PHARMACISTS should be aware that a large post-marketing rheumatoid arthritis safety study of the JAK inhibitor tofacitinib (Oral Surveillance Study), found an increased risk of major cardiovascular problems, such as heart attack and stroke, cancer, blood clots, serious infections and death, as compared with tumour necrosis factor inhibitors, the TGA has reported.
Based on the results of this study, a class-wide boxed warning, along with strengthened precautions about these risks have been added to the Australian Product Information documents for JAK inhibitors used to treat chronic inflammatory conditions, such as baricitinib, tofacitinib and upadacitinib, stated the TGA.
To minimise the risk of these side effects, JAK inhibitors should not be prescribed for chronic inflammatory conditions in people with a history of cardiovascular disease, nor to those at increased risk of cardiovascular problems such as current or past long-time smokers, and those at increased risk of cancer aged 65 years and over, unless there are no suitable alternative treatments, the TGA said.
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