-Merck cautions about use of Zocor with heart drug
(Adds details, closing share price)
By Ransdell Pierson and Edward Tobin
NEW YORK, June 6 (Reuters) - Merck & Co. <MRK.N> on
Thursday said the label for its cholesterol fighter Zocor had
been changed to indicate a potentially dangerous interaction
with the drug Cordarone, used to treat irregular heartbeats.
The New Jersey-based drug giant said the Zocor label now
cautions that patients taking Wyeth's <WYE.N> Cordarone should
not take any dose of Zocor above 20 milligrams -- which is the
suggested starting dose of Merck's cholesterol treatment that
racked up sales last year of $6.7 billion.
Merck spokesman Greg Reaves said the Zocor label now states
that patients taking higher doses of Zocor with Cordarone have
a greater chance of developing serious muscle weakness and a
potentially deadly form of skeletal muscle wasting called
rhabdomyolysis.
Zocor, which is available in a range of doses between 10
milligrams and 80 milligrams, is Merck's top-selling product.
It competes with Pfizer Inc's <PFE.N> blockbuster Lipitor and
Bristol-Myers' Squibb Co's <BMY.N> Pravachol.
Reaves said the label had previously cautioned about
possible similar interactions of Zocor with other medicines,
including another heart drug called verapamil, several
antibiotics and protease inhibitors to treat HIV.
He said Merck noticed the interaction with Cordarone in its
normal course of reviewing case reports among patients taking
Zocor, a member of the popular "statin" class of
cholesterol-lowering medicines.
"We remain confident in the established safety and
effectiveness of Zocor," Reaves said.
Shares of Merck closed down $1.75, or 3.2 percent, to
$53.20 on Thursday on the New York Stock Exchange amid a 3
percent decline in the American Stock Exchange Pharmaceutical
Index <.DRG>.
Regulators are hyper-sensitive to safety issues surrounding
cholesterol drugs following last year's forced withdrawal of
Bayer AG's <BAYG.DE> Baycol due to incidents of muscle-wasting,
which were linked to around 100 deaths.
"This new Zocor language highlights some of the concerns
that have been expressed with these drugs. There is an
increased risk at high doses and an increased risk when used in
combinations with certain drugs," said analyst Robert Hazlett
of Robertson Stephens.
Several other analysts said the label change could make
some doctors somewhat more careful about prescribing Zocor,
although its sales would likely not be badly hurt.
"The stronger labeling will provide ammo for competitors,
but we believe the physician community is already well aware
of, and sensitized to, this issue," Deutsche Bank Securities
analyst Barbara Ryan said in a research note.
"In our view, it will not have a major impact on the
prescribing habits of Zocor users, though it may may discourage
doctors from pushing Zocor doses (to higher levels)," she
added.
Ryan said she is not changing her revenue estimates for
Zocor and reiterated a "market perform" rating on Merck stock.
Prudential Securities analyst Tim Anderson said the label
change could have a "negative impact" on Zocor's sales in the
United States. But he said he was sticking to his forecast that
the drug would have sales of $7.3 billion in 2002 and $7.6
billion the following year.
((Health Desk, 646 223-6034))
REUTERS |
