* Merck says recalling drug from wholesalers
* Says retail supplies likely available until mid-March
* Says will discourage doctors from prescribing drug
Jan 11 Merck & Co said it is recalling
Tredaptive, its medicine to raise "good" HDL cholesterol levels,
in overseas markets where it is sold, after it failed to prevent
heart problems in a large study and raised safety concerns.
The medicine is not approved in the United States but the
U.S. drugmaker sells it in about 40 countries.
Merck said it would recall stocks of Tredaptive now
held by wholesalers, but that pharmacies can continue to
dispense their remaining supplies. Even so, the company said it
plans to discourage doctors from prescribing the pill 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 cholesterol, but advised
patients not to discontinue Tredaptive without first speaking
with their physicians.
Merck spokeswoman Pam Eisele said the company expects
available retail supplies of Tredaptive to be exhausted by
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.