* European agency had urged halt to sibutramine sales
* Drug to remain available outside Europe
* U.S. FDA says drug raises heart risks for some
* Abbott shares fall 1.2 pct
(Recasts with Abbott suspending European sales; updates
By Lisa Richwine
WASHINGTON, Jan 21 Abbott Laboratories (ABT.N)
said on Thursday it will suspend European sales of a weight-
loss pill in the face of a recommendation by regulators that
heart-related risks made the prescription drug too dangerous.
The European Medicines Agency urged a halt to sales of
drugs containing sibutramine, which are sold under the names
Reductil, Reduxade and Zelium in Europe and Meridia in the
"The risks of these medicines are greater than their
benefits," EMEA said in its recommendation to the European
Commission, adding that weight loss with the drugs is "modest"
and may not last after treatment is stopped.
Abbott will comply with the recommendation even though "we
respectfully disagree" and "believe there are many patients who
benefit" from the drug, company spokesman Kurt Ebenhoch said.
The medicine will remain available outside of Europe, he
said. Meridia's global sales were about $300 million in 2009.
In the United States, the Food and Drug Administration said
it concluded the drug increased the chances of a heart attack
or stroke for people with cardiovascular disease.
The FDA said Abbott agreed to add a stronger warning that
explicitly states the drug should not be used in patients with
a history of cardiovascular disease. That includes people who
have had heart attacks, strokes, irregular heart beats and
uncontrolled high blood pressure.
The FDA said it would hold an advisory committee meeting to
ask outside experts if more regulatory action was needed.
The meeting will take place after the agency reviews a full
report from a study called Scout, which tested Meridia compared
with a placebo in about 10,000 patients. The FDA said it
expected Abbott to submit the full Scout results in March.
Preliminary data showed 11.4 percent of patients who took
Meridia died or had a heart attack, stroke or cardiac arrest
compared with 10 percent for patients who took a placebo.
The FDA said its review showed the higher heart risks
extended only to patients with a history of cardiovascular
disease. The agency advised patients to discuss with their
doctors if continued use was appropriate.
Abbott's Ebenhoch said the drug had a "positive benefit
risk profile when used appropriately in the approved patient
Meridia is an appetite suppressant approved to treat obese
adults. Its side effects range from headaches and constipation
to higher blood pressure and a faster heart rate.
Obesity itself raises the risk of serious health problems
such as heart attacks and diabetes.
Consumer group Public Citizen has asked the FDA to ban the
drug, saying it is too risky.
Abbott shares fell 1.2 percent to close at $55.56 on the
New York Stock Exchange.
(Additional reporting by Ben Hirschler; editing by Lisa Von
Ahn, Gary Hill and Andre Grenon)