January 11th, 2013
Merck Starts to Suspend Worldwide Availability of Tredaptive
In the wake of the negative HPS2-THRIVE study announced last month, Merck said today that it was beginning to suspend the worldwide availability of Tredaptive, its combination of extended-release niacin and laropiprant.
Merck described its decision as being “aligned” with that of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), which recommended on Thursday that drugs containing extended-release niacin and laropiprant should be suspended. The drug is not available in the United States. In some countries the drug combination is known as Pelzont, Trevaclyn, or Cordaptive.
Merck said it was working with regulatory 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 said that it is “recommending that physicians stop prescribing” the drug and that physicians begin to “review treatment plans for patients taking Tredaptive in a timely manner to discontinue” the drug.
In December Merck announced that HPS2-THRIVE had not reached its primary endpoint but that treatment with the combination pill had resulted in a statistically significant increase in some nonfatal serious adverse events. Merck said that preliminary analyses “suggest that the adverse events fall within the following broad categories: blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin.”