A drug has been approved in the US for moderate to severe rheumatoid arthritis by the Food and Drug Administration (FDA).
The FDA approved Actemra (tocilizumab), the use of which is limited to patients who fail other approved therapies because of serious safety concerns noted in clinical studies.
These include elevated liver enzymes, elevated LDL or bad cholesterol, hypertension, and gastrointestinal perforations.
But the administration said it requires the sponsor to conduct a post-marketing clinical trial to further evaluate the long-term safety of the drug.
It wants to evaluate the impact of elevated LDL cholesterol and blood pressure seen in some patients in shorter-term trials on the cardiovascular health of patients treated with Actemra.
Physicians and patients alike need to be aware of the risk of serious adverse effects of Actemra, said Bob Rappaport, MD, who is a member of the FDA.
Both parties need to be able to make informed decisions regarding the benefits and risks of the drug in the treatment of individual patients, added Dr Rappaport.
The researcher is the director of the Division of Analgesics, Anesthetics and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
Copyright Press Association 2010