Search results
Results From The WOW.Com Content Network
Thalidomide: 1961 Germany Withdrawn because of risk of teratogenicity; [62] returned to market for use in leprosy and multiple myeloma under FDA orphan drug rules Thenalidine: 1963 Canada, UK, US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
Thalidomide brought on changes in the way drugs are tested, what type of drugs are used during pregnancy, and increased the awareness of potential side effects of drugs. According to Canadian news magazine programme W5 , most, but not all, victims of thalidomide receive annual benefits as compensation from the Government of Canada .
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]
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).
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.
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.
The thalidomide molecule is a synthetic derivative of glutamic acid and consists of a glutarimide ring and a phthaloyl ring (Figure 5). [15] [16] Its IUPAC name is 2-(2,6-dioxopiperidin-3-yl)isoindole-1,3-dione and it has one chiral center [15] After thalidomide's selective inhibition of TNF-α had been reported, a renewed effort was put in thalidomide's clinical development.
Generic drug manufacturers often change the way in which prescription drug ingredients are made in order to lower costs of making them, so this kind of contamination may be more widespread and undetected in generic drugs. [21] 2022–2023 United States P. aeruginosa outbreak in eye drops