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Vol. 145 No. 9, September 2009 TABLE OF CONTENTS
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Evidence-Based Dermatology: Research Commentary
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The Misperception That Clinical Trial Data Reflect Long-term Drug Safety

Lessons Learned From Efalizumab's Withdrawal

Tamar Nijsten, MD, PhD; Phyllis I. Spuls, MD, PhD; Luigi Naldi, MD; Robert S. Stern, MD

Arch Dermatol. 2009;145(9):1037-1039.

Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

Commentary on: Press Release: European Medicines Agency recommends suspension of the marketing authorisation of Raptiva (efalizumab).
The European Medicines Agency
http://www.emea.europa.eu/humandocs/PDFs/EPAR/raptiva/2085709en.pdf

The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Raptiva (efalizumab), from Serono. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Raptiva no longer outweigh its risks, because of safety concerns, including the occurrence of progressive multifocal leukoencephalopathy (PML) in patients taking the medicine.1

On February 19, 2009, the European Medicines Agency (EMEA) and the Food and Drug Administration (FDA) issued statements about the safety concerns regarding the risk of progressive multifocal leukoencephalopathy (PML) with the use of efalizumab in patients with psoriasis.1-2 That day, the EMEA recommended suspending sales of efalizumab because of an altered risk to benefit ratio . . . [Full Text of this Article]

COMMENT


AUTHOR INFORMATION
 Department of Dermatology, Erasmus MC, Rotterdam, the Netherlands (Dr Nijsten); Department of Dermatology, Amsterdam Medical Centre, Amsterdam, the Netherlands (Dr Spuls); Centro Studi Gruppo Italiano Studi Epidemiologici in Dermatologia (GISED), Bergamo, Italy (Dr Naldi); and Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts



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THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Linking Publication About Efalizumab Effectiveness With Safety Concerns
Arch Dermatol 2009;145:1338-1338.
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