Pureheart 2015-12-08 16:03:41
RPT-UPDATE – Schering-Plough adds warning to drug label Monday June
30, 4:47 pm ET By Toni Clarke
(Updates with closing share prices)
NEW YORK, June 30 (Reuters) – Schering-Plough Corp. (NYSE:SGP – News)
on Monday said it has altered the label for its cholesterol drug Zetia
to include a warning that the drug can cause allergic reactions,
including angioedema and rash.
Angioedema is characterized by swelling of one or all of the hands,
feet, eyelids and lips. Sometimes the membranes lining the mouth,
throat and airways swell, making breathing difficult. In severe cases,
it can prove fatal.
Schering-Plough said it decided to update the label following routine
monitoring of reports of adverse events.
The company declined to reveal the number of people affected by the
allergic reactions. It said only that none of the cases were
life-threatening. An official from the U.S. Food and Drug
Administration (News – Websites) was unable to immediately answer the
Schering-Plough, which is marketing the drug with Merck & Co.
(NYSE:MRK – News), said it submitted its new label to the FDA in
April, and that it will be in the market in July.
Zetia was approved last October and had sales of $46 million in the
first quarter. The companies expect to combine Zetia with Merck’s
blockbuster cholesterol drug Zocor to form a new multibillion-dollar
Depending on how many people are affected, angioedema can be a serious
An FDA advisory panel last year advised against approving a
hypertension drug made by Bristol-Myers Squibb Co. (NYSE:BMY – News),
saying the beneficial effect of the drug was not enough to offset the
risk of angioedema.
Of 12,000 patients taking Vanlev, 247 developed angioedema. Of those,
two people developed life-threatening symptoms.
Bristol-Myers argued at the time that, at most, six in 10,000 people
would have a life-threatening reaction, and said the side effect could
be managed because it was easily recognized and took hours to develop.
That did not, however, convince the panel to recommend the drug.
Mark McClellan, commissioner of the FDA, told a conference one week
ago that he intends to improve the ways companies report adverse
events to ensure the public does not suffer if drugs are approved more
McClellan said the FDA relies on a voluntary reporting system and that
“the truth is there are countless adverse events that go unreported.”
He said the agency plans to introduce a real-time electronic
monitoring system that will help it improve reporting of side effects.
Schering-Plough’s shares fell 49 cents, or 2.6 percent, to close at
$18.60 on the New York Stock Exchange (News – Websites). Merck’s
shares fell 47 cents to $60.55.
(Additional reporting by Jed Seltzer and Bill Berkrot)