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Seeger Weiss Blog: Legal News and Analysis

Category : Meridia

FDA refuses to approve another diet drug

November 11th, 2010

From the Washington Post blog, The Checkup:

The agency sent a letter to the drugmaker raising a variety of concerns about Qnexa, according to Vivus Inc., of Mountain View, Calif., which had sought the drug’s approval. The letter does not bode well for the drug winning approval.

The move was expected, given that an FDA advisory panel had voted against the drug’s approval in July because of evidence it may have adverse side effects, including increasing the risks for birth defects during pregnancy.

But the step is the latest in a series of setbacks in the effort to develop new weight-loss drugs. The FDA last week rejected approval of lorcaserin because of it appeared to cause tumors in rats. And earlier this month the agency forced the removal of the the drug Meridia from the market because it appears to increase the risk for heart attacks and strokes.

Diet drug Meridia pulled over heart attack, stroke issues

October 26th, 2010

From the Washington Post blog, The Checkup:  Concerns for Roche Holding AG’s Accutane acne medication, Pfizer’s Bextra painkiller and Abbott Laboratories’ weight-loss drug Meridia were earlier expressed by FDA medical reviewer David Graham who told a U.S. Senate panel that the U.S. Food and Drug Administration should scrutinize the drugs’ side effects.

Ta-Nehisi Coates on the so-far ineffective struggle to create a safe weight loss pill

October 12th, 2010

Ta-Nehisi Coates on the so-far ineffective struggle to create a safe weight loss pill: “It’s still all a dream…I wonder what the long-term effects of weight-loss pill would be?”

FDA Withdraws Meridia from the Market

October 11th, 2010

Washington Post:

Sidney Wolfe of Public Citizen’s Health Research Group, which had petitioned the FDA to remove Meridia, noted that while European regulators recently pulled two other drugs – the pain pill Darvon and the long-controversial diabetes drug Avandia – both remain available in the United States.

“Both of these unacceptably dangerous drugs remain on the market in this country, predictably injuring or killing many people, who, unlike their European counterparts, do not have the government protecting them from drugs with no unique benefits but significant, unique risks,” Wolfe said.

Meanwhile, in yet more bad news for people trying to lose weight, the FDA also warned Friday against using “Slimming Beauty Bitter Orange Slimming Capsules,” an herbal product sold over the Internet, because tests found it contains sibutramine.