January 12, 2013
Merck To Suspend Sale Of Cholesterol Drug Tredaptive
redOrbit Staff & Wire Reports — Your Universe Online
New Jersey-based pharmaceutical company Merck is telling doctors to stop prescribing the cholesterol drug Tredaptive following a study that casts doubt on the medication´s efficacy and safety.Tredaptive, which has not yet been approved in the US, is currently sold in more than three dozen countries worldwide, according to the Associated Press. In addition to putting a halt to prescriptions, Merck is also advising patients to stop using the extended-release niacin/laropiprant tablets.
The decision comes in the wake of results from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study that showed adding the new medication to traditional statin treatment “failed to lower the risk of heart attack, stroke and related problems,” the wire service reported. The firm said it will take a few months to fully implement the suspension order.
Before the decision to cease use of Tredaptive entirely, the pharmaceutical company sent a letter to doctors in several European nations where it had been available, according to Forbes staff writer Matthew Herper. In that letter, Merck said the side effects had been discovered in seven “broad categories” — blood and lymphatic; gastrointestinal; infections; metabolism; musculoskeletal; respiratory; and skin.
“Despite the fact that Tredaptive had not shown a benefit, the recommendation at that time was that patients should not start the drug but that those who were taking it did not need to stop,” Herper said. “That recommendation, obviously, is changing, as Merck is working with regulators around the world to stop the sale of the medicine.”
In a statement released Friday, Merck said the HPS2-THRIVE study revealed Tredaptive had not achieved “its primary endpoint of reduction of major vascular events,” and that there was “a statistically significant increase in the incidence of some types of non-fatal serious adverse events” among participants who had added the medication to their regular statin therapy.
The decision was also reached in part because of recommendations made by the European Medicine Agency´s Pharmacovigilance Risk Assessment Committee in the wake of the trial´s results.
“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,” Merck´s Chief Medical Officer, Dr. Michael Rosenblatt, said in a statement.