Data Dose December 2024 #3
Off-Label Marketing vs. Off-Label Use: A Thin Line in Pharmacovigilance
The line between medical innovation and regulatory violation becomes blurry when it comes to drug safety. While off-label use—prescribing medications for conditions not officially approved—has contributed to new therapeutic discoveries, the dynamics shift when off-label marketing is involved. This can prioritize corporate interests over patient safety, leading to potential risks. For pharmacovigilance specialists, this presents the challenge of monitoring unintended outcomes while maintaining the integrity of drug use. How can we strike a balance that ensures patient benefits without exposing them to avoidable harm? Read more...
Potential Eye Risks Linked to Popular Diabetes Drug Ozempic in Recent Danish Studies
Danish health authorities are urging the European Union's drug regulator to review two studies linking Novo Nordisk's diabetes drug, Ozempic, to non-arteritic anterior ischemic optic neuropathy (NAION), a severe eye condition. Research from the University of Southern Denmark suggests that Ozempic use more than doubles the risk of NAION in individuals with type 2 diabetes. Read more...
Recommended by LinkedIn
New drug shows potential in treating Duchenne muscular dystrophy
A new drug shows promise for Duchenne muscular dystrophy (DMD), a rare genetic disorder causing severe muscle degeneration.McGill University researchers discovered K884, an experimental compound that enhances muscle stem cell repair, addressing the root cause rather than just slowing damage.DMD affects 1 in 5,000 boys globally, often leading to severe disability by adolescence. "Strengthening muscle repair could improve quality of life and restore independence," said Natasha Chang, Assistant Professor at McGill. Read more...
Proactive Pharmacovigilance is the Game Changer Biotech Needs
The traditional approach to pharmacovigilance (PV) often involves waiting for conclusive summary data before addressing trends, a practice that can leave patients vulnerable and expose companies to future risks. Instead, the industry must embrace a forward-thinking approach—what I call “proactive pharmacovigilance.” By acting on emerging data trends early, PV can shift from a reactive process to one that prioritizes patient safety and risk mitigation before issues escalate. Read more...