregnancy and fetal outcomes
05/03/2022
Camzyos (mavacamten)
adverse pregnancy and fetal outcomes
04/28/2022
Enjaymo (sutimlimab-jome)
autoimmune disease
serious infection
02/04/2022
Cibinqo (abrocitinib)
adverse pregnancy and fetal outcomes
major adverse cardiovascular events
malignancy
thrombosis
01/14/2022
Rinvoq (upadacitinib)
adverse pregnancy and fetal outcomes
major adverse cardiovascular events
malignancy
thrombosis
01/14/2022
Quviviq (daridorexant)
adverse pregnancy and fetal outcomes
01/07/2022
Adbry (tralokinumab)
adverse pregnancy and fetal outcomes
12/27/2021
Leqvio (inclisiran)
adverse pregnancy and fetal outcomes
12/22/2021
Apretude (cabotegravir)
hiv seroconversion
insti resistance
12/20/2021
Vyvgart (efgartigimod alfa-fcab)
adverse pregnancy and fetal outcomes
12/17/2021
Zimhi (naloxone) 10/15/2021
Qulipta (atogepant)
adverse pregnancy and fetal outcomes
09/28/2021
Opzelura (ruxolitinib)
adverse pregnancy and fetal outcomes
09/21/2021
Saphnelo (anifrolumab-fnia)
adverse pregnancy and fetal outcomes
07/30/2021
Bylvay (odevixibat)
adverse maternal and neonatal outcomes
07/20/2021
Pradaxa (dabigatran etexilate)
major bleeding
thrombotic stroke
06/21/2021
Nexviazyme (avalglucosidase alfa)
adverse pregnancy and fetal outcomes
06/06/2021
Wegovy (semaglutide)
adverse pregnancy and infant outcomes
medullary thyroid cancer
06/04/2021
Brexafemme (ibrexafungerp)
adverse pregnancy and neonatal outcomes
06/01/2021
Myfembree (relugolix, estradiol, and norethindrone acetate)
adverse pregnancy and neonatal outcomes
alopecia
05/26/2021
Empaveli (pegcetacoplan)
autoimmune disease
encapsulated bacterial infections
05/14/2021
Nextstellis (drospirenone and estetrol)
arterial thromboembolism (ATE)
venous thromboembolism (VTE)
04/15/2021
Ponvory (ponesimod)
adverse pregnancy and fetal outcomes
03/18/2021
Verquvo (vericiguat)
adverse pregnancy and fetal outcomes
01/19/2021
Enspryng (satralizumab)
adverse pregnancy and fetal outcomes
08/14/2020
Lampit (nifurtimox)
adverse pregnancy and fetal outcomes
08/06/2020
Dojolvi (triheptanoin)
adverse pregnancy and fetal outcomes
06/30/2020
Fintepla (fenfluramine)
adverse pregnancy and fetal outcomes
pulmonary arterial hypertension
valvular heart disease
06/25/2020
Gimoti (metoclopramide nasal spray)
adverse central nervous system reactions
tardive dyskinesia
06/19/2020
Uplizna (inebilizumab-cdon)
adverse pregnancy and fetal outcomes
06/12/2020
Bafiertam (monomethyl fumarate)
adverse pregnancy and fetal outcomes
04/28/2020
Zeposia (ozanimod)
adverse pregnancy and fetal outcomes
03/20/2020
Nexletol (bempedoic acid)
adverse pregnancy and fetal outcomes
03/01/2020
Nurtec (rimegepant)
adverse pregnancy and fetal outcomes
02/27/2020
Nexlizet (bempedoic acid and ezetimibe)
adverse pregnancy and fetal outcomes
02/26/2020
Vyepti (eptinezumab)
adverse pregnancy and fetal outcomes
02/21/2020
Twirla (levonorgestrel and ethinyl estradiol)
arterial thromboembolism (ATE)
venous thromboembolism (VTE)
02/14/2020
Ubrelvy (ubrogepant)
adverse pregnancy and fetal outcomes
12/23/2019
Dayvigo (lemborexant)
adverse pregnancy and fetal outcomes
12/20/2019
Xcopri (cenobamate tablets)
adverse pregnancy and fetal outcomes
11/21/2019
Vumerity (diroximel fumarate)
adverse pregnancy and fetal outcomes
10/29/2019
Stelara (ustekinumab)
malignancy (ulcerative colitis)
serious infection (ulcerative colitis)
10/18/2019
Reyvow (lasmiditan)
adverse pregnancy and fetal outcomes
10/11/2019
Scenesse (afamelanotide)
implant site reactions
10/08/2019
Scenesse (afamelanotide) 10/08/2019
Ibsrela (tenapanor)
inflammatory bowel disease (IBD)
09/12/2019
Vyleesi (bremelanotide injection)
adverse pregnancy and fetal outcomes
06/21/2019
Ruzurgi (amifampridine)
adverse pregnancy and fetal outcomes
05/06/2019
Vyndamax (tafamidis)
adverse pregnancy and fetal outcomes
05/03/2019
Vyndaqel (tafamidis meglumine)
adverse pregnancy and fetal outcomes
05/03/2019
Skyrizi (risankizumab)
adverse pregnancy and fetal outcomes
lymphoma
malignancy
04/23/2019
Mayzent (siponimod)
adverse pregnancy and fetal outcomes
03/26/2019
Sunosi (solriamfetol)
adverse pregnancy and fetal outcomes
03/20/2019
Motegrity (prucalopride)
adverse pregnancy and fetal outcomes
12/14/2018
Firdapse (amifampridine phosphate)
adverse pregnancy and fetal outcomes
11/28/2018
Invokana (canagliflozin) 10/29/2018
Tegsedi (inotersen)
adverse pregnancy and fetal outcomes
cervicocephalic arterial dissection
cns vasculitis
glomerulonephritis
stroke
thrombocytopenia
10/05/2018
Emgality (galcanezumab)
adverse pregnancy and fetal outcomes
09/27/2018
Ajovy (fremanezumab)
adverse pregnancy and fetal outcomes
09/14/2018
Diacomit (stiripentol)
adverse pregnancy and fetal outcomes
08/20/2018
Annovera (segesterone acetate and ethinyl estradiol)
arterial thrombotic events
venous thromboembolism (VTE)
08/10/2018
Galafold (migalastat)
adverse pregnancy and fetal outcomes
08/10/2018
Arakoda (tafenoquine)
hematologic adverse reactions
neurological events
psychiatric events
08/08/2018
Epidiolex (cannabidiol)
adverse pregnancy and fetal outcomes
07/27/2018
Omegaven (fish oil triglycerides)
neurodevelopmental delays
pericardial effusions
pleural effusion
serious bleeding event
07/27/2018
Ablysinol (dehydrated alcohol)
atrioventricular block
death
heart failure
septal myectomy
ventricular arrhythmia
06/21/2018
Palynziq (pegvaliase)
adverse pregnancy and fetal outcomes
immune mediated adverse reactions
05/24/2018
Aimovig (erenumab)
adverse pregnancy and fetal outcomes
05/17/2018
Jynarque (tolvaptan)
drug induced liver injury
04/23/2018
Ilumya (tildrakizumab)
adverse pregnancy and fetal outcomes
lymphoma
malignancy
03/20/2018
Sinuva (mometasone furoate)
cataracts
glaucoma
nasal septal perforation
12/08/2017
Ozempic (semaglutide)
medullary thyroid cancer
12/05/2017
Mepsevii (vestronidase alfa) 11/15/2017
Tremfya (guselkumab)
adverse pregnancy and fetal outcomes
lymphoma
malignancy
07/13/2017
Tymlos (abaloparatide) 04/28/2017
Brineura (cerliponase alfa)
device related complications
hypersensitivity reactions
serious cardiovascular adverse events
04/27/2017
Ocrevus (ocrelizumab)
adverse pregnancy and fetal outcomes
malignancy
03/28/2017
Siliq (brodalumab)
adverse pregnancy and fetal outcomes
fatal major adverse cardiac events
hospitalized neutropenia
malignancy
myocardial infarction and stroke
opportunistic infections
outpatient neutropenia
serious infection
suicidal ideation and behavior
02/15/2017
Parsabiv (etelcalcetide)
gastrointestinal bleeding
02/07/2017
Adlyxin (lixisenatide) 07/26/2016
Relistor (methylnaltrexone)
major adverse cardiac events
07/19/2016
Probuphine (buprenorphine)
implant insertion removal complications
05/26/2016