Drug Assessments

The Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research (CDER) leads the Sentinel System. Sentinel was created to meet the mandate described in Section 905 of the Food and Drug Administration Amendments Act 2007 (FDAAA) to create an active postmarket drug safety surveillance system. CDER uses Sentinel to proactively assess the safety of FDA approved drugs under real-world conditions.


The Active Risk Identification and Analysis (ARIA) system is the largest and most developed component of Sentinel. ARIA uses state-of-the-art analysis tools and a distributed database of standardized claims and claims linked with EHR data to monitor the safety of medications. The data undergo continuous quality checks and refreshes. With ARIA, safety analyses are conducted more efficiently compared to studies with fully customized analytics—often in a matter of months, rather than several years. 

How Drug Safety Assessments Inform FDA’s Regulatory Process

FDA conducts safety assessments in Sentinel for the following purposes, as described in Section 505(o)(3)(B) of FDAAA:

  • Assess a known serious risk related to the use of the drug
  • Assess signals of serious risk related to the use of the drug
  • Identify an unexpected serious risk

Sentinel drug safety assessment can contribute to FDA’s regulatory process in a variety of ways. This includes:

  • Providing reassuring data to address new concerns about the safety of a medical product
  • Contributing evidence to support an FDA Drug Safety Communication or Label Change
  • Responding to a citizen's petition
  • Informing FDA’s risk management strategy for a drug
  • Becoming part of an Advisory Committee deliberation
  • Providing evidence that alleviates a drug safety concern

  • Signal Identification: assessments used to detect new and unsuspected potential safety concerns.
  • Level 1: assessments used to describe and characterize patterns of medication use or rates of health outcomes of interest. The Sentinel Query Builder application represents a subset of Level 1 functionality. Query Builder analyses are typically run on IBM® MarketScan® Research Databases but some are also run on Sentinel's distributed database.
  • Levels 2 and 3: assessments used to study whether a potential adverse health outcome is related to the use of drug and estimates the size of that risk.
     

Types of ARIA Analyses

The total number of assessments conducted by FDA in Sentinel’s ARIA system since its launch in 2016 are shown below. Summary table analyses were retired in September 2019 and replaced by more capable Query Builder analyses.

ARIA Analyses by Quarter

Sentinel’s ARIA system is complemented by EHR data systems, enabling the selection of a data source that best fits a drug safety question of interest. There are 3 categories of EHR data sources:

  • Data Aggregators: Compiles EHR data from multiple, discrete healthcare organizations in a single platform.
  • Data Warehouse: Stores extracted, standardized data from transactional systems in a central repository.
  • Network: An integrated partnership of standardized EHR data among multiple data partners.

Sentinel's Multi-Modal Response System

All drug safety assessments conducted in Sentinel are included below. The table is organized by the drug or population of interest and the health outcome(s) under study. When available, links are provided to the analytic code (package), results, communications and the study’s regulatory outcome.

Sentinel Drug Assessment Status

Sentinel Study Purpose

 

FDA Sentinel Drug Assessments: from ARIA and other Sentinel Data Sources

Drug/Population Safety Analysis Status Health Outcome(s) Impact(s) Posted Last Updated Purpose Original Posting Date Regulatory Determination / Use ARIA Results Analytic Code Regulatory Links Related Publications
Methotrexate, oral
Complete
Complete
wrong frequency dosing errors
Regulatory Outcome, Communication, Results 09/14/2021 Methods and Development

Low-dose oral methotrexate is associated with wrong frequency dosing errors, when taken once daily instead of the intended once weekly schedule. The Institute for Safe Medication Practices (ISMP) has classified methotrexate (oral, nononcologic use) as a high alert medication that can cause fatal and serious adverse events when mistakenly taken daily. However, the incidence of wrong frequency dosing errors with methotrexate is unknown. A chart confirmed analysis was conducted in one Sentinel Data Partner (Kaiser Permanente Northern California) and found the incidence of low-dose oral methotrexate wrong frequency dosing errors to be 0.4%. FDA used these findings to revise the methotrexate labeling in 2019, which included adding a new Warnings and Precautions section on the risk of improper dosing, removing an option for doses given every 12 hours for 3 days each week, and recommending that patients and caregivers be instructed to take methotrexate as directed as dosing errors have led to fatal toxicity. In July 2020, ISMP highlighted the labeling revision in their Medication Safety Alert! newsletter.

Yes /assessments/drugs/wrong-frequency-errors-low-dose-oral-methotrexate
Brilinta (ticagrelor)
Complete
Complete
concomitant use with Lipitor (atorvastatin) or Crestor (rosuvastatin)
Regulatory Outcome, Communication, Results 09/13/2021 Drug Use

This analysis provided information on concomitant utilization of ticagrelor and moderate/high-intensity statins. FDA received postmarket reports of statin-induced myopathy/rhabdomyolysis in elderly patients taking atorvastatin or rosuvastatin with ticagrelor. Considering that use of high-intensity statins is advised in secondary prevention following a myocardial infarction, FDA initiated this analysis to understand utilization patterns for patients concurrently taking ticagrelor and a statin and provide context for postmarket case reports. Our Sentinel analysis found that out of all ticagrelor 90mg exposures in patients ≥75 years, the proportion of concomitant use with high-intensity statins increased from 57% in 2012 to 66% in 2016. Based upon these data and analyses from other sources, FDA decided that no regulatory action was needed at this time.

/assessments/drugs/individual-drug-queries/concurrent-use-ticagrelor-atorvastatin-or-rosuvastatin
Eliquis (apixaban), Pradaxa (dabigatran), and Xarelto (rivaroxaban)
Complete
Complete Regulatory Outcome, Analytic Code, Communication, Results 05/24/2021 Drug and Outcome Analysis

Cases of severe uterine bleeding associated with use of novel oral anticoagulants (ACs) have been reported in the FDA Adverse Event Reporting System (FAERS) and the medical literature. FDA conducted a Sentinel study to examine severe uterine bleeding events requiring medical intervention in women treated with oral ACs. Among 1,050,192 new users of oral ACs, the incidence rates of severe uterine bleeding with medical, transfusion, and surgical (e.g., hysterectomy, myomectomy) management were 0.6, 1.7, and 5.0 per 1000 person-years, respectively. These findings contributed to the following class-wide label change for oral ACs in Section 8.3, “The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including [PRODUCT name] should be assessed in females of reproductive potential and those with abnormal uterine bleeding.”

Yes /assessments/drugs/incidence-severe-uterine-bleed-following-novel-oral-anticoagulants-use-descriptive, /assessments/drugs/severe-uterine-bleed-following-novel-oral-anticoagulants-use-propensity-score, /assessments/drugs/individual-drug-queries/incidence-rate-severe-uterine-bleeding-among-new-users
Entresto (sacubitril/​valsartan)
Ongoing
Ongoing Analytic Code 04/21/2021 Drug and Outcome Analysis Yes
Insulin
Complete
Complete Regulatory Outcome, Results 04/16/2021 Drug Use

In March 2020, insulins were transitioned from being regulated as drugs to being regulated as biological products. This transition allows for the introduction of biosimilars, which are highly similar to, and have no clinically meaningful differences from, their reference biological medication. To facilitate pharmacovigilance, an analysis was conducted to characterize how insulin was captured in electronic healthcare data sources, specifically via National Drug Codes (NDC) or Healthcare Common Procedure Coding System (HCPCS) codes. This analysis demonstrated that over 98% of the 107 million insulin claims in Sentinel between 2013 and 2018 were identified using NDC codes, supporting the use of NDCs to identify insulin exposure in drug safety studies using electronic healthcare data. Having a variety of different tools to identify products for pharmacovigilance is of high value. We have demonstrated that a large fraction of insulin use in Sentinel can be identified using NDCs. That, in addition to other identifiers, supports effective pharmacovigilance.

Yes /assessments/drugs/individual-drug-queries/patterns-insulin-product-use-and-billing-codes
Eliquis (apixaban), Pradaxa (dabigatran), and Xarelto (rivaroxaban)
Complete
Complete
cutaneous small-vessel vasculitis
Analytic Code, Results 11/02/2020 Drug and Outcome Analysis Yes /assessments/drugs/individual-drug-queries/cutaneous-small-vessel-vasculitis-following-dabigatran
Eliquis (apixaban), Pradaxa (dabigatran), and Xarelto (rivaroxaban)
Ongoing
Ongoing
gastrointestinal bleeding
intracranial hemorrhage
major extracranial bleeding
thromboembolic stroke
Analytic Code 10/30/2020 Drug and Outcome Analysis Yes
Infed (iron dextran), Venofer (iron sucrose), Feraheme (ferumoxytol), Injectafer (ferric carboxymaltose), Monoferric (ferric derisomaltose)
Complete
Complete
exposure in pregnancy
Regulatory Outcome, Results 10/13/2020 Drug Use

This analysis characterized the frequency of IV iron utilization by week relative to live birth and stillbirth deliveries. Information from this analysis contributed to a class-wide labeling update for parenteral iron products to add new safety information to the Use in Specific Populations, Pregnancy section of the label. This update describes the risk of severe adverse reactions to pregnant women and their fetus.

Yes /assessments/drugs/intravenous-iv-iron-utilization-among-pregnant-women
Hydrochlorothiazide
Complete
Complete
non-melanoma skin cancer
Regulatory Outcome, Analytic Code, Results 09/30/2020 Drug and Outcome Analysis

In response to observational studies showing an elevated risk of non-melanoma skin cancer associated with hydrochlorothiazide (HCTZ) use, FDA assessed the risk of non-melanoma skin cancer for patients treated with HCTZ-containing products compared to non-HCTZ angiotensin-converting-enzyme inhibitor (ACEI)-containing products in the Sentinel System. FDA found HCTZ is associated with an increased risk of non-melanoma skin cancer. In the Sentinel study, increased risk was predominantly for squamous cell carcinoma and in white patients taking large cumulative doses. These findings informed additions to the Adverse Reactions and Information for Patients sections of the label.

Yes /assessments/drugs/non-melanoma-skin-cancer-following-hydrochlorothiazide-use-propensity-score
Zantac (ranitidine)
Complete
Complete Regulatory Outcome, Results 09/15/2020 Drug Use

This analysis provided information on use patterns of prescription ranitidine in patients with Medicare and private health care insurance. These data, in addition to data from other sources, were used to provide context for CDER’s Nitrosamine Impurities Task Force to better understand the use patterns among U.S. individuals. These data also informed the feasibility of a Sentinel analysis to evaluate clinical outcomes associated with prescription ranitidine use.

Yes /assessments/drugs/ranitidine-drug-utilization-patterns
Gimoti (metoclopramide nasal spray)
Ongoing
Ongoing
adverse central nervous system reactions
tardive dyskinesia
07/10/2020 Drug and Outcome Analysis Yes
Singulair (montelukast)
Complete
Complete Neuropsychiatric adverse events consisting of:
inpatient depressive disorder
outpatient depressive disorder
self-harm
suicide
Regulatory Outcome, Analytic Code, Results 03/05/2020 Drug and Outcome Analysis

FDA presented a Sentinel study at a 2019 Advisory Committee of the risk of mental health side effects with montelukast compared to inhaled corticosteroids (ICS). In this study, FDA did not identify an elevated risk of hospitalized and treated outpatient depressive disorders, self-harm, and suicides among patients aged 6 years and older with asthma using montelukast compared to ICS. FDA also found no evidence that the risk of mental health side effects was modified by the 2008 FDA Early Communication. However, after reviewing the available information and convening a panel of outside experts, FDA strengthened the existing warnings about serious behavior and mood-related changes with montelukast by requiring a Boxed Warning because the benefits of montelukast may not outweigh the risks in patients with mild symptoms who could be adequately treated with other medicines.

Yes /drugs/assessments/neuropsychiatric-events-following-montelukast-use-propensity-score-matched
Anti-obesity medications (benzophetamine, bupropion/naltrexone, diethylpropion, liraglutide, lorcaserin, orlistat, phendimetrazine, phentermine, phentermine/topiramate)
Complete
Complete
duration of use
patient characteristics
Regulatory Outcome 11/13/2019 Drug Use

The Bipartisan Budget Act of 2018 (P.L. 115-123) included a provision for the Government Accountability Office (GAO) to review the prevalence of obesity and the use of obesity drugs. GAO requested that FDA assess utilization patterns and treatment duration for the nine available prescription used to treat obesity. FDA used the Sentinel System to assess the baseline characteristics of patients initiating weight management drugs and evaluate the duration of treatment of the first treatment episode and cumulative duration across all treatment episodes. These results were incorporated into the GAO report entitled, “Few Adults Used Prescription Drugs for Weight Loss and Insurance Coverage Varied.”

Yes
Opioid analgesics (excluding fentanyl products)
Complete
Complete
duration of follow-up
duration of use
Regulatory Outcome, Results 11/06/2019 Drug Use

FDA held an Advisory Committee (AC) meeting to discuss the definition of opioid-sparing and opioid-replacement analgesics, with particular attention to acute pain in the post-surgical setting. A Sentinel analysis was conducted to understand the variation in opioid use based upon surgical type. Sentinel data indicated that opioid exposure could be reduced among select surgical populations, particularly those undergoing less invasive procedures. However, the analysis also suggested that longer initial prescription durations might be appropriate in some cases and maintaining flexibility in prescribing options is essential to account for variation in opioid analgesic needs by patient as well as procedure.

Yes /drugs/assessments/optimal-initial-length-opioid-prescription, /drugs/assessments/estimating-optimal-quantities-initial-opioid-analgesic-prescriptions-acute-pain
Zydelig (idelalisib)
Complete
Complete Regulatory Outcome, Results 09/19/2019 Drug Use

Because the use of Zydelig in certain treatment regimens led to unacceptable levels of toxicity (pneumonitis, hepatitis, colitis), FDA evaluated the use of Zydelig concomitantly with other antineoplastic agents, in association with the labeled indication as well as other indications. The Sentinel analysis showed low observed rates of Zydelig concomitantly used with therapies which the labeled prescribing information describes as not indicated or not recommended. Based upon these data and analyses from other sources, FDA decided that no regulatory action was needed at this time.

Yes /drugs/assessments/concomitancy-and-indications-idelalisib-use
Ibsrela (tenapanor)
Ongoing
Ongoing
inflammatory bowel disease (IBD)
09/16/2019 Drug and Outcome Analysis Yes
Oxymorphone
Complete
Complete
concomitant use with cytochrome P450 (CYP) enzyme inhibitors
Regulatory Outcome, Communication, Results 09/04/2019 Drug Use

Drug-drug interactions are an important clinical concern. In a March 2017 Advisory Committee, briefing documents raised the possibility that oxymorphone may be used for a particular niche - patients taking multiple medications - because its metabolism did not involve the hepatic cytochrome P450 system. FDA conducted an analysis to assess whether oxymorphone’s metabolism influenced prescriber practices. Results revealed that similar proportions of patients were dispensed oxymorphone combined with other CYP modifiers relative to reference products, suggesting that drug metabolism differences did not influence prescribing behavior.

Yes /assessments/drugs/individual-drug-queries/concomitant-use-opioid-analgesics-and-cytochrome-p450-cyp
Higher dosage strength oral and transmucosal opioid analgesic products
Complete
Complete
patient characteristics
utilization patterns
Regulatory Outcome, Results 08/07/2019 Drug Use

FDA held an Advisory Committee (AC) meeting to better understand the use of higher dose opioid analgesics in the outpatient setting to inform a discussion of potential risk management strategies due to increasing public concern that these products may be more harmful in cases of accidental exposure and overdose, and may be more sought out for misuse and abuse. A Sentinel analysis was conducted to understand the current clinical use of higher dosage strength opioid analgesic products for pain management. Sentinel data indicated that patients on higher dosage strength opioid analgesic products had a higher prevalence of comorbidities, mental health disorders or substance abuse compared to patients on lower dosage strength opioid analgesic products. Moreover, the data showed that use of higher dosage strength products comprised a small proportion of all opioid use and has declined in recent years.

Yes /assessments/drugs/use-higher-dosage-strength-oral-and-transmucosal-opioid-analgesics
Qsymia (phentermine and topiramate extended release)
Complete
Complete
patient characteristics
Regulatory Outcome, Results 08/07/2019 Drug Use

Contributed important information regarding potentially viable sources of information to evaluate cardiovascular risk.

Yes /drugs/assessments/utilization-patterns-qsymia-phenterminetopiramate
Skyrizi (risankizumab)
Ongoing
Ongoing 08/06/2019 Drug and Outcome Analysis Yes
Lupron Depot-PED (leuprolide acetate)
Ongoing
Ongoing
any fracture (secondary)
hip replacement (secondary)
osteoporotic fracture
temporomandibular joint replacement (secondary)
Analytic Code 07/02/2019 Drug and Outcome Analysis Yes
Non-insulin antidiabetics
Complete
Complete
duration of follow-up
duration of use
Regulatory Outcome, Results 04/02/2019 Methods and Development

Feasibility assessment that supported an ARIA sufficiency determination to replace a sponsor postmarketing requirement (PMR) safety study for canagliflozin and renal cell carcinoma.

Yes /assessments/drugs/duration-follow-and-treatment-non-insulin-antidiabetic-drugs
Onglyza (saxagliptin) and Januvia (sitagliptin)
Complete
Complete
acute myocardial infarction (AMI)
heart failure
Analytic Code, Results 04/01/2019 Methods and Development Yes /drugs/assessments/acute-myocardial-infarction-and-hospitalized-heart-failure-following-saxagliptin
Sodium-glucose cotransporter-2 (SGLT-2) inhibitors
Complete
Complete
diabetic ketoacidosis (DKA)
use in type 1 diabetes mellitus (T1DM)
Regulatory Outcome, Communication, Results 04/01/2019 Drug and Outcome Analysis

In response to clinical trials showing an increased risk of DKA with sotagliflozin in T1DM, FDA assessed off-label use of SGLT2 inhibitors (approved for use in T2DM) and real-world rates of DKA when used in patients with T1DM. Elevated rates of DKA with off label SGLT2 inhibitor use among patients with T1DM were seen compared to clinical trials. These findings were presented at the Advisory Committee meeting for sotagliflozin, and this helped inform the committee member discussion on the benefit-risk assessment.

Yes /assessments/drugs/sglt-2-inhibitor-use-and-incidence-diabetic-ketoacidosis-patients-type-1-diabetes
Dolutegravir (Tivicay and combination products Juluca, Triumeq)
Complete
Complete
exposure in pregnancy
Regulatory Outcome, Communication, Results 03/28/2019 Drug Use

FDA assessed the feasibility of conducting a postmarket study in Sentinel to further investigate preliminary results from an observational study suggesting a higher risk of neural tube defects among offspring of pregnant women using dolutegravir (see the related FDA Drug Safety Communication below). The Sentinel query identified insufficient product exposure in pregnant women to support a robust safety assessment.

Yes /assessments/drugs/individual-drug-queries/dolutegravir-use-during-pregnancy
Phosphodiesterase type 5 (PDE5) inhibitors
Complete
Complete
exposure in pregnancy
Regulatory Outcome, Communication, Results 03/18/2019 Drug Use

Use of PDE5 inhibitors was assessed among reproductive age women, including among pregnant women, to investigate a concern arising from an international clinical trial.  FDA decided that no action is necessary at this time, based on available information.

Yes /assessments/drugs/individual-drug-queries/phosphodiesterase-type-5-pde-5-inhibitor-utilization
Uloric (febuxostat)
Complete
Complete
duration of use
user characteristics
Regulatory Outcome, Communication, Results 03/07/2019 Drug Use

FDA conducted a study to further investigate a post-market clinical trial that identified an elevated risk of cardiovascular events. Sentinel was used to describe the real-world utilization of urate lowering therapies to help inform the committee’s determination that a population exists for whom the benefit-risk is favorable.

Yes /assessments/drugs/individual-drug-queries/characteristics-gout-patients-and-use-urate-lowering
Invokana (canagliflozin)
Ongoing
Ongoing 03/04/2019 Drug and Outcome Analysis Yes
Eliquis (apixaban)
Complete
Complete
gastrointestinal (GI) bleed
intracranial hemorrhage
stroke
Analytic Code, Results 02/21/2019 Drug and Outcome Analysis Yes /assessments/drugs/individual-drug-queries/stroke-gastrointestinal-bleeding-and-intracranial
Ranexa (ranolazine)
Complete
Complete Regulatory Outcome, Analytic Code, Communication, Results 01/03/2019 Drug and Outcome Analysis

Combined with evidence from the Centers for Medicare & Medicaid Services, risk of seizure was determined to be driven primarily by underlying comorbidities. FDA decided that no action is necessary at this time, based on available information.

Yes /assessments/drugs/individual-drug-queries/seizure-following-ranolazine-use
Multiple sclerosis (MS) drugs
Complete
Complete
exposure before, during, and after pregnancy
Regulatory Outcome, Communication, Results 12/06/2018 Drug Use

Contextualized enrollment and recruitment in MS pregnancy registries. Described patterns of drug use before, during, and after pregnancy.

Yes /drugs/assessments/use-multiple-sclerosis-drugs-among-pregnant-women
Interleukin-1/-6 inhibitors
Complete
Complete
interstitial lung disease
pulmonary arterial hypertension
Regulatory Outcome, Results 12/03/2018 Drug and Outcome Analysis

Feasibility assessment of ARIA to conduct a postmarket safety study. FDA decided that no action is necessary at this time, based on available information.

Yes /assessments/drugs/individual-drug-queries/pulmonary-arterial-hypertension-and-interstitial-lung
Forteo (teriparatide)
Complete
Complete Regulatory Outcome, Results 11/30/2018 Drug Use

Contributed to the decision regarding continuation of sponsor Postmarket Requirement for teriparatide

Yes /assessments/drugs/individual-drug-queries/duration-use-teriparatide
Ablysinol (dehydrated alcohol)
Ongoing
Ongoing
atrioventricular block
death
heart failure
septal myectomy
ventricular arrhythmia
10/22/2018 Drug and Outcome Analysis Yes
Annovera (segesterone acetate and ethinyl estradiol vaginal system)
Ongoing
Ongoing Early Detection of:
arterial thromboembolism (ATE)
venous thromboembolism (VTE)
Results 09/24/2018 Drug and Outcome Analysis Yes /assessments/drugs/individual-drug-queries/venous-and-arterial-thromboembolism-among-new-users
Medications for attention deficit hyperactivity disorder
Complete
Complete
cardiomyopathy
heart failure
Regulatory Outcome, Communication, Results 08/30/2018 Drug and Outcome Analysis

Follow up investigation of case reports of cardiac events after long term stimulant use. FDA decided that no action is necessary at this time, based on available information.

Yes /drugs/assessments/adhd-medications-and-heart-failure
Actemra (tocilizumab)
Complete
Complete
exposure in pregnancy
Regulatory Outcome, Results 08/07/2018 Drug Use

Provided information to evaluate reported difficulties in enrollment in ongoing pregnancy registry

Yes /assessments/drugs/individual-drug-queries/actemra-tocilizumab-utilization-among-pregnant-women
Multiple
Complete
Complete
drug utilization in pregnancy to evaluate enrollment in pregnancy registries compared with spontaneous reports
Regulatory Outcome, Communication 07/26/2018 Mini-Sentinel

FDA is using these findings, in addition to input received from the 2014 FDA Public Meeting, to evaluate safety data collection in pregnant women

No
Ilumya (tildrakizumab)
Ongoing
Ongoing 05/25/2018 Drug and Outcome Analysis Yes
Continuous or extended cycle oral contraceptives
Complete
Complete
venous thromboembolism (VTE)
Regulatory Outcome, Analytic Code, Communication, Results 03/05/2018 Drug and Outcome Analysis

FDA decided that no action is necessary at this time, based on available information.

Yes /assessments/drugs/individual-drug-queries/combined-oral-contraceptives-containing-ethinyl-estradiol, /assessments/drugs/individual-drug-queries/venous-thromboembolism-following-continuous-or-extended
Intravenous iron products
Complete
Complete Regulatory Outcome, Results 02/12/2018 Mini-Sentinel

FDA decided that no action is necessary at this time, based on available information.

No /drugs/assessments/parenteral-iron-and-anaphylactoid-reactions
Onglyza (Saxagliptin) and Januvia (Sitagliptin)
Complete
Complete
Hospitalized heart failure
acute myocardial infarction (AMI)
Regulatory Outcome, Communication, Results 02/02/2018 Mini-Sentinel

Advisory Committee Presentation 

No /assessments/drugs/individual-drug-queries/anti-diabetes-drugs-and-acute-myocardial-infarction
Second generation antipsychotic agents
Complete
Complete
Achilles tendon rupture (ATR)
Metabolic effects in children (Type 2 diabetes, metabolic syndrome, weight gain)
Regulatory Outcome, Communication, Results 02/02/2018 Mini-Sentinel

FDA decided that no new action on behalf of pediatrics is necessary at this time, based on available information.

No /drugs/assessments/metabolic-effects-second-generation-antipsychotics-youth-subprojects-1-2-and-3
None
Complete
Complete
respiratory syncytial virus-associated illness
Regulatory Outcome, Results 01/25/2018 Other Regulatory

Epidemiological assessment of RSV-AI and patterns of health care utilization to help inform development of novel RSV therapeutics

Yes /assessments/drugs/individual-drug-queries/characterization-pediatric-medical-conditions-respiratory
Olmesartan medoximil
Complete
Complete Regulatory Outcome, Results 01/24/2018 Mini-Sentinel

Safety Labeling Change, Warnings and Precautions; Drug Safety Communication

No /assessments/drugs/individual-drug-queries/drugs-act-renin-angiotensin-aldosterone-system
Pradaxa (dabigatran etexilate)
Complete
Complete
gastrointestinal (GI) bleed
intracranial hemorrhage
Regulatory Outcome, Communication, Results 01/24/2018 Mini-Sentinel

FDA decided that no action is necessary at this time, based on available information.

No /assessments/drugs/individual-drug-queries/dabigatran-pradaxa-warfarin-and-gi-bleed-intracerebral
Xarelto (rivaroxaban)
Complete
Complete
gastrointestinal (GI) bleed
intracranial hemorrhage
ischemic stroke
Regulatory Outcome, Communication, Results 01/24/2018 Mini-Sentinel

FDA decided that no action is necessary at this time, based on available information.

No /assessments/drugs/individual-drug-queries/prompt-rivaroxaban-surveillance
TNF-alpha inhibitors
Complete
Complete
exposure in pregnancy
Regulatory Outcome, Communication, Results 12/21/2017 Drug Use

Drug Safety Label Change, Pregnancy and Lactation

Yes /assessments/drugs/individual-drug-queries/anti-tumor-necrosis-factor-tnf-utilization-among-pregnant
Gadolinium-based contrast agents
Complete
Complete
exposure in pregnancy
Regulatory Outcome, Communication, Results 12/19/2017 Drug Use

Advisory Committee Presentation & FDA Drug Safety Communication

Yes /drugs/assessments/gadolinium-based-contrast-agents-gbcas-use-pregnancy
Sinuva (mometasone furoate)
Ongoing
Ongoing
cataracts
diminished visual acuity
glaucoma
nasal septal perforation
Regulatory Outcome, Results 12/18/2017 Drug and Outcome Analysis

Feasibility assessment of ARIA sufficiency to replace a sponsor postmarketing requirement (PMR) safety study for Sinuva (mometasone furoate)

Yes /assessments/drugs/individual-drug-queries/sinus-stents-mometasone-and-diminished-visual-acuity
Antipsychotic agents (including haloperidol injection)
Complete
Complete Regulatory Outcome, Analytic Code, Communication, Results 12/08/2017 Drug and Outcome Analysis

Sentinel data was used to support decisions around potential labeling changes for antipsychotics and stroke risk. FDA decided that no action is necessary at this time, based on available information.

Yes /drugs/assessments/antipsychotics-and-stroke, /assessments/drugs/individual-drug-queries/stroke-following-typical-or-atypical-antipsychotic-use, /assessments/drugs/individual-drug-queries/stroke-following-atypical-antipsychotic-or-z-hypnotic-use
Ketoconazole oral tablets
Complete
Complete
drug use trends after safety label change and use in labeled indications
Regulatory Outcome, Results 12/04/2017 Drug Use

Citizen Petition Response

Yes /assessments/drugs/individual-drug-queries/indications-use-among-oral-antifungal-drug-users
Keppra (levetiracetam)
Complete
Complete
anaphylaxis
angioedema
Regulatory Outcome, Results 11/30/2017 Mini-Sentinel

Drug Safety Label Change, Warnings and Precautions

No /drugs/assessments/aeds-and-angioedema
Tremfya (guselkumab)
Ongoing
Ongoing 09/29/2017 Drug and Outcome Analysis Yes
Gadolinium-based contrast agents
Ongoing
Ongoing 08/23/2017 Drug and Outcome Analysis Yes
Siliq (brodalumab)
Ongoing
Ongoing
hospitalized neutropenia
myocardial infarction and stroke
serious infection
08/23/2017 Drug and Outcome Analysis Yes
Stelara (ustekinumab)
Ongoing
Ongoing 08/23/2017 Drug and Outcome Analysis Yes