Less than one month ago, Merck, a major U.S. pharmaceutical company, announced that its cholesterol drug Tredaptive failed a major clinical trial. The drug is meant to improve heart health by increasing levels of “good” cholesterol, but the trial found that patients on the drug did not have a reduced risk of heart attack, stroke, necessary bypass surgery, or death, and were actually found to have an increased risk for serious, though non-fatal, side-effects.
Merck announced this week that it is suspending the availability of Tredaptive worldwide. The decision is in line with a recommendation from the European medicine Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). The company has recommended that doctors stop prescribing Tredaptive and discontinue treatment with the drug for patients currently taking it. Merck is contacting regulatory agencies in countries where the drug is available, working with them to contact health care providers and pull Tredaptive.
“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 Dr. Michael Rosenblatt, Chief Medical Officer at Merck.
Tredaptive is approved in around 70 countries, and is available in around 40 countries, including many in Europe. Its trade names include Pelzont, Trevaclyn, and Cordaptive. Merck sold $13 million worth of Tredaptive in the first three quarters of 2012.