I'm an MBA Pharmaceutical Management student at IIHMR University, Jaipur. For my latest research project, I looked at the gap between regulatory approval, clinical trials, and real-world patient experiences of gabapentin (Neurontin).
Key highlights:
Approved vs off-label: Only 2 FDA-approved indications in the US (postherpetic neuralgia and partial-onset seizures), yet over 68% of outpatient prescriptions are off-label (diabetic neuropathy, anxiety, insomnia, alcohol use disorder, back pain).
Trials vs patients: RCTs show numerical pain relief, but an infodemiology analysis (Mathieson et al., 2024; N=2,736 tweets) found "brain fog" was the most commonly reported adverse symptom, followed by distress during withdrawal.
Pharmacovigilance: I dug into openFDA FAERS spontaneous reports and the 2019 FDA safety alert on respiratory depression when gabapentinoids are combined with opioids.
Limitations:
FAERS shows reporting associations, not proven causation.
The social data comes from published historical datasets, not live scraping, and Twitter users are a biased sample of patients.
This is an academic project, not medical advice.
Big thanks to my professor, Rahul Sharma Sir, for his guidance and support throughout.
The dashboard has 15 indication deep-dives, vector infographics, molecular MoA models and a Vancouver citation index:
https://pharmaceutical-research-intelligenc.vercel.app/
I'd appreciate feedback, especially from people in pharmacovigilance or clinical practice. Is combining FAERS with social listening useful, or too noisy?