Generic Levitra (Vardenafil)

Georgia-based Hi-Tech Pharmaceuticals has issued a total recall of its “sexual stimulant” dietary supplement, after it was found to be contaminated with the banned substance, benzamidenafil.

After Food and Drug Administration (FDA) testing revealed the presence of the non-authorised constituent in one batch of Stamina Rx, Hi-Tech voluntarily instigated a recall of all batches.

It advised consumers to stop using the supplement and published a number to call for those who may have suffered an adverse event. Consumers were also advised to contact the FDA Medway web site.

Benzamidenafil is not listed on Stamina-Rx’s ingredients list and is similar to active ingredients in erectile dysfunction drugs like Viagra, Cialis, and Levitra.

“Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels,” said Hi-Tech in a statement.

“Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.”

Stamina-Rx contains two proprietary ingredients: Xanthoparmelia Scabrosa and Cnidium Monnier as well as yohimbe extract, L-Arginine, Gamma Amino Butyric Acid (GABA) and epimedium (Horny Goat Weed).

Product marketing said Stamina-Rx could,“Increases the sex drive as effectively as any compound known to science!”

Stamina Rx and Stamina Rx for Women previously drew regulator attention when in 2003, it was found to contain the prescription drug ingredient, tadalafil, the active constituent in Cialis, Eli Lilly’s erectile dysfunction drug that was at time approved in Europe but no the US.

Results from a five-patient case report suggest that the combined protocol of vardenafil plus sertraline is an effective and well-tolerated treatment for temporary erectile dysfunction during assisted reproductive technologies (ART).

Zi–jiang Chen (Shandong University, Jinan, China) and co-authors say that this protocol “avoids the risks for surgical procedures in most cases and prevents a delay in insemination which may compromise the ART results.”

The researchers identified five patients with unexpected ejaculation failure during IVF treatment who attributed this failure to high stress levels and severe anxiety.

Initially, two patients who could not produce a semen sample 3 hours after taking 50 mg of the phosphodiesterase-5 inhibitor (PDE5-I) sildenafil, were given 10 mg of another PDE5-I, vardenafil plus 50 mg sertraline, a selective serotonin reuptake inhibitor (SSRI). Both men were able to provide a semen sample 1-2 hours later.

Chen and co-authors then prescribed vardenafil and sertraline for three other patients with temporary ejaculation failure, and got sperm samples without difficulty 2 hours later. As with the other two men, no side effects were noted.

“The results show that vardenafil plus SSRI had a higher success rate than SSRI alone, and was better than lidocaine application or SSRI treatment alone in terms of the International Index of Erectile Function score and premature ejaculation grades,” says the team.