FDA: JAK inhibitor boxed warning expansion

The FDA announced updated prescribing information for the JAK inhibitor class, expanding the existing boxed warning to incorporate new post-marketing venous thromboembolism data. The update affects tofacitinib, baricitinib, upadacitinib, and abrocitinib.

The expanded warning draws on Sentinel System analyses covering approximately 380,000 JAK inhibitor-exposed patients since the initial ORAL Surveillance-driven label changes in 2021. The new data identifies a dose-dependent VTE signal that persists across indications — rheumatoid arthritis, atopic dermatitis, and ulcerative colitis — suggesting a class-level mechanism rather than an indication-specific confounder.

What this means for practice: Prescribers should reassess VTE risk factors before initiating or continuing JAK inhibitor therapy. The update does not change approved indications but strengthens the risk-benefit conversation required at the point of prescribing.

EMA: fluoroquinolone referral concludes

The EMA completed its Article 31 referral on the risk of tendon disorders associated with fluoroquinolone antibiotics in elderly patients. The review, triggered by accumulated post-marketing data from EudraVigilance showing disproportionate tendon rupture reporting in patients over 65, resulted in strengthened warnings and a recommendation to restrict fluoroquinolone use in this population to infections with no alternative treatment.

The referral reviewed over 12,000 spontaneous reports of tendon-related adverse events associated with fluoroquinolones across the EU, with approximately 40% occurring in patients aged 65 and over. The PRAC concluded that age-related tendon degeneration creates a biologically plausible vulnerability to fluoroquinolone-induced tendinopathy.

MHRA: opioid deprescribing guidance

The MHRA published new guidance on the safe management of opioid deprescribing, addressing a growing safety concern: adverse events associated with overly rapid dose reduction or abrupt discontinuation of chronic opioid therapy. The guidance follows reports of serious withdrawal syndromes, psychological distress, and in rare cases, suicidal ideation linked to rapid opioid tapering.

What this means for practice: The guidance recommends individualized tapering schedules, typically reducing doses by no more than 10% per month, with enhanced monitoring during the deprescribing period.