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Create a 6 page essay paper that discusses Oraflex Drug Death.In 1973 along with filing for patents for Oraflex in its original name Benoxaprofen, it also filed for sanction for testing the drug on hu
Create a 6 page essay paper that discusses Oraflex Drug Death.
In 1973 along with filing for patents for Oraflex in its original name Benoxaprofen, it also filed for sanction for testing the drug on humans with the Food and Drug Administration (FDA) of U.S.A, thus initiating the clinical testing procedure in the country. (2).
In 1980, after spending an estimated cost of $70 million resulting in a more than 100,000 pages test report and patient records Eli Lilly & Company approached FDA for sanction to market Oraflex in U.S.A. Eli Lilly on the basis of test reports claimed minimal side effects for Oraflex, essentially pertaining to enhanced sunlight sensitivity and other skin problems. No severe side effects were reported with Oraflex. Sanction was received to market Oraflex, and on May 1982 Oraflex was introduced into the American market. (2).
In the same month signs of severe problems with Oraflex emerged with a report in the British Medical Journal that British physicians believed that Oraflex had caused the death of twelve individuals through its side effects associated with kidney and liver failure in the country. Nearly three months ahead, on August 4, 1982, the Oraflex issue came to head, when the British Government on the basis of calls for removal of Oraflex from the market, suspended temporarily the marketing of Oraflex on the grounds of safety.