(RxWiki News) The FDA is recommending that consumers stop using Fruta Planta immediately due to an undeclared drug ingredient.
Fruta Planta, a product marketed as a dietary supplement for weight loss, is reported to have negative effects on cardiovascular health.
According to results from an FDA laboratory analysis, Fruta Planta contains sibutramine, a medication is known to have adversely affect the coronary system. Sibutramine was taken off the market in October 2010 because it can increase dangers presented to patients of coronary artery disease, congestive heart failure, arrhythmias, or stroke. It is also known to increase blood pressure and pulse rate.
Due to reports of several cardiac events and one death, the FDA recommends that consumers stop using Fruta Planta, throw it away, and see a health care professional in any case where negative side effects are experienced. They also recommend that health care professionals and patients report those cases of negative side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178