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.

 

Drug NameOutcome AssessedRelated LinksDate of Drug Approval Action
Xcopri (cenobamate tablets)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

11/21/2019
Vumerity (diroximel fumarate)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

10/29/2019
Ibsrela (tenapanor)
  • Inflammatory bowel disease

ARIA Memo

FDA Approval Package

9/12/2019
Vyleesi (bremelanotide injection)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

6/21/2019
Ruzurgi (amifampridine)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

5/6/2019
Vyndamax (tafamidis)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

5/3/2019
Vyndaqel (tafamidis meglumine)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

5/3/2019
Skyrizi (risankizumab)
  • malignancy
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

4/23/2019
Mayzent (siponimod)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

3/26/2019
Sunosi (solriamfetol)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

3/20/2019
Motegrity (prucalopride)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

12/14/2018
Firdapse (amifampridine phosphate)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

11/28/2018
Tegsedi (inotersen)
  • adverse pregnancy and fetal outcomes
  • thrombocytopenia
  • glomerulonephritis
  • stroke
  • cns vasculitis
  • cervicocephalic arterial dissection

ARIA Memo

FDA Approval Package

10/5/2018
Emgality (galcanezumab)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

9/27/2018
Ajovy (fremanezumab)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

9/14/2018
Diacomit (stiripentol)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

8/20/2018
Annovera (segesterone acetate and ethinyl estradiol)
  • arterial thrombotic events
  • venous thromboembolism

ARIA Memo

FDA Approval Package

8/10/2018
Galafold (migalastat)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

8/10/2018
Arakoda (tafenoquine)
  • neurologic events
  • psychiatric events
  • hematologic adverse reactions

ARIA Memo

FDA Approval Package

8/8/2018
Epidiolex (cannabidiol)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

7/27/2018
Omegaven (fish oil triglycerides)
  • serious bleeding events
  • neurodevelopmental delays
  • pleural effusion
  • spericardial effusions

ARIA Memo

FDA Approval Package

7/27/2018
Ablysinol (dehydrated alcohol)
  • heart failure
  • ventricular arrhythmia
  • atrioventricular block
  • septal myectomy
  • death

ARIA Memo

FDA Approval Package

6/21/2018
Palynziq (pegvaliase)
  • immune mediated adverse reactions
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

5/24/2018
Aimovig (erenumab)
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

5/17/2018
Jynarque (tolvaptan)
  • drug induced liver injury

ARIA Memo

FDA Approval Package

4/23/2018
Ilumya (tildrakizumab)
  • malignancy
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

3/20/2018
Sinuva (mometasone furoate)
  • glaucoma
  • cataracts
  • nasal septal perforation

ARIA Memo

FDA Approval Package

12/8/2017
Ozempic (semaglutide)
  • medullary thyroid cancer

ARIA Memo

FDA Approval Package

12/5/2017
Mepsevii (vestronidase alfa)
  • anaphylaxis

ARIA Memo

FDA Approval Package

11/15/2017
Tremfya (guselkumab)
  • adverse pregnancy and fetal outcomes
  • malignancy

ARIA Memo

FDA Approval Package

7/13/2017
Tymlos (abaloparatide)
  • osteosarcoma

ARIA Memo

FDA Approval Package

4/28/2017
Brineura (cerliponase alfa)
  • hypersensitivity reactions
  • serious cardiovascular adverse events
  • device related complications

ARIA Memo

FDA Approval Package

4/27/2017
Ocrevus (ocrelizumab)
  • adverse pregnancy and fetal outcomes
  • malignancy

ARIA Memo

FDA Approval Package

3/28/2017
Siliq (brodalumab)
  • suicidal ideation and behavior
  • outpatient neutropenia
  • opportunistic infections
  • malignancy
  • fatal major adverse cardiac events
  • adverse pregnancy and fetal outcomes

ARIA Memo

FDA Approval Package

2/15/2017
Parsabiv (etelcalcetide)
  • gastrointestinal bleeding

ARIA Memo

FDA Approval Package

2/7/2017
Adlyxin (lixisenatide)
  • anaphylaxis

ARIA Memo

FDA Approval Package

7/27/2016
Relistor (methylnaltrexone)
  • major adverse cardiac events

ARIA Memo

FDA Approval Package

7/19/2016
Probuphine (buprenorphine)
  • implant insertion removal complications

ARIA Memo

FDA Approval Package

5/26/2016
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