FDA warns against “Sex Plus”

P.Naina MohamedPharmacologist

                                               

 

                                               

IntroductionThe Food and Drug Administration (FDA) is

advising consumers not to purchase or use “Sex Plus,” a product promoted and sold for sexual enhancement on various websites and in some retail stores on 25th April 2013.

FDA laboratory analysis confirmed that “Sex Plus” contains undeclared sildenafil, tadalafil, sulfosildenafil and dimethylacetildenafil.

Possible Mechanism of Action

Sex Plus

Contains undeclared sildenafil, tadalafil, sulfosildenafil and dimethylacetildenafil

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 NitratesUndeclared ingredients (sildenafil, tadalafil,

sulfosildenafil and dimethylacetildenafil)

Interact with prescription drugs like nitrates (Nitroglycerin)

Excessive dilation of smooth muscle of blood vessels

Lower blood pressure to dangerous levels

Hypotension

Heart Attack

Other InteractionsUndeclared ingredients (sildenafil, tadalafil,

sulfosildenafil and dimethylacetildenafil)

Interacts with Alpha adrenergic blockers, other antihypertensives or CYP3A4 enzyme inhibitors

like Ketoconazole, Erythromycin, Ritonavir

Lower blood pressure to dangerous levels

Hypotension

ConclusionFDA 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/ucm349414.htm 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/drugin

fo/meds/a604008.html http://www.rxlist.com/cialis-tadalafil/drug-2

.htm http://www.medicinenet.com/tadalafil/articl

e.htm http://www.drugs.com/tadalafil.html