Meridia, Generic Name Sibutramine, Causes Heart Attacks and Strokes

Meridia, generic name Sibutramine, is an obesity drug manufactured by Abbott Laboratories. The FDA requested that Meridia be withdrawn from the market in October 2010, after clinical trial data revealed that its use caused a 16% increase in the risk of serious cardiac events, including death, heart attacks, strokes, and the need to be resuscitated after the heart stopping.

Meridia was approved 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. It was originally manufactured and sold by Knoll Pharmaceutical, but most recently by Abbott Laboratories.

Meridia/Sibutramine Withdrawn from Market First in Europe, then in the USA

Concerns about Meridia/Sibutramine were first raised in 2002, when NGO Public Citizen petitioned the FDA to ban the drug. Although Senate hearings were held in 2005, the FDA took no action. However, the European Medicines Agency recommended that Sibutramine be withdrawn from the market on January 21, 2010, after a six-year study showed an increased risk of non-fatal but serious cardiovascular events in patients with a known or high risk of cardiovascular disease.

After the action by the European agency, the FDA reviewed data from the Sibutramine Cardiovascular Outcomes Trial, which was part of a postmarket requirement to look at cardiovascular safety of Sibutramine after its initial approval in Europe. The trial found 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 even death, in a group of patients given Sibutramine, compared with those given only a placebo. There also was only a small difference in weight loss between the placebo group and the group that received sibutramine. As a result of the review of this data and reports of adverse events, the FDA requested that Meridia be removed from the market.

Sibutramine Often an Undisclosed Ingredient in Over-the-Counter Diet Drugs

Even now that Sibutramine has been withdrawn from the market, it still poses a risk to consumers because it is frequently found in so-called “herbal” and “natural” weight loss products. Many products have been found to contain Sibutramine, even though it is not disclosed as an ingredient. Svelte 30, Celerite Slimming Capsules, Que She, Fruta Planta, Slim-30, Joyful Slim Herb Supplement, and Slimming Beauty Bitter Orange are just a few of the over-the-counter products found to have Sibutramine as an undisclosed ingredient.

Meridia/Sibutramine Lawsuits

If you or a loved one has suffered a side effect such as a heart attack, stroke or even death after taking Meridia/Sibutramine, or an over-the-counter product containing Sibutramine, contact the attorneys at DeCarli Law for a free, no obligation telephone consultation. If you took an over-the-counter product containing Sibutramine, it is important that you do not throw away the packaging, so you can prove that you used the product.