The utilization of new and powerful drugs can cause unanticipated adverse reactions to patients due to the unique composition of each person and the other medical treatments they may be receiving, says Alabama liability attorney Keith T. Belt
A Novartis medicine (Ilaris) reduced pain from gout and juvenile rheumatoid arthritis, but also appeared to raise the chances of serious infections and other problems, U.S. drug reviewers said. Food and Drug Administration staff, in documents released on Friday, said determining whether the benefits of Ilaris outweighed risks was “complicated” in part because the product has extended effects in the body that are not typical of an acute treatment. The impact of just a single injection may be “protracted.”
Gout is a type of arthritis that occurs when uric acid builds up in the joints and about 8.3 million U.S. adults have gout suffer from this condition. Typically one or a few joints are affected such as the big toe or ankle. , Novartis said. FDA reviewers, in a preliminary analysis, said two studies showed Ilaris decreased pain more than an older drug, triamcinolone, reducing the risk of a new flare of pain.
However the drug also was linked to twice as many potential side effects that were considered serious. The rate was 7 percent for Ilaris compared with 3 percent for the other medicine. Serious infections were seen in 2 percent of Ilaris patients and none with the comparison drug. Ilaris also appeared to be associated with an increase in a number of findings, which together, could ultimately result in a negative impact in patients including reduced kidney function.
Given that Ilaris is expected to provide primarily a symptomatic benefit, is the risk of infection still outweighed by the clinical benefits? asked FDA reviewers in a memo.