FDA warns Novacare about blood pressure side effects with ED drug
The FDA notified Novacare that certain products appear to contain sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug for erectile dysfunction (ED). Sulfoaildenafil is not declared on the product labels, according to the agency, and the undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates, the FDA said.
This warning said the affected products are sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45 and Zilex (with Golden Spear).
The recalled products listed above were distributed in bottles and/or "blister cards" to retailers and via internet sales. All lots of the above-named products with manufacture or distribution dates prior to June 17 are being recalled.
Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates, the FDA said.
This warning said the affected products are sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45 and Zilex (with Golden Spear).
The recalled products listed above were distributed in bottles and/or "blister cards" to retailers and via internet sales. All lots of the above-named products with manufacture or distribution dates prior to June 17 are being recalled.