1. Scrip
  2. >>Therapy Areas
  3. >>Musculoskeletal

FDA updates Arava label to include sterner liver safety warning

 
• By Asher Mullard

The US FDA is updating the black box warning on Sanofi-Aventis's rheumatoid arthritis drug Arava (leflunomide) to highlight the risk of severe liver injury in patients taking the drug. Arava already has a black box warning noting that the drug cannot be used in pregnant women due to risk of causing fetal harm. It also has a bolded warning, added in 2003, about the risk of liver injury.

The US FDA is updating the black box warning on Sanofi-Aventis's rheumatoid arthritis drug Arava (leflunomide) to highlight the risk of severe liver injury in patients taking the drug. Arava already has a black box warning noting that the drug cannot be used in pregnant women due to risk of causing fetal harm. It also has a bolded warning, added in 2003, about the risk of liver injury.

"The decision to add information on severe liver injury to the Boxed Warning was based on FDA's 2010 review of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Musculoskeletal

More Pressure on Elevidys As The EU’s CHMP Says ‘No’

 
• By Alexandra Shimmings

Just days after Roche stopped shipments of the DMD gene therapy following safety concerns raised by two patient deaths, its EU approval application has hit a block.

Capricor Gets Complete Response For DMD Cell Therapy

 
• By Joseph Haas

Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.

Ultragenyx and Mereo Still Confident Despite Setrusumab Slip Up

 
• By Kevin Grogan

The osteogenesis imperfecta drug stumbled in a second interim analysis.

Taiho’s Oral, Mutation-Agnostic DMD Candidate Misses Phase III Endpoint

 
• By Lisa Takagi

The oral, twice-daily candidate was expected to control decline in motor function in DMD patients regardless of their gene mutations.

More from Therapeutic Category

Biogen Edges Closer To Growth On Strong Q2

 
• By Jessica Merrill

Sales of Leqembi, Zurzuvae and Skyclarys contributed to Biogen’s sales and earnings guidance raise, positioning the company closer to potential growth.

Amvuttra Makes Strong ATTR-CM Showing As Alnylam Prepares For Global Launches

 
• By Alaric DeArment

In an interview, chief commercial officer Tolga Tanguler gave some ideas of what to expect as the company prepares to launch the drug for ATTR-CM in Europe.

Argenx Powers Ahead With Vyvgart’s Prefilled Syringe Launch

 
• By Andrew McConaghie

The Netherlands-headquartered company is enjoying huge success with Vyvgart in two autoimmune conditions, with a new prefilled syringe version reaching more patient groups.