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RA 2 articles

FDA panel considers benefits, risks of experimental rheumatoid arthritis drug

Drug regulators are questioning whether an experimental drug for rheumatoid arthritis has too great of a cancer risk and whether it actually works as well as the drug company claims. The drug, tofacitinib, marketed by Pfizer, is under review by a Food and Drug Administration (FDA) advisory panel, which will vote whether to recommend the treatment for FDA approval. The FDA isn’t required to follow the advice of its expert panels, but it usually does. Analysts have pegged tofacitinib as a potential blockbuster medication. “Blockbuster drugs” are ones that generate at least $1 billion in revenue for their owner over ... Read More

Rheumatoid Arthritis drug linked to serious neurological disorder

The Food and Drug Administration (FDA) has received a third case of a serious and often fatal neurological disorder known as progressive multifocal leukoencephalopathy (PML) in a patient with rheumatoid arthritis (RA) treated with the drug Rituxan (rituximab). The report has led the agency to inform rheumatological health care professionals that patients with RA who have received Rituxan are at an increased risk of PML. Physicians should consider the risks in any patient treated with Rituxan who presents new onset neurological manifestations. The FDA advises consultation with a neurologist, brain MRI, and lumbar puncture should be considered as clinically indicated. ... Read More