Abstract
PERSPECTIVESThalidomide was banned worldwide in the 1960s due to its teratogenicity, and remained so until the late 1990s when it returned to physicians’ armamentarium as a medicine for a variety of inflammatory diseases and hematological ma-lignancies that were difficult to treat. A landmark event in this resurgence was the discovery that thalidomide inhibited angiogenesis in the rabbit cornea micropocket assay (1994) and the subse-quent successful clinical testing in patients with advanced multiple myeloma
Highlights
In 1994, an active search undertaken by nongovernmental organizations (NGOs) brought to light a number of cases of thalidomide embryopathy born after 1965 that had remained almost unnoticed for nearly three decades 1
Notwithstanding the foregoing stringent regulations, at least five more cases of thalidomide embryopathy were diagnosed in babies born between 2005 and 2010 1
Lenalidomide was the first thalidomide-like drug that received a clearance for sales in the US, Europe (2013) and in other countries
Summary
In 1994, an active search undertaken by nongovernmental organizations (NGOs) brought to light a number of cases of thalidomide embryopathy born after 1965 that had remained almost unnoticed for nearly three decades 1. Thalidomide first entered the US pharmaceutical market in 1998 when Celgene Co. received US Food and Drug Administration (FDA) clearance to sell Thalidomid for manifestations of ENL, a morbid condition almost inexistent in the country. The European Medicines Agency (EMA) designated Thalidomide-Celgene (in indications for multiple myeloma) an “orphan medicine” (November 2001) because of the low prevalence of the disease in the EU (1.2 per 10,000 people).
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