Assessing Long-Term Drug Safety: Lessons (Re) Learned from Raptiva
| Autor: | Nicole M. Seminara, Joel M. Gelfand |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Drug
medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions media_common.quotation_subject Efalizumab Dermatology Pharmacology Antibodies Monoclonal Humanized Article Pharmacovigilance Product Surveillance Postmarketing medicine Drug approval Humans Psoriasis In patient Intensive care medicine Drug Approval media_common business.industry Progressive multifocal leukoencephalopathy Moderate to severe psoriasis Antibodies Monoclonal medicine.disease Surgery business medicine.drug |
| Zdroj: | Seminars in Cutaneous Medicine and Surgery. 29:16-19 |
| ISSN: | 1085-5629 |
| DOI: | 10.1016/j.sder.2010.01.001 |
| Popis: | Efalizumab was approved for moderate to severe psoriasis in 2003 based on studies in approximately 2,700 patients of whom only 218 were exposed to the drug for more than one year. In 2009, after over 46,000 patients were exposed to efalizumab, the drug was withdrawn from the market after 3 confirmed and one suspected case of progressive multifocal leukoencephalopathy (PML) were spontaneously reported. As PML is very rare, it is extremely unlikely that the four reported cases were due to chance and given that PML occurs primarily in patients who are immunosuppressed, the association is likely causal. The identification of PML as a serious, but statistically rare risk of efalizumab demonstrates the strengths and weaknesses of the current drug approval and pharmacovigilance processes for fully measuring the safety of a drug. Patients and clinicians need to be aware of the relative completeness and limitations of existing safety data of a drug when selecting a treatment. |
| Databáze: | OpenAIRE |
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