* FDA says use of Merida not worth the risks
* Drugmaker still says drug works in certain patients
* Move could impact rival obesity drugs
* Shares close up less than one percent
(Adds analyst comment, consumer advocate reaction, updates
shares to close)
By Susan Heavey
WASHINGTON, Oct 8 Abbott Laboratories' (ABT.N)
has pulled its controversial diet drug, Meridia, off the U.S.
market after regulators said it was too dangerous, making it
the latest casualty in the troubled obesity drug sector.
Although Abbott argued that its drug was safe, Food and
Drug Administration officials said on Friday available data
highlighting the Meridia's heart risks raised serious questions
about its use.
"Meridia's continued availability is not justified when you
compare the very modest weight loss that people achieve on this
drug to their risk of heart attack or stroke," John Jenkins,
director of FDA's Office of New Drugs, said in a statement.
Abbott, in a statement, said it would comply with the FDA's
request to withdraw Meridia even though it still thinks the
drug is safe. It also said it was discussing the fate of
Meridia in other countries and expects those talks to end in
the coming days. European sales were halted in January.
For a factbox, click on [ID:nN08118745]
Meridia has been under fire over its increased risk of
heart attack and strokes in certain patients, and last month
the FDA's outside advisers urged the agency to take some kind
of tougher action against Meridia, first approved in 1997.
While Meridia's removal does little to dent Abbott's bottom
line, it highlights the FDA's concerns about safety issues in
obesity drugs and could affect the fate of potential rivals.
It also shows the difficulty in treating overweight or
obese patients through medication in a country where two out of
every three people are too heavy. While weight can be managed
through diet and exercise, drugmakers have struggled for more
than a decade to bring about a successful drug to shed pounds.
Arena Pharmaceuticals Inc (ARNA.O), Orexigen Therapeutics
Inc (OREX.O) and Vivus Inc (VVUS.O) are all seeking approval
for weight loss drugs they hope will be safer.
Herman Saftlas, a healthcare analyst for Standard & Poor's
Equity Research, said,"Meridia was relatively insignificant,"
given Abbott's size. The drugmaker saw net sales of $30.8
billion last year but expected just $30 million from U.S. sales
of Meridia in 2010.
Shares of Abbott closed up 0.4 percent at $52.80 on the New
York Stock Exchange. Arena shares ended up 1.8 percent and
shares of Vivus were near flat, while shares of Orexigen were
up 1.3 percent, all on the Nasdaq.
Consumer groups have been fighting for Meridia's removal
for years and welcomed the FDA's decision even as they said it
took took long and put patients at risk.
Sidney Wolfe, director for Public Citizen's Health Research
Group, said the drug's ban comes "dangerously too late for all
of the victims of its unacceptable risks."
The FDA estimates about 100,000 people in the United States
use Meridia. But, Wolfe said more than 160,000 prescriptions
for the have been filled since January and more than than 3
million prescriptions have been filled since 2002.
Abbott said patients should stop using Meridia, also known
as sibutramine, and ask their doctor about other medications.
But such alternatives have their own problems.
Orlistat, sold as Roche Holding AG's ROG.VX prescription
drug Xenical or over-the-counter as GlaxoSmithKline Plc (GSK.L)
lower-dose version Alli, can cause serious liver problems,
uncontrolled bowel movements and gas.
Two other prescription drugs, phentermine and
diethylpropion, are also available for more short-term
weight-loss use and are sold generically.
"We actually have very few options," Dr. Mitchell Roslin,
chief of obesity surgery at Lenox Hill Hospital in New York,
said, citing lifestyle changes through diet and exercise as
well as surgery as other possibilities.
Safety issues are also a concern for pending rivals.
In September, another FDA advisory panel rejected Arena's
lorcaserin in the face of potential cancer risks and causing
investors to flee the stock.
FDA advisers also rejected Vivus' candidate, Qnexa, back in
July over concern about depression, memory loss and potential
birth defects. Orexigen faces FDA's advisers in December over
its drug, Contrave.
No final FDA decision has been made for the three drugs.
"We are committed to working toward approval of new
products so long as they are safe and effective," Jenkins told
reporters in a conference call, adding that obesity carries its
own risks of diabetes, heart disease and other problems.
Dr. Mark Molitch of Northwestern University Feinberg School
of Medicine in Chicago, had voted against Meridia's approval in
1997 but said doctors are still desperately seaching for a tool
to fight the U.S. bulge.
"Clearly, lifestyle changes are what is needed, but it
doesn't work," he said. "We are all getting fatter in this
country and around the world."
(Reporting by Susan Heavey; Additional reporting by Julie
Steenhuysen in Chicago; Editing by Derek Caney, Leslie