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| March 09, 2011 |
| Meridia (Sibutramine) Withdrawn From Market Because of Heart Attack and Stroke Risk |
| Posted By DeCarli Law |
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Abbott Laboratories and the FDA reported that the obesity drug Meridia, generic name
Sibutramine, has been voluntarily withdrawn from the market. Clinical trial data indicates the use of
Meridia/Sibutramine increases the risk of heart attack and stroke.
The FDA requested that Meridia be withdrawn from the market after reviewing data from the Sibutramine Cardiovascular Outcomes Trial. The clinical trial 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.
Physicians have been advised to stop prescribing Meridia, and patients should stop taking any Meridia/Sibutramine previously prescribed to them. If you believe you have suffered a side effect or adverse reaction from
Meridia/Sibutramine, you should report it to the FDA. You may do so online
HERE.
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| September 13, 2010 |
| Recalled Diet Drug Solo Slim Contains Synephrine |
| Posted By DeCarli Law |
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The FDA recently ordered the recall of diet drug Solo Slim because it contains an undeclared drug ingredient, Didesmethyl Sibutramine, a risk for people with a history of heart disease. However, Solo Slim also contains Synephrine, another potentially dangerous drug that can cause heart attacks, heart palpitations, strokes, and even death.
Synephrine (or oxydrine) has a chemical structure similar to ephedrine. Because of its similarity to ephedrine, Synephrine can cause similar side effects. Based on the potential for cardiovascular toxicity of Synephrine, Health Canada in January 2010 issued guidelines limiting the maximum dose of Synephrine, and prohibiting the sale of health products containing both Synephrine and caffeine without prior submission of clinical evidence of the product’s safety.
Thus, Solo Slim contains two different drugs that can cause heart attacks and strokes. Further, Solo Slim also contains caffeine, which in combination with Synephrine was regarded as potentially dangerous in itself by the Canadian health agency. This chemical makeup makes Solo Slim particularly dangerous for people with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
As we reported in an earlier post, consumers should return Solo Slim immediately to the place of purchase for a full refund, and contact their physician if they experience any side effects as a result of taking the product. |
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