FDA’s Notification on S.W.A.G

Dr. P.Naina MohamedPharmacologist

Introduction

On 16th Apr 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use S.W.A.G (Sex With A Grudge).

S.W.A.G is promoted and sold for sexual enhancement on various websites, including www.SexWithAGrudge.com, and in some retail stores.

 FDA laboratory analysis confirmed that S.W.A.G contains Sildenafil.

Sildenafil is a Phosphodiesterase 5 (PDE 5) inhibitor, useful for the treatment of Erectile Dysfunction (ED).

Possible Mechanism of Action

S.W.A.G (Sex With A Grudge)

Undeclared Sildenafil

Inhibition of Phosphodiesterase 5 (PDE 5)

Inhibition of Breakdown of cGMP

Increase the concentration of cGMP in smooth muscle of corpus cavernosum and

penile arteries

Smooth muscle relaxation

Increase the blood flow to corpus cavernosum

Penile Erection

Interaction with Nitrates

S.W.A.G (Sex With A Grudge)

Undeclared Sildenafil

Interact with prescription drugs like nitrates (Nitroglycerin)

Excessive dilation of smooth muscle of blood vessels

Potentiation of Hypotensive effects

Blood pressure reduced to dangerous levels

Contraindicated

Interaction with Protease Inhibitors (Antiretrovirals)

S.W.A.G (Sex With A Grudge)

Undeclared Sildenafil

Interact with Protease Inhibitors like Saquinavir, Ritonavir, Indinavir, Nelfinavir, Amprenavir,

Fosamprenavir, Lopinavir, Atazanavir, , Tipranavir and Darunavir

Protease Inhibitors block CYP3A4-mediated sildenafil metabolism

Increased plasma levels of sildenafil

Increased risk of sildenafil adverse effects (hypotension, visual changes, priapism)

Contraindicated

Interaction with CYP3A4 Inhbitors

S.W.A.G (Sex With A Grudge)

Undeclared Sildenafil

Interact with CYP3A4 Inhibitors like Macrolide antibiotics (Telithromycin, Erythromycin,

Clarithromycin) and Antifungals (Voriconazole, Itraconazole, Ketoconazole)

CYP3A4 Inhibitors block CYP3A4-mediated sildenafil metabolism

Increased plasma levels of sildenafil

Increased risk of sildenafil adverse effects (hypotension, visual changes, priapism)

Conclusion

FDA warns the Consumers should stop using this product immediately and throw it away. 

FDA advises the Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 

FDA announces to the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.  These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.” 

FDA claims that they are unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients. 

FDA advises the Consumers to exercise caution before purchasing any product in the above categories.

References

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm393557.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

http://www.micromedexsolutions.com Goodman & Gilman's The Pharmacological Basis of

Therapeutics, 12e Laurence L. Brunton, Bruce A. Chabner, Björn C. Knollmann

Harrison's Online Featuring the complete contents of Harrison's Principles ofInternal Medicine, 18e Dan L. Longo, Anthony S. Fauci, Dennis L. Kasper, Stephen L. Hauser, J. Larry Jameson, Joseph Loscalzo, Eds.

Hurst's The Heart, 13eValentin Fuster, Richard A. Walsh, Robert A. Harrington

Basic & Clinical Pharmacology, 12e Bertram G. Katzung, Susan B. Masters, Anthony J. Trevor

Clinician's Pocket Reference, 11eLeonard G. Gomella, Steven A. Haist

References

http://www.nlm.nih.gov/medlineplus/druginfo/meds/a699015.html

http://www.rxlist.com/viagra-drug/clinical-pharmacology.htm

http://www.medicinenet.com/sildenafil/article.htm

http://www.pfizer.com/files/products/uspi_viagra.pdf