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Thalidomide: 1961 Germany Withdrawn because of risk of teratogenicity; [62] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules Thenalidine: 1963 Canada, UK, US Neutropenia [3] [63] Thiobutabarbitone: 1993 Germany Kidney injury. [3] Thioridazine (Melleril) 2005 Germany, UK
Feet of a baby born to a mother who had taken thalidomide while pregnant. In the late 1950s and early 1960s, the use of thalidomide in 46 countries was prescribed to women who were pregnant or who subsequently became pregnant, and consequently resulted in the "biggest anthropogenic medical disaster ever," with more than 10,000 children born with a range of severe deformities, such as ...
Thalidomide, sold under the brand names Contergan and Thalomid among others, is an oral medication used to treat a number of cancers (e.g., multiple myeloma), graft-versus-host disease, and many skin disorders (e.g., complications of leprosy such as skin lesions).
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
The problem began in 2012, when the process for making tetrazole, a chemical intermediate in the production of various angiotensin II inhibitor medications for hypertension (popularly known by their common drug name suffix "sartan") was changed by generic drug manufacturers in favor of several cheaper and more efficient processes.
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
Frances Kathleen Oldham Kelsey CM (née Oldham; July 24, 1914 – August 7, 2015) was a Canadian-American [1] pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. [2]
A category for drugs withdrawn from the market after marketing commenced for any reason (voluntarily or involuntarily). For drug candidates that were abandoned prior to being marketed due to side effects, lack of efficacy, superior competitors, or other reasons, see Category:Abandoned drugs