Jan 11 U.S. drugmaker Merck & Co said it is
taking steps to suspend availability of its drug Tredaptive
after the medicine, used to raise "good" HDL cholesterol, failed
to prevent heart problems in a large study.
The medicine is not approved in the United States but is
sold in about 40 countries.
Merck said it is recommending that doctors stop
prescribing Tredaptive, based on negative findings from the
trial which were announced last month. The study followed more
than 25,000 patients in Europe and China for almost four years.
The company said it will encourage doctors to consider
alternative treatments to control their cholesterol, but advised
patients not to discontinue Tredaptive without first speaking
with their physicians.
Merck did not say, in its press release, when it plans to
halt shipments of Tredaptive.
Tredaptive combines an extended-release form of niacin with
another drug meant to reduce facial flushing, a side effect of
niacin. The medicine has annual sales of less than $20 million.
That makes it a tiny product for Merck, which has global annual
revenue of about $50 billion.
Merck in December said Tredaptive did no better in the study
at preventing heart attacks, deaths or strokes than traditional
statin drugs that lower "bad" LDL cholesterol.
Moreover, Merck said the medicine significantly raised the
incidence of some types of nonfatal but serious side effects in
the study. They included blood, lymph and gastrointestinal
problems, as well as respiratory and skin issues.
Tredaptive was approved in the European Union in 2008, but
the U.S. Food and Drug Administration was unwilling to approve
the pill until Merck conducted the costly long-term study to
better assess its safety and effectiveness.
Some analysts had expected Tredaptive to capture annual
global sales of more than $1 billion, if it were to win approval
in the United States.