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)
Adbry (tralokinumab)
adverse pregnancy and fetal outcomes
 12/27/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761180Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761180Orig1s000OtherR.pdf
Leqvio (inclisiran)
adverse pregnancy and fetal outcomes
 12/22/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214012Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/214012Orig1s000OtherR.pdf
Vyvgart (efgartigimod alfa-fcab)
adverse pregnancy and fetal outcomes
 12/17/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761195Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/761195Orig1s000OtherR.pdf
Zimhi (naloxone)
needlestick injury
 10/15/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/212854Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/212854Orig1s000OtherR.pdf
Qulipta (atogepant)
adverse pregnancy and fetal outcomes
 09/28/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215206Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215206Orig1s000OtherR.pdf
Opzelura (ruxolitinib)
adverse pregnancy and fetal outcomes
 09/21/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215309Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/215309Orig1s000OtherR.pdf
Saphnelo (anifrolumab fnia)
adverse pregnancy and fetal outcomes
 07/30/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761123Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/761123Orig1s000OtherR.pdf
Brexafemme (ibrexafungerp)
adverse pregnancy and neonatal outcomes
 06/01/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214900Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214900Orig1s000OtherR.pdf
Myfembree (relugolix, estradiol, and norethindrone acetate)
adverse pregnancy and neonatal outcomes
alopecia
 05/26/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214846Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214846Orig1s000OtherR.pdf
Nextstellis (drospirenone and estetrol)
venous thromboembolism (VTE)
 04/15/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214154Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214154Orig1s000OtherR.pdf
Ponvory (ponesimod)
adverse pregnancy and fetal outcomes
 03/18/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213498Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/213498Orig1s000OtherR.pdf
Verquvo (vericiguat)
adverse pregnancy and fetal outcomes
 01/19/2021 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214377Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/214377Orig1s000TOC.cfm
Enspryng (satralizumab)
adverse pregnancy and fetal outcomes
 08/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761149Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761149Orig1s000TOC.cfm
Lampit (nifurtimox)
adverse pregnancy and fetal outcomes
 08/06/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213464Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213464Orig1s000TOC.cfm
Dojolvi (triheptanoin)
adverse pregnancy and fetal outcomes
 06/30/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213687Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213687Orig1s000TOC.cfm
Fintepla (fenfluramine)
adverse pregnancy and fetal outcomes
 06/25/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212102Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212102Orig1s000TOC.cfm
Gimoti (metoclopramide nasal spray)
adverse central nervous system reactions
tardive dyskinesia
 06/19/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/209388Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/209388Orig1s000OtherR.pdf
Uplizna (inebilizumab-cdon)
adverse pregnancy and fetal outcomes
 06/12/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761142Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761142Orig1s000TOC.cfm
Bafiertam (monomethyl fumarate)
adverse pregnancy and fetal outcomes
 04/28/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/210296Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/210296Orig1s000TOC.cfm
Zeposia (ozanimod)
adverse pregnancy and fetal outcomes
 03/20/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209899Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/209899Orig1s000TOC.cfm
Nurtec (rimegepant)
adverse pregnancy and fetal outcomes
 02/27/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212728Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212728Orig1s000TOC.cfm
Vyepti (eptinezumab)
adverse pregnancy and fetal outcomes
 02/21/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761119Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761119Orig1s000OtherR.pdf
Twirla (levonorgestrel and ethinyl estradiol)
arterial thromboembolism (ATE)
venous thromboembolism (VTE)
 02/14/2020 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/204017Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/204017Orig1s000TOC.cfm
Dayvigo (lemborexant)
adverse pregnancy and fetal outcomes
 12/20/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212028Orig1s000TOC.cfm, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212028Orig1s000OtherR.pdf
Xcopri (cenobamate tablets)
adverse pregnancy and fetal outcomes
 11/21/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212839Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212839Orig1s000TOC.cfm
Vumerity (diroximel fumarate)
adverse pregnancy and fetal outcomes
 10/29/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211855Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211855Orig1s000TOC.cfm
Ibsrela (tenapanor)
inflammatory bowel disease (IBD)
 09/12/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211801Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211801Orig1s000TOC.cfm
Vyleesi (bremelanotide injection)
adverse pregnancy and fetal outcomes
 06/21/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000TOC.cfm
Ruzurgi (amifampridine)
adverse pregnancy and fetal outcomes
 05/06/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209321Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209321Orig1s000TOC.cfm
Vyndamax (tafamidis)
adverse pregnancy and fetal outcomes
 05/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211996Orig1s000,%20212161Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211996Orig1s000,%20212161Orig1s000TOC.cfm
Vyndaqel (tafamidis meglumine)
adverse pregnancy and fetal outcomes
 05/03/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211996Orig1s000,%20212161Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211996Orig1s000,%20212161Orig1s000TOC.cfm
Skyrizi (risankizumab)
adverse pregnancy and fetal outcomes
malignancy
 04/23/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761105Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761105Orig1s000TOC.cfm
Mayzent (siponimod)
adverse pregnancy and fetal outcomes
 03/26/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209884Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209884Orig1s000TOC.cfm
Sunosi (solriamfetol)
adverse pregnancy and fetal outcomes
 03/20/2019 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211230Orig1Orig2s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211230Orig1Orig2s000TOC.cfm
Motegrity (prucalopride)
adverse pregnancy and fetal outcomes
 12/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210166Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210166Orig1s000TOC.cfm
Firdapse (amifampridine phosphate)
adverse pregnancy and fetal outcomes
 11/28/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208078Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208078Orig1_toc.cfm
Tegsedi (inotersen)
adverse pregnancy and fetal outcomes
cervicocephalic arterial dissection
cns vasculitis
glomerulonephritis
stroke
thrombocytopenia
 10/05/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211172Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211172Orig1s000TOC.cfm
Emgality (galcanezumab)
adverse pregnancy and fetal outcomes
 09/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761063Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761063Orig1s000TOC.cfm
Ajovy (fremanezumab)
adverse pregnancy and fetal outcomes
 09/14/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761089Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761089Orig1s000TOC.cfm
Diacomit (stiripentol)
adverse pregnancy and fetal outcomes
 08/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000TOC.cfm
Annovera (segesterone acetate and ethinyl estradiol)
arterial thrombotic events
venous thromboembolism (VTE)
 08/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209627Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209627Orig1s000TOC.cfm
Galafold (migalastat)
adverse pregnancy and fetal outcomes
 08/10/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208623Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/208623Orig1s000TOC.cfm
Arakoda (tafenoquine)
hematologic adverse reactions
neurological events
psychiatric events
 08/08/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210607Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210607Orig1s000TOC.cfm
Epidiolex (cannabidiol)
adverse pregnancy and fetal outcomes
 07/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm
Omegaven (fish oil triglycerides)
neurodevelopmental delays
pericardial effusions
pleural effusion
serious bleeding event
 07/27/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210589Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210589Orig1s000TOC.cfm
Ablysinol (dehydrated alcohol)
atrioventricular block
death
heart failure
septal myectomy
ventricular arrhythmia
 06/21/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207987Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/207987Orig1s000TOC.cfm
Palynziq (pegvaliase)
adverse pregnancy and fetal outcomes
immune mediated adverse reactions
 05/24/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761079Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761079Orig1s000TOC.cfm
Aimovig (erenumab)
adverse pregnancy and fetal outcomes
 05/17/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761077Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761077Orig1s000TOC.cfm
Jynarque (tolvaptan)
drug induced liver injury
 04/23/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/204441Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/204441Orig1s000TOC.cfm
Ilumya (tildrakizumab)
adverse pregnancy and fetal outcomes
malignancy
 03/20/2018 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761067Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761067Orig1s000TOC.cfm
Sinuva (mometasone furoate)
cataracts
glaucoma
nasal septal perforation
 12/08/2017 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209310Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209310Orig1s000TOC.cfm
Ozempic (semaglutide)
medullary thyroid cancer
 12/05/2017 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209637Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209637Orig1s000TOC.cfm
Mepsevii (vestronidase alfa)
anaphylaxis
 11/15/2017 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761047Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761047Orig1s000TOC.cfm
Tremfya (guselkumab)
adverse pregnancy and fetal outcomes
malignancy
 07/13/2017 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761061Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761061Orig1s000TOC.cfm
Tymlos (abaloparatide)
osteosarcoma
 04/28/2017 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000TOC.cfm
Brineura (cerliponase alfa)
device related complications
hypersensitivity reactions
serious cardiovascular adverse events
 04/27/2017 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761052Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761052Orig1s000TOC.cfm
Ocrevus (ocrelizumab)
adverse pregnancy and fetal outcomes
malignancy
 03/28/2017 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000TOC.cfm
Siliq (brodalumab)
adverse pregnancy and fetal outcomes
fatal major adverse cardiac events
malignancy
opportunistic infections
outpatient neutropenia
suicidal ideation and behavior
 02/15/2017 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761032Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761032Orig1s000TOC.cfm
Parsabiv (etelcalcetide)
gastrointestinal bleeding
 02/07/2017 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208325Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208325Orig1s000TOC.cfm
Adlyxin (lixisenatide)
anaphylaxis
 07/26/2016 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208471Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208471Orig1s000TOC.cfm
Relistor (methylnaltrexone)
major adverse cardiac events
 07/19/2016 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208271Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208271Orig1s000TOC.cfm
Probuphine (buprenorphine)
implant insertion removal complications
 05/26/2016 https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204442Orig1s000OtherR.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/204442Orig1s000TOC.cfm
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