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
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Drug/Population | Health Outcome(s) | Approval Date |
---|---|---|
Amvuttra (vutrisiran) | adverse pregnancy and fetal outcomes |
06/13/2022 |
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 |
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) | needlestick injury |
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) | skin cancer |
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) | renal cell carcinoma |
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) | anaphylaxis |
11/15/2017 |
Tremfya (guselkumab) | adverse pregnancy and fetal outcomes , lymphoma , malignancy |
07/13/2017 |
Tymlos (abaloparatide) | osteosarcoma |
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) | anaphylaxis |
07/26/2016 |
Relistor (methylnaltrexone) | major adverse cardiac events |
07/19/2016 |
Probuphine (buprenorphine) | implant insertion removal complications |
05/26/2016 |