The psoriasis drug Raptiva will get some new labeling changes, announced the FDA. Raptiva’s new label will include a Boxed Warning highlighting the risks of life-threatening infections. Raptiva is administered as an injection to treat moderate to severe plaque psoriasis in adults. It is not approved for children under 18. Some of the infections included in the new Boxed Warning are bacterial sepsis, viral meningitis, invasive fungal disease and progressive multifocal leukoencephalopathy (PML). The FDA’s post-market surveillance of Raptiva led to the label changes. Because Raptiva works to suppress the immune system, it can increase the risk of serious infections. Doctors should closely monitor their patients who are using Raptiva and should educate the patients about the signs and symptoms of adverse effects of Raptiva.
The Legal Examiner and our Affiliate Network strive to be the place you look to for news, context, and more, wherever your life intersects with the law.
Comments for this article are closed.