How ARIA Analyses Have Been Used by FDA

This page summarizes how select analyses conducted in Sentinel's Active Risk Identification and Analysis (ARIA) system have been used by FDA since Sentinel's official launch in February 2016. ARIA can contribute to FDA’s regulatory process in a variety of ways, such as contributing evidence to support a label change, respond to a Citizens Petition, or become part of an Advisory Committee deliberation. Information from ARIA can also provide evidence that alleviates concerns about a particular safety issue and might lead FDA to determine that no regulatory action is necessary based on the available information.

Each ARIA analysis listed below contributed in some material way to inform an important regulatory discussion or action. FDA makes decisions about drug safety issues based upon the totality of evidence. The listing of an ARIA analysis in the table means that Sentinel’s ARIA system was one important source of evidence considered.

 

Drug Name

Outcome Assessed

ARIA Analysis

Regulatory Determination / Use

Date Posted
Multiple sclerosis (MS) drugs Exposure before, during, and after pregnancy Level 1

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

12/6/2018
Interleukin-1/-6 inhibitors Pulmonary arterial hypertension and interstitial lung disease Level 1

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

12/3/2018
Forteo (teriparatide) Duration of use Level 1

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

11/30/2018
Medications for attention deficit hyperactivity disorder Heart failure and cardiomyopathy Level 1

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.

8/30/2018
Actemra (tocilizumab) Exposure in pregnancy Level 1

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

8/7/2018
Multiple Drug utilization in pregnancy to evaluate enrollment in pregnancy registries compared with spontaneous reports  Prototype L1**

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

7/26/2018

Continuous or extended cycle oral contraceptives Venous thromboembolism Level 1, Level 2

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

3/5/2018
Sinuva (mometasone furoate) Cataracts and glaucoma Level 1

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

2/5/2018
None Respiratory syncytial virus associated illness (RSV-AI) Level 1

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

1/25/2018
TNF-alpha inhibitors Exposure in pregnancy Level 1

Drug Safety Label Change, Pregnancy and Lactation 

12/21/2017
Gadolinium-based contrast agents Exposure in pregnancy Level 1

Advisory Committee Presentation & FDA Drug Safety Communication

12/19/2017
Antipsychotic agents (including haloperidol injection) Ischemic and hemorrhagic stroke Level 1, Level 2

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.

12/8/2017
Ketoconazole oral tablets Drug use trends after safety label change and use in labeled indications Level 1

Citizen Petition Response

12/4/2017
Keppra (levetiracetam) Anaphylaxis and angioedema Level 1

Drug Safety Label Change, Warnings and Precautions

11/30/2017

How Mini-Sentinel Analyses Have Been Used By FDA

Drug Name

Outcome Assessed

Analysis

Regulatory Determination / Use

Date Posted

Intravenous iron products

Anaphylaxis

Protocol-based assessment

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

2/12/2018
Onglyza (saxagliptin) and Januvia (sitagliptin) Hospitalized heart failure Protocol-based assessment**

Advisory Committee Presentation 

2/2/2018
Onglyza (saxagliptin) and Januvia (sitagliptin) Acute myocardial infarction Protocol-based assessment**

Advisory Committee Presentation 

2/2/2018
Second generation antipsychotic agents Metabolic effects in children (Type 2 diabetes, metabolic syndrome, weight gain) Protocol-based assessment**

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

2/2/2018
Xarelto (rivaroxaban) Intracranial hemorrhage, gastrointestinal bleed, and ischemic stroke Level 3

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

1/24/2018
Olmesartan medoximil
Intestinal sprue
Level 1*

Safety Labeling Change, Warnings and Precautions; Drug Safety Communication

1/24/2018
Pradaxa (dabigatran etexilate) Intracranial hemorrhage, gastrointestinal bleed Level 1*

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

1/24/2018

*This query was performed using Mini-Sentinel’s Modular Program 3, the precursor to an ARIA L1 analysis.

**Complete results are contained in the associated publications and/or final written reports.