Copyright 2002 The Associated Press.
All rights reserved. July 24 —
WASHINGTON (AP) Women who suffer constipation-causing irritable bowel
syndrome won their first government-approved treatment Wednesday. But
while its maker predicts Zelnorm will prove a blockbuster, a critic
contends health authorities should not have let it be sold.
Zelnorm's approval comes just weeks after the Food and Drug
Administration let another controversial bowel drug, Lotronex, back on
the market, two years after serious side effects halted its sales.
The two drugs are for different types of irritable bowel syndrome, a
mysterious disorder that gives millions of Americans, mostly women,
abdominal pain and either severe diarrhea or constipation or both.
Lotronex is for the diarrhea type, while Zelnorm on Wednesday became the
only FDA-approved therapy for women with constipation-predominant IBS.
Until now, these women could try laxatives, but they did not relieve
the cause of IBS. Zelnorm appears to go a step further, acting on nerve
cells to speed the colon's movement of stools.
It is far from a cure. In studies, patients fared only a little
better 5 percent to 11 percent better when taking Zelnorm than when
taking dummy pills.
It has not been studied in men, and seems to work best the first
month before its effects wane after three months of treatment, the FDA
concluded.
Still, the government was on track to approve Zelnorm a year ago when
instead it abruptly halted, citing concern about an increase in gall
bladder and other abdominal operations among patients testing the drug.
European regulators raised similar concerns.
On Wednesday, the FDA reversed course and approved Zelnorm's sale,
saying the extra surgeries so far appear to be coincidence.
To be sure, the FDA ordered Zelnorm maker Novartis to study how
patients fare as sales begin, and pledged to closely monitor any reports
of side effects.
"We're all very interested in looking at this to make sure it doesn't
turn out to be something unwanted," said Dr. Joyce Korvick, FDA's deputy
director of gastrointestinal drugs.
A consumer advocacy group attacked the FDA's decision, saying
officials were ignoring early signals of Zelnorm risks just as the
agency two years ago downplayed a few bowel inflammations and other
complaints that eventually derailed Lotronex.
"It's another serious, reckless mistake for the FDA," said Dr. Sidney
Wolfe of the advocacy group Public Citizen. He contends there is no
proof Zelnorm relieves constipation better than laxatives such as
Metamucil.
Wolfe said potential Zelnorm users should know not only about the
surgery issue nine operations among 2,965 Zelnorm users versus three
among 1,740 women who got dummy pills but also that Zelnorm may cause or
worsen ovarian cysts. Studies show Zelnorm can cause such cysts in
animals, and a few Zelnorm users have them, too, he said.
The FDA's Korvick said most of those women had cysts when they
started taking Zelnorm, but she acknowledged no one knows if the drug
worsened them.
"I thought the drug got a clean bill of health," added Jeff Roberts
of the IBS Self Help Group, a patient group that has pushed the FDA to
approve treatments for the illness. He said some U.S. patients already
are buying Zelnorm abroad, unwilling to await the FDA approval.
Novartis says its research accounted for Zelnorm users who also
swallowed laxatives, and concluded that Zelnorm added benefit,
particularly in relieving pain.
While that benefit appears small on paper, most patients do say they
feel better, an important consideration, added gastroenterologist Dr.
Susan Lucak of Columbia University, a Novartis consultant.
Novartis said sales should begin in early fall. Novartis has
estimated Zelnorm will generate $1 billion in annual sales; it refused
to release the actual price but suggested the tablets will be "in the
range" of $3 to $4 each. Patients would generally take two a day.
Novartis is working with European regulators to determine what
additional testing will be needed before Zelnorm can sell there, a
spokeswoman said.
Copyright 2002 The Associated Press. All rights reserved. This
material may not be published, broadcast, rewritten, or redistributed.
|
World News Tonight
PRINT THIS PAGE
