European Union Regulators, On Same Day, Recommend That Raptiva Be Withdrawn Because Its Risks Outweigh The Benefits
Update: April 2009: Raptiva Recall In U.S.
On April 8, 2009 we learned that Raptiva has been recalled due to the association between Raptiva and progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.
More information about this Raptiva recall can be found in the Genentch press release and the FDA statement:
We provide the history of Raptiva in a basic timeline that is part of our April 9, 2009 article about the Raptiva recall. (4/9/09)
(Posted by Tom Lamb at DrugInjuryWatch.com)
On February 19, 2009 the FDA confirmed that Raptiva (efalizumab) had been linked to three cases of progressive multifocal leukoencephalopathy (PML), a rare brain infection which causes swelling of the brain and is usually fatal. The FDA said that all the cases were reported in the last six months.
That same day, across the Atlantic, the European Medicines Agency announced it had completed its safety review of Raptiva and said the Agency’s Committee for Medicinal Products for Human Use (CHMP) had concluded that the benefits of Raptiva do not outweigh its risks. Accordingly, they recommended that the use of Raptiva should be suspended across the European Union.
Raptiva was approved by the FDA in 2003 to treat adults with moderate to severe chronic plaque psoriasis.
From the February 19 MedWatch Alert email concerning this association between Raptiva and PML:
FDA issued a Public Health Advisory to notify healthcare professionals of three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva. In October 2008, the labeling for Raptiva was changed to highlight, in a Boxed Warning, the risks of life-threatening infections, including PML. In addition, FDA directed Genentech, the manufacturer of Raptiva, to develop a Risk Evaluation and Mitigation Strategy, or REMS, to ensure that patients receive risk information about Raptiva. The FDA is reviewing this latest information. The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health care professionals carefully monitor patients for the possible development of PML. The Public Health Advisory provides recommendations for healthcare. [hyperlink added]
For comparison purposes, one might want to read the European Medicine Agency’s document, "Efalizumab (Raptiva): Recommendation to suspend marketing authorisation as risks outweigh benefits". The essence of their position can be taken from this excerpt:
Although psoriasis is a disabling condition that can cause social and psychological problems for patients, it is very rarely life-threatening. The Committee concluded that the risk of PML is unacceptable for patients taking efalizumab. They recommended that the marketing authorisation should be suspended until there is adequate new evidence to identify a group of patients in which the benefits of efalizumab outweigh its risks.
From a February 19 AP article, "FDA says 3 deaths associated with Genentech drug", we get the drug company reaction to what is happening to Raptiva in the U.S.:
"We take the risk of PML very seriously and are working diligently with the FDA to put the right plans in place that will help protect patient safety," said company spokeswoman Tara Cooper.
We will wait to see if the FDA decides to follow the lead taken by its European Union counterparts and eventually issue a Raptiva recall order, here.
P.S. At the recommendation of Health Canada, EMD Serono Canada Inc. has suspended the marketing of Raptiva in Canada due to safety concerns, including the increased risk of developing PML. (2/21/09)