Doctors were told to stop giving prescriptions for an anti-cholesterol medication because it does not work and can trigger a number of side effects. The drug watchdog in Europe suspended Tredaptive yesterday over safety concerns.
Close to 3,000 Britons who have levels of cholesterol that are high have been prescribed the medication, usually as an addition to the standard statins that lower cholesterol.
Merck, the U.S. manufacturer of the drug announced it would withdraw Tredaptive from pharmacies in more than 40 countries. The drug is not sold in the U.S.
EMA, the European Medicine Agency said it completed a review of new data that was gained from a recently complete long term, large scale study of over more than 25,000 patients. The data cast doubt on the benefits of the medication.
Preliminary results showed that adding the drug to statins did not lower the risk of suffering a heart attack or stroke compared to use of statins alone. The study also found a great rate of serious side effects that were not fatal but included muscle weakness, bleeding, diabetes and infections.
The agency concluded that the medicine gave no significant benefit that was additional to statins for patients who had a high risk of cardiovascular disease.
Even though Tredaptive reduced the levels of triglyceride fat effectively and also increased the “good” HDL cholesterol, the study did not prove that this benefited the patients.
The medication has been approved in the UK and other EU countries for four years. It is used in combination with statins and could be used by itself only if patients could not take statins.
Late this month the agency will make a final decision on the drug.