Makers of Oluminant Withdraw Lupus Treatment Approval Request in Face of JAK-Inhibitor Health Risks
The manufacturer also expects the FDA to reject approval for the drug for the treatment of atopic dermatitis due to FDA safety cocerns.
The manufacturer also expects the FDA to reject approval for the drug for the treatment of atopic dermatitis due to FDA safety cocerns.
In addition to heart problems and cancers, researchers also saw an increased risk of opportunistic infections, like shingles.
The move comes after the FDA held up Rinvoq approvals for months due to concerns it carried similar cancer and heart risks as Xeljanz.
The approvals come after new warnings about Xeljanz and Rinvoq side effects, which have been linked to cancer, blood clots and heart problems.
Cancer and heart risks linked to Rinvoq, Xeljanz and similar drugs have regulated them to secondary treatment options for rheumatoid arthritis.
Study claims heart risks with Olumiant are the same as those of rheumatoid arthritis patients not taking the drug, raising questions about a class-wide warning after concerns about the side effects of Xeljanz emerged
More research is needed into the link between Xeljanz and heart problems to determine how much of the risk is caused by side effects of the drugs, or the condition they are designed to treat, the researchers note
The issues come as similar drugs, like Xeljanz, face intense scrutiny over heart problems and cancer risks.