A cholesterol drug by the name of Tredaptive is being recalled from the global market by its manufacturer.
Merck & Co, a United States drug manufacturer, is halting distribution of the cholesterol medication from all overseas markets where it is currently sold. While Tredaptive failed to gain domestic approval by the United States Food and Drug Administration, the medication has been available in approximately 40 other countries.
An article by Reuters reports that the recall comes on the heels of a large study which raised issue with the drug’s effectiveness at preventing heart problems. The study, titled HPS2-Thrive, also revealed several safety risks connected with the medication’s use.
Tredaptive was intended to raise “good” HDL cholesterol levels in patients while reducing negative side effects typically associated with this type of cholesterol treatment such as facial flushing. However, a recent study concluded that Tredaptive was no more effective at the prevention of heart attacks, stroke, or death than traditional cholesterol medications.
The study, which followed approximately 25,000 patients in Europe and China over a four year span of time, also found Tredaptive users to have a significant increase in some forms of nonfatal but serious side effects. The negative effects ranged from respiratory and skin problems to blood, gastrointestinal, and lymph issues.
According to The Wall Street Journal, following the results of the HPS2-Thrive study late last year, Merck announced that it would not continue to seek approval from the United States Food and Drug Administration. The global recall announcement follows a recommendation by advisers to the European Medicines Agency, which believes the cholesterol drug’s risks outweigh its medical benefits.
At this time, Merck is recommending that overseas physicians cease prescribing Tredaptive for patients and urges current users of the cholesterol drug to consult with their doctor about possible treatment plans. Michael Rosenblatt, Merck’s chief medical officer, said in a press release:
“Patients currently taking Tredaptive are our priority, and we are committed to continue to work with regulatory agencies around the world to ensure that physicians have appropriate information as we take steps to suspend the availability of Tredaptive.”
What are your thoughts on the cholesterol drug Tredaptive being recalled from the global market?