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The Food and Drug Administration (FDA) has placed a new black box warning on Arava (leflunomide), a drug used to treat rheumatoid arthritis, because it can increase the risk of severe liver injury. The drug’s current Boxed Warning states that lefluonmide is contraindicated in pregnant women, or women of childbearing potential who were not using reliable contraception, because the drug could harm the fetus.
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.
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