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Why was Duract approved in the first place? Why wasn’t this problem picked up during the trials of the drug prior to approval?

April 26, 2017Approval Approved drug duract prior problem trials

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Why was Duract approved in the first place? Why wasn’t this problem picked up during the trials of the drug prior to approval?

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While there are many pain relievers, there is still a need for good medicines, and Duract was very effective in relieving pain. The safety profile of Duract was acceptable in testing before approval. No cases of serious liver injury were reported in pre-marketing clinical trials. There were some cases of liver enzyme elevations in patients treated for 30 days or longer, but these elevations resolved with discontinuation of therapy and patients did not experience any problems.