Monday, October 11, 2010

FDA Banned Obesity Drug for the Risk of Heart Attack!!

Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.

Meridia was approved by the FDA in November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving sibutramine lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.

The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given sibutramine compared to another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.


For more info: Please visit: meridia.

Monday, July 12, 2010

Calorie info on menus & total calories, fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, a

July 7, 2010

The U.S. Food and Drug Administration (FDA) today announced the opening of a docket to gather public comment and information to help the agency implement a new federal law that requires the posting of calorie content and other nutrition information on menu items at certain chain restaurants and similar retail food operations and vending machines.

The new law, Section 4205 of the Affordable Care Act signed into law March 23, 2010, sets new federal requirements for foods sold at certain restaurants, coffee shops, delis, movie theaters, bakeries, ice cream shops, and vending machines.

Prior to the new law, federal law already required nutrition labeling on many packaged foods, which may be purchased in supermarkets and at other locations, and some states and local governments required nutritional labeling by restaurants in their jurisdictions.

The new law requires restaurants and similar retail food establishments which are part of a chain with 20 or more locations that offer substantially the same menu items to list calorie content information on menus and menu boards, including drive-through menu boards.

Other nutrient information – total calories, total fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein – must be made available in writing on request. The act also requires vending machine operators who own or operate 20 or more vending machines to disclose calorie content for certain items.

The FDA is required by law to issue proposed regulations to carry out these provisions by March 23, 2011. The agency also expects to issue guidance concerning the requirements of Section 4205 of the Affordable Care Act.

For more information:
Docket No. FDA-2010-N-0298

Tuesday, May 11, 2010

What we are eating!

DAILY STAR

Nothing is pure in the world of foods

Availability of unadulterated food items in the local markets is difficult as wholesalers mix everything - from brick dust, soap ingredients to textile dyes – with commonly eaten foods, writes Pianki Roy. The article says that dishonest producers use textile and leather dyes to change the colour of confectionary products, beverage, sweet meats and other snacks. It quotes officials from the Consumer Association of Bangladesh as saying that most of the red chilli powers used in the marker are adulterated with brick dust.