Prolatis’ and the FDA announced a nationwide voluntary recall of its product Prolatis’ after lab analysis found the product to contain undeclared sulfoaildenafil. Sulfoaildenafil is an analogue of sildenafil, an FDA-approved drug used as treatment for erectile dysfunction (ED). The undeclared ingredient may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, hypertension, hyperlipidemia, or cardiac disease often take nitrates.
Consumers who have this product in their possession should stop using it immediately and contact their healthcare professional if they experience any adverse effects related to the use of Prolatis’.
For more information call or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222327.htm.