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The FDA has issued a public health advisory regarding the risk of progressive multifocal leukoencephalopathy (PML) associated with use of efalizumab (Raptiva®) for the treatment of psoriasis. Four cases have been reported (3 have been confirmed). The FDA is recommending that health care professionals monitor patients on efalizumab, as well as those who have discontinued the drug, for signs and symptoms of neurologic disease.
The FDA has reaffirmed its position regarding cholesterol-lowering drugs stating that "elevated amounts of low-density lipoprotein … are a risk factor for cardiovascular diseases … and that lowering LDL cholesterol reduces the risk of these diseases." The statement is in response to results from the ENHANCE trial, which indicated that there was no significant difference between simvastatin plus ezetimibe (Vytorin®) vs simvastatin alone (Zocor®) in reducing carotid atherosclerosis. There was, however, a greater reduction in LDL in the Vytorin group vs the Zocor group (56% reduction vs 39% reduction, respectively). The statement from the FDA suggests that the results of ENHANCE do not change the FDA's position that greater LDL lowering is beneficial, and recommends that patients currently on Vytorin or other cholesterol-lowering medications should not change their therapy. The update is available on the FDA's web site at www.FDA.gov.