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Xarelto Liability Suit: Is Label 'Silent' About Increased Bleeding Risk?

 
• By Brenda Sandburg

Even after multiple bellweather wins, Janssen and Bayer still face claims they did not warn doctors about concomitant use with Plavix and aspirin; as case begins in Philadelphia, plaintiff's attorney tells jury the firms were 'silent,' while defense points to doctors' testimony that a different warning would not have changed their prescribing.

court house

PHILADELPHIA – Plaintiff's lawyers hammered one message to the jury in the opening of a Xarelto (rivaroxaban) product liability trial on April 6: Bayer AG and Janssen Pharmaceuticals Inc. were silent about the increased risk of bleeding in those who take the drug with Plavix (clopidogrel) and aspirin, two other blood thinners.

Before beginning his opening statement, Brian Barr, of Levin Papantonio, placed an easel with a large pad of paper in...

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MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 
• By Eliza Slawther

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.

Titanium Dioxide Stays: EU Decides Not To Pull Plug On Widely Used Excipient

 
• By Neena Brizmohun

While titanium dioxide is banned as a food additive in the EU, the European Medicines Agency has convinced the European Commission to allow its continued use in the many thousands of medicines in which it is currently used.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By Mandy Jackson

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

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New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

Could Study Questioning GLP-1 Cost Savings Impact CMMI Demo Chances?

 
• By Cathy Kelly

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