US drug manufacturer Merck announced it is withdrawing the cholesterol drug Tredaptive from sales in 40 countries after the European Medicine Agency (EMA) found out the drug doesn’t work and can trigger serious side effects.
The decision to suspend availability of the medicine is aligned with the recommendation of the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) based on the trial’s results.
In countries where the medicine is currently available, Merck has begun informing regulatory agencies of the company’s decision. Merck is working with these agencies to develop communications for health care providers and to suspend the availability of TREDAPTIVE, with the timing to be based on individual country regulations and processes.
Merck is recommending that physicians stop prescribing TREDAPTIVE. Merck is also recommending that physicians review treatment plans for patients taking TREDAPTIVE in a timely manner to discontinue TREDAPTIVE and consider other changes in therapy to achieve their dyslipidemia management goals. In the meantime, Merck encourages patients with questions to speak with their health care provider, and to not discontinue therapy without first speaking with their physician.
“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,” said Michael Rosenblatt, M.D., Chief Medical Officer, Merck.