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)
Brexafemme (ibrexafungerp)
adverse pregnancy and neonatal outcomes
06/01/2021
Nextstellis (drospirenone and estetrol)
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
06/25/2020
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
Nurtec (rimegepant)
adverse pregnancy and fetal outcomes
02/27/2020
Vyepti (eptinezumab)
adverse pregnancy and fetal outcomes
02/21/2020
Twirla (levonorgestrel and ethinyl estradiol)
arterial thromboembolism (ATE)
venous thromboembolism (VTE)
02/14/2020
Xcopri (cenobamate tablets)
adverse pregnancy and fetal outcomes
11/21/2019
Vumerity (diroximel fumarate)
adverse pregnancy and fetal outcomes
10/29/2019
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
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
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
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
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
malignancy
opportunistic infections
outpatient neutropenia
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