FDA has received reports of adverse events associated with the use of Fruta Planta, including several cardiac events and one death.

In addition, FDA testing revealed that certain lots of RockHard Weekend and Pandor contain an analogue of sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction.

Fruta Planta poses a threat to consumers because sibutramine (Meridia) is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

Sibutramine is a controlled substance that was withdrawn from the market in October 2010 for safety reasons.

The active drug ingredient (sildenafil) isn’t listed on the labels of RockHard Weekend and Pandor. The lot numbers of affected products are listed here.

The bottom line?

Consumers should stop using these products and throw them away.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

12/23/10 22:26 JR