Fruta Planta Weight Loss Drug Recall: Contains Meridia
A chain of weight loss products have been found to contain the active ingredient from Meridia, which was recalled last year due to an increased risk of heart attacks and strokes, leading the FDA to call for the removal of all Fruta Planta products from store shelves.
The Fruta Planta recall was announced on December 31, after the FDA determined that the drug, marketed by PRock Marketing, LLC, of Kissimmee, Florida, contained sibutramine.
Marketed as Meridia by Abbott Laboratories, sibutramine was first approved by the FDA as a prescription-only weight loss supplement in 1997. However, in October, the FDA announced a Meridia recall due to an increased risk of cardiovascular problems from sibutramine, while the medication provided very little actual weight loss benefit for consumers.
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In late 2009, the findings of a clinical trial called SCOUT, found that sibutramine increased the risk of serious heart events, such as heart attacks and strokes, by 16%, while finding only a small difference in the weight loss between people given Meridia and those given a placebo. The FDA said that the SCOUT data and the agency’s subsequent review led it to the decision to ask Abbott Laboratories to remove Meridia.
An investigation of Fruta Planta was initiated after the FDA received a number of reports that users had suffered cardiac events. There has also been at least one death associated with the product as well.
The recall affects all lots of Fruta Planta and Reduce Weight Fruta Planta, which are the same product. The FDA’s warning says that Fruta Planta poses a threat to consumers because it is known to increase blood pressure and pulse rate in some patients and can put those with a history of heart problems and stroke at increased risk.
The FDA recommends that consumers stop using Fruta Planta immediately and if they experience any negative side effects they should consult a health care professional as soon as possible. The company is recommending that consumers dispose of the drugs in a safe manner or return it to the company. It is unclear whether PRock Marketing is offering a refund for returned Fruta Planta products.
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