Tredaptive, a cholesterol drug manufactured by Merck & Co is being recalled from the global market by its manufacturer. The United States drug manufacturer is halting distribution of Tredaptive from approximately 40 other countries where it is currently being sold.
The recall stems from a large study which raised issue with the drug’s effectiveness at preventing heart problems. The study is titled HPS2-Thrive. HPS2-Thrive revealed several safety risks connected with the medication’s use.
The study followed approximately 25,000 patients in Europe and China over a four year span of time. It found Tredaptive users to have a significant increase in some forms of negative serious side effects ranging from respiratory and skin problems to blood, gastrointestinal, and lymph issues. Following the results of the HPS2-Thrive study late last year, Merck announced that it would not continue to seek approval from the US Food and Drug Administration. Because of this decision, Tredaptive is not available in the US.
The worldwide recall announcement follows a recommendation by advisers to the European Medicines Agency. The agency believes the cholesterol drug’s risks outweigh its medical benefits. Merck is currently recommending that overseas physicians cease prescribing Tredaptive for patients.
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