FDA advises of serious adverse event with psoriasis biologic.
The
(2/20, B3, Whalen, Dooren) reports that on Feb. 19, the Food and Drug Administration (FDA) "warned that use of the" psoriasis drug Raptiva [efalizumab] "poses the risk of developing a rare and often fatal brain infection known as progressive multifocal leukoencephalopathy" (PML).
The
The
(2/20, Perrone) points out that, according to the FDA, "three patients taking" Raptiva "are believed to have died of" PML, "a known risk with the skin-clearing treatment." On Thursday, the agency "confirmed three cases and a possible fourth of" PML, "which causes swelling of the brain and is usually fatal. All the cases were reported in the last six months." Notably, "the FDA
came the same day that" the European Medicines Agency "recommended a ban on marketing the drug," which is "marketed in Europe by Swiss drugmaker Merck Serono."
"The FDA added a boxed warning, its strictest form of caution, to the prescribing information for Raptiva in October,"
"The FDA added a boxed warning, its strictest form of caution, to the prescribing information for Raptiva in October,"
(2/20, Olmos, Larkin) added. "The agency said it's reviewing the new information and 'will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits.'" Meanwhile, "Genentech is 'working diligently with the FDA to put the right plans in place that will help protect patient safety,' said Tara Cooper, a spokeswoman for Genentech, in an email statement." Genentech "is 'evaluating all possible approaches to address the risk of PML with Raptiva use, including a risk minimization plan.'"
Writing in the
Writing in the
(2/19) Health Blog, Jacob Goldstein observed, "PML is the same disease that has been linked to the multiple sclerosis drug Tysabri [natalizumab], sold by Biogen Idec and Elan." The condition is "caused by a typically harmless virus that almost everybody carries (often referred to as JC virus). In patients' whose immune system is weakened, the virus can attack the myelin, or white matter, that surrounds and protects brain cells. Both Tysabri and Raptiva affect the immune system."
In the
In the
(2/19) Booster Shots blog, Melissa Healy wrote, "All four patients had been taking" Raptiva, "for more than three years." In its "presentation prepared for FDA in 2003, Genentech reported that 'ongoing therapy with Raptiva provides extended benefit, with no increase in adverse events as exposure is prolonged.' That is a claim that the FDA will likely explore, given that those patients who succumbed to" PML "had been on the medication for at least three years."
According to the
According to the
(2/20, Leuty), "Raptiva was approved in October 2003 to treat chronic moderate to severe plaque psoriasis." At the time the drug was approved, "Raptiva treated 2,764 patients...but only 218 for more than one year." Among those patients, "there were no cases of PML at the time of its approval."
(2/19, Gardner) noted, "In its advisory, the FDA said it...'strongly recommends that healthcare professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment.'" The advisory suggested that "patients should be aware of the symptoms of PML and contact their healthcare professionals immediately if they experience any such symptoms." Still, "outside experts" emphasized that, "though the news was serious, there was no reason to panic." Bruce Bebo, Jr., of the National Psoriasis Foundation, urged patients to consult with their physicians and "carefully weigh the risks and benefits of Raptiva."
(2/19, Hitti) reports that symptoms of PML "may include unusual weakness, loss of coordination, changes in vision, difficulty speaking, and personality changes."
"Last October, the FDA required Genentech to add boxed warning to highlight the risk of life-threatening infections, notably PML, but also including bacterial sepsis, viral meningitis, and invasive fungal disease,"
"Last October, the FDA required Genentech to add boxed warning to highlight the risk of life-threatening infections, notably PML, but also including bacterial sepsis, viral meningitis, and invasive fungal disease,"
(2/19, Fiore) explained. The
(2/20, Burke-Kennedy) and
/Modern Medicine (2/19) also covered the story.
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