/**
* Recent Safety Alerts Resource
* Real-time FDA safety enforcement actions and recent safety alerts
*/
import { BaseResource, ResourceContent } from './base.js';
import { logger } from '../logging/index.js';
export class RecentSafetyAlertsResource extends BaseResource {
constructor() {
super(
'fda://safety/alerts/recent',
'Recent Safety Alerts',
'Recent FDA enforcement actions and safety alerts from the last 90 days',
'application/json'
);
}
async getContent(): Promise<ResourceContent> {
const requestId = `safety-alerts-${Date.now()}`;
try {
// Fetch recent FDA enforcement actions (safety-related recalls)
const enforcementUrl = 'https://api.fda.gov/drug/enforcement.json?search=classification:(Class+I+OR+Class+II)&sort=recall_initiation_date:desc&limit=50';
const enforcementResponse = await fetch(enforcementUrl);
if (!enforcementResponse.ok) {
throw new Error(`FDA Enforcement API error: ${enforcementResponse.status}`);
}
const enforcementData = await enforcementResponse.json();
const recentEnforcements = enforcementData?.results || [];
// Filter for recent safety-related enforcement actions (last 90 days)
const ninetyDaysAgo = new Date();
ninetyDaysAgo.setDate(ninetyDaysAgo.getDate() - 90);
const recentSafetyActions = recentEnforcements.filter((action: any) => {
if (!action.recall_initiation_date) return false;
const actionDate = new Date(
action.recall_initiation_date.slice(0, 4) + '-' +
action.recall_initiation_date.slice(4, 6) + '-' +
action.recall_initiation_date.slice(6, 8)
);
return actionDate >= ninetyDaysAgo && action.status !== 'Terminated';
});
// Categorize by severity and type
const alertsByClass = this.categorizeByClassification(recentSafetyActions);
const alertsByReason = this.categorizeByReason(recentSafetyActions);
const safetyAlerts = {
reportGenerated: new Date().toISOString(),
analysisWindow: "Last 90 days",
totalActiveAlerts: recentSafetyActions.length,
dataSource: "FDA Drug Enforcement Database (OpenFDA)",
urgentSafetyAlerts: recentSafetyActions
.filter((action: any) => action.classification === 'Class I')
.slice(0, 10)
.map((action: any) => ({
productName: action.product_description || 'Not specified',
classification: action.classification,
reason: action.reason_for_recall || 'Not specified',
recallingFirm: action.recalling_firm || 'Not specified',
initiationDate: this.formatDate(action.recall_initiation_date),
distributionPattern: action.distribution_pattern || 'Not specified',
status: action.status || 'Unknown',
recallNumber: action.recall_number || 'Not available'
})),
criticalSafetyAlerts: recentSafetyActions
.filter((action: any) => action.classification === 'Class II')
.slice(0, 15)
.map((action: any) => ({
productName: action.product_description || 'Not specified',
classification: action.classification,
reason: action.reason_for_recall || 'Not specified',
recallingFirm: action.recalling_firm || 'Not specified',
initiationDate: this.formatDate(action.recall_initiation_date),
distributionPattern: action.distribution_pattern || 'Not specified',
status: action.status || 'Unknown'
})),
alertsByClassification: alertsByClass,
alertsByReason: alertsByReason,
topSafetyReasons: Object.entries(alertsByReason)
.sort(([,a], [,b]) => (b as number) - (a as number))
.slice(0, 10)
.map(([reason, count]) => ({
reason: reason,
alertCount: count,
severity: this.assessReasonSeverity(reason)
})),
recentCriticalUpdates: recentSafetyActions
.sort((a: any, b: any) => b.recall_initiation_date.localeCompare(a.recall_initiation_date))
.slice(0, 5)
.map((action: any) => ({
date: this.formatDate(action.recall_initiation_date),
classification: action.classification,
product: action.product_description,
reason: action.reason_for_recall,
firm: action.recalling_firm
})),
summary: {
totalAlerts: recentSafetyActions.length,
classI: alertsByClass['Class I'] || 0,
classII: alertsByClass['Class II'] || 0,
ongoingActions: recentSafetyActions.filter((a: any) => a.status === 'Ongoing').length,
completedActions: recentSafetyActions.filter((a: any) => a.status === 'Completed').length
}
};
return {
uri: this.resourceUri,
mimeType: this.mimeType,
text: JSON.stringify(safetyAlerts, null, 2),
metadata: {
generatedAt: new Date().toISOString(),
dataFreshness: 'current',
contentSize: JSON.stringify(safetyAlerts).length,
dataSource: 'FDA OpenFDA Enforcement API',
lastQuery: new Date().toISOString()
}
};
} catch (error) {
logger.error('Failed to fetch current safety alerts', error as Error, {
component: 'CURRENT_SAFETY_ALERTS_RESOURCE',
requestId
});
const errorResponse = {
error: 'Failed to retrieve current safety alerts data',
message: (error as Error).message,
timestamp: new Date().toISOString(),
dataSource: 'FDA Drug Enforcement Database (OpenFDA) - Error occurred',
fallbackRecommendation: 'Check FDA enforcement database directly at https://www.accessdata.fda.gov/scripts/ires/'
};
return {
uri: this.resourceUri,
mimeType: this.mimeType,
text: JSON.stringify(errorResponse, null, 2),
metadata: {
generatedAt: new Date().toISOString(),
dataFreshness: 'error',
contentSize: JSON.stringify(errorResponse).length
}
};
}
}
private categorizeByClassification(actions: any[]): Record<string, number> {
const counts: Record<string, number> = {};
actions.forEach(action => {
const classification = action.classification || 'Unknown';
counts[classification] = (counts[classification] || 0) + 1;
});
return counts;
}
private categorizeByReason(actions: any[]): Record<string, number> {
const counts: Record<string, number> = {};
actions.forEach(action => {
const reason = this.extractMainReason(action.reason_for_recall || 'Unknown');
counts[reason] = (counts[reason] || 0) + 1;
});
return counts;
}
private extractMainReason(fullReason: string): string {
const reason = fullReason.toLowerCase();
if (reason.includes('sterility') || reason.includes('contamination') || reason.includes('microbiological')) {
return 'Sterility/Contamination';
} else if (reason.includes('potency') || reason.includes('strength') || reason.includes('dose')) {
return 'Potency/Strength Issues';
} else if (reason.includes('labeling') || reason.includes('label')) {
return 'Labeling Defects';
} else if (reason.includes('stability') || reason.includes('degradation') || reason.includes('impurity')) {
return 'Stability/Impurity';
} else if (reason.includes('manufacturing') || reason.includes('production') || reason.includes('facility')) {
return 'Manufacturing Defects';
} else if (reason.includes('packaging') || reason.includes('container')) {
return 'Packaging Defects';
} else if (reason.includes('cgmp') || reason.includes('compliance') || reason.includes('deviation')) {
return 'CGMP/Compliance Issues';
} else {
return 'Other Safety Issues';
}
}
private assessReasonSeverity(reason: string): string {
const highRisk = ['Sterility/Contamination', 'Potency/Strength Issues', 'CGMP/Compliance Issues'];
const mediumRisk = ['Manufacturing Defects', 'Stability/Impurity'];
const lowRisk = ['Labeling Defects', 'Packaging Defects'];
if (highRisk.includes(reason)) return 'High';
if (mediumRisk.includes(reason)) return 'Medium';
if (lowRisk.includes(reason)) return 'Low';
return 'Medium';
}
private formatDate(dateString: string): string {
if (!dateString || dateString.length !== 8) return 'Unknown';
const year = dateString.slice(0, 4);
const month = dateString.slice(4, 6);
const day = dateString.slice(6, 8);
return `${year}-${month}-${day}`;
}
}
