FDA adds strict safety warnings to arthritis medications

 The U.S. health regulator added its strictest warning to labels of drugs from Pfizer (PFE.N), Eli Lilly (LLY.N) and AbbVie (ABBV.N) belonging to a class of anti-inflammatory treatments called JAK inhibitors, which cite the risk of serious health issues and death in patients 50 and older, drugmakers said Friday.

The addition of the warning to labels follows Pfizer’s agency review of Xeljanz after initial results from a trial in February showed an increased risk of serious heart -related problems and cancer in some patients who treated with medicine. read more

Xeljanz, which brought in global sales of $ 2.44 billion for Pfizer in 2020, has been 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 drugs Rinvoq and Pfizer’s Xeljanz are now recommended for use only in patients, who have had an inadequate response or intolerance to one or more TNF blockers, which is another class of drugs used against in inflammatory conditions.

The Food and Drug Administration’s boxed warnings on the labels of Rinvoq, Xeljanz and Lilly’s Olumiant flag the risk of cardiovascular death and stroke in high-risk patients age 50 and older, and currently or a former smoker.

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

Marketing applications for the extended use of Rinvoq in atopic dermatitis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis remain under review by the FDA, AbbVie said.

https://newsfounded.com/ethiopia/fda-adds-strict-safety-warnings-to-arthritis-medications-from-pfizer-abbvie-and-lilly/