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Invokana Adds Warnings On Amputation Risk, But Will It Give Jardiance An Edge?

 
• By Brenda Sandburg

New data from J&J's cardiovascular outcomes trials shows leg and foot amputations occurred about twice as often in diabetes patients treated with canagliflozin versus placebo.

FDA is requiring a boxed warning on Johnson & Johnson's Invokana (canagliflozin), Invokamet (canagliflozin/metformin) and Invokamet XR labeling about the increased risk of leg and foot amputations in patients taking the diabetes medicines.

The agency issued a safety announcement May 16 confirming the risk based on new data from J&J's two...

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Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

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‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Podium Policy Returns To US FDA, Or Is It Podcast Policy?

 
• By Michael McCaughan

US FDA critics have long decried the practice of using informal communications to convey regulatory expectations as podium policy. In the Makary era, the phrase may need to be updated because the agency now seems to be specializing in policy by podcast.