The Misperception That Clinical Trial Data Reflect Long-term Drug Safety: Lessons Learned From Efalizumab's Withdrawal

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

doi:10.1001/archdermatol.2009.188

Evidence-Based Dermatology: Research Commentary

September 2009

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; et al Robert S. Stern, MD

Author Affiliations Article Information

MICHAELBIGBYMD

OLIVIERCHOSIDOWMD, PhDROSAMARIACORONADSc, MDROBERT P.DELLAVALLEMD, PhD, MSPHURBÀ GONZÁLEZMD, PhDCATALIN M.POPESCUMD, PhDABRAR A.QURESHIMD, MPHHYWELWILLIAMSMSc, PhD, FRCP

Arch Dermatol. 2009;145(9):1037-1039. doi:10.1001/archdermatol.2009.188

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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

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The Misperception That Clinical Trial Data Reflect Long-term Drug Safety: Lessons Learned From Efalizumab's Withdrawal

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