In , the FDA approved thalidomide to treat leprosy under limited conditions. With many medical subdisciplines requesting permission to test and use thalidomide, the FDA formed a Thalidomide Working Group in to develop consent forms and patient information brochures.
In , the FDA met with pharmaceutical companies that wanted to apply for approval to market thalidomide. Biomedical researchers wanted to test thalidomide's efficacy in clinical trials on conditions such as AIDS wasting syndrome.
This program required registration by physicians who prescribed thalidomide, as well as their patients. The program also insisted on a number of contraceptive measures such as proof of an initial negative pregnancy test prior to treatment, proof that the patient was using two forms of contraception , and submission of monthly pregnancy tests. The FDA placed Thalidomide under Category X of the FDA's pregnancy ratings, categories created in for pharmaceutical companies to label medications according to their affects on reproduction.
The fifth and most severe rating, Category X, is for drugs that empirically contribute to fetal deformities, and for drugs whose risks or undesired effects outweigh possible benefits to the patient. This pregnancy rating and the STEPS program later served as a foundation for the FDA's response to isotretinoin Accutane , a prescription drug used to treat severe acne. Like thalidomide, isotretinoin caused severe birth defects and prompted its manufacturer and the FDA to create a risk management program to prevent fetal exposure.
In July , the FDA approved the marketing of thalidomide, and today the drug is used to treat inflammation associated with leprosy and also acts as a chemotherapeutic agent for patients with cancer of the plasma cells in bone marrow multiple myeloma. While thalidomide prompted the US government to extend the powers of the FDA with respect to drug approval and monitoring powers, amendments subsequent to those in have further extended the FDA's system of regulation. In amendments to the Medical Device Regulation Act required medical device manufacturers to register with the FDA and follow quality control guidelines.
Similarly, the Nutrition Labeling and Education Act required all packaged foods to contain standardized nutritional information and standardized information on serving sizes. US Regulatory Response to Thalidomide Thalidomide, a drug capable of causing fetal abnormalities teratogen , has caused greater than ten thousand birth defects worldwide since its introduction to the market as a pharmaceutical agent. Sources Annas, George J. Blauberman, Scott. InstRepos Accessed October 22, Drug Efficacy Amendment of Federal Food, Drug, and Cosmetics Act of Fintel, Bara, Anthena T.
Samaras, and Edson Carias. Franks, Michael E. Macpherson, and William D. Law, Marc. It was marketed in 50 countries before being withdrawn in due to malformations in newborns. Be careful with what is coming.
There are different approval processes for the coronavirus vaccines and the drug thalidomide. Thalidomide was not approved for sale in the U. The drug did not undergo extensive trials as is being done with COVID vaccines currently being developed. Pfizer and Moderna recently announced that clinical trials showed their vaccines were more than 90 percent effective. When the coronavirus was declared a global pandemic in March, medical professionals predicted that developing a vaccine to combat COVID could take 18 months or more.
Posts online are comparing the short time period in which COVID vaccines have been developed with issues around thalidomide, a drug that was once banned worldwide for causing birth defects in babies. Kelsey reviewed applications for new drugs, which was a legal requirement to demonstrate safety by drug manufacturers before they went on the market.
At the time, the FDA had a day period to reject the application here. Thalidomide, developed by the German firm Gruenenthal, was withdrawn from the West German market on Nov. A Cincinnati company called William S. Merrell tried to bring thalidomide to the U. According to the University of Chicago Medicine here , Kelsey initially reacted to the thalidomide application filed by William S.
Kelsey saw a letter in the British Medical Journal in which a physician had reported cases of peripheral neuritis, which causes nerve damage in hands and feet, and requested proof from the Merrell company that the drug would not harm a fetus. William S. Check with your doctor before taking any other medications, including prescription medications and medications that are available without a prescription.
Researchers are working to create drugs that work like thalidomide but have fewer side effects. Drugs that are chemically similar to thalidomide are available, including:. Talk to your doctor if you have concerns about thalidomide. Understanding thalidomide's history, its risks and its potential benefits can help you decide if it's right for you.
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