Log in
Show password
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Dynamic quotes 
News: Latest News
Latest NewsCompaniesMarketsEconomy & ForexCommoditiesInterest RatesBusiness LeadersFinance Pro.CalendarSectors 
All NewsEconomyCurrencies & ForexEconomic EventsCryptocurrenciesCybersecurityPress Releases

FDA adds strict safety warnings on arthritis drugs from Pfizer, AbbVie and Lilly

12/03/2021 | 04:52pm EST

Dec 3 (Reuters) - The U.S. health regulator has added its strictest warning to the labels of drugs from Pfizer, Eli Lilly and AbbVie belonging to a class of anti-inflammatory treatments called JAK inhibitors, citing risk of serious health issues and death in patients 50 and over, the drugmakers said on Friday.

The addition of the warning https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203214s031lbl.pdf on the labels follows the agency's review of Pfizer's Xeljanz after initial results from a February trial showed an increased risk of serious heart-related problems and cancer in some patients being treated with the drug.

Xeljanz, which brought in worldwide sales of $2.44 billion for Pfizer in 2020, is approved in the United States for the treatment of conditions including rheumatoid arthritis, psoriatic arthritis and ulcerative colitis - an inflammatory bowel disease.

AbbVie's rheumatoid arthritis drug Rinvoq and Pfizer's Xeljanz are now recommended for use only in patients, who have had inadequate response or intolerance to one or more TNF blockers, which are another class of drugs used against inflammatory conditions.

The Food and Drug Administration's boxed warnings on the labels of Rinvoq , Xeljanz and Lilly's Olumiant flags the risk of cardiovascular death and stroke in high-risk patients who are aged 50 and above, and are current or past smokers.

Additional information about the risk of some types of cancer and death was also added to their labels.

The marketing applications for Rinvoq's expanded use in atopic dermatitis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis remain under review by the FDA, AbbVie said. (Reporting by Manojna Maddipatla in Bengaluru; Editing by Anil D'Silva and Krishna Chandra Eluri)

ę Reuters 2021
Latest news "Economy & Forex"
04:04pRbnz- consultation has resulted a refined approach to developing legally binding standards for designated fmis
04:04pRbnz - changes include treatment of critical service providers & discretion regarding publication of material breaches
04:03pRbnz - finalised framework balances need for flexibility in accounting for specific circumstances of individual fmis
04:03pRbnz- rbnz & fma released their finalised framework for assessing systemic importance of financial market infrastructures
04:02pReserve bank of new zealand - reserve bank and fma finalise fmi regulatory framework
04:02pWall Street sell-off deepens, Nasdaq confirms correction
04:01pWall Street sell-off deepens, Nasdaq confirms correction
04:00pNasdaq confirms correction, ends 10.7% below record close reached on nov 19
03:53pU.S. to set 'common goals' on Indo-Pacific economic cooperation in early 2022
03:52p10-Year Treasury Yield Falls to 1.826% -- Data Talk
Latest news "Economy & Forex"