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USFDA adds strict safety warnings on Pfizer, AbbVie, Lilly arthritis drugs

ruchikaBy ruchika  |  
USFDA adds strict safety warnings on Pfizer, AbbVie, Lilly arthritis drugs

New Delhi: 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 on the labels follows the agency's review of Pfizer's Xeljanz...

New Delhi: 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 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.

Read also: Johnson & Johnson COVID-19 vaccine may lead to Guillain-Barre syndrome, FDA to issue warning

pfizer eli lilly usfda abbvie arthritis drug xeljanz cancer 
ruchika
ruchika

    Ruchika joined Medical Dialogue an Desk Editor for the Business Section in 2019. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate from Delhi University. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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