FDA Warns Not to Use Fruta Planta Weight-loss Products
PRock Marketing LLC, of Kissimmee, Fla., is voluntarily recalling all lots of Fruta Planta and Reduce Weight Fruta Planta.
Sibutramine is a drug that was withdrawn from the market in December 2010 for safety reasons. People taking sibutramine have an increased risk of cardiovascular events such as heart attack and stroke due to the increase blood pressure and /or heart rate effect of the drug.
The FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta, including several cardiac events and one death.
Fruta Planta and Reduce Weight Fruta Planta poses a threat to consumers as it contains sibutramine. In addition to the increased risk of heart attack and stroke, sibutramine may also interact in life-threatening ways with other medications a consumer may be taking.
Fruta Planta and Reduce Weight Fruta Planta are available in 30-capsule boxes. The products were sold online at www.frutaplanta.com and other online retailers.
Consumers should stop using this product immediately. Consumers should throw the product away in a sealed container where children and animals cannot gain access to it or return it to the company. Consumers may reach the company at 877-225-1009 Monday through Friday from 10:00 a.m. to 4:30 p.m.
Anyone who has experienced negative side effects should consult a health care professional as soon as possible. Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by:
- Completing and submitting the adverse report Online: www.fda.gov/MedWatch/report.htm;
- Downloading the pre-addressed, postage-paid FDA Form 3500 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or
- Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857