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Abbott Laboratories' has pulled its controversial diet drug, Meridia, off the US 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.
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, Orexigen Therapeutics Inc and Vivus Inc 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 USD 30.8 billion last year but expected just USD 30 million from US sales of Meridia in 2010.
Shares of Abbott closed up 0.4% at USD 52.80 on the New York Stock Exchange. Arena shares ended up 1.8% and shares of Vivus were near flat, while shares of Orexigen were up 1.3 percent, all on the Nasdaq.
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