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Still used as veterinary drug and as a human antihelminthic in many markets; listed on the WHO List of Essential Medicines. In humans, it was used to treat melanoma before it was withdrawn for agranulocytosis. [29] [30] [31] Levomethadyl acetate: 2003 US Cardiac arrhythmias and cardiac arrest. [2] Lorcaserin (Belviq) 2020 US Increased risk of ...
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 ...
The FDA required that Celgene Corporation, which planned to market thalidomide under the brand name Thalomid, establish a system for thalidomide education and prescribing safety (STEPS) oversight program. The conditions required under the program include limiting prescription and dispensing rights to authorized prescribers and pharmacies only ...
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 following list encompasses notable medicine contamination and adulteration incidents. 1937 Elixir sulfanilamide incident: S. E. Massengill Company used diethylene glycol as the solvent for the antibacterial sulfanilamide , leading to the 1938 passage of the Federal Food, Drug, and Cosmetic Act .
A category for drugs withdrawn from the market after marketing commenced for any reason (voluntarily or involuntarily).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
Grünenthal provided thalidomide to more than 1,000 patients with leprosy in the United States until a few months before July, 1986. The drug is especially helpful to patients with leprosy in treating an extremely painful allergic reaction of the skin. The company discontinued exporting thalidomide because of liability fears.
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.