fda’s warning against_mv5_days
DESCRIPTION
On 16th May 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use MV5 Days.TRANSCRIPT
FDA’s Notification on mv5 Days
Dr. P.Naina Mohamed
Pharmacologist
Introduction On 16th Apr 2014, The Food and Drug
Administration (FDA) is advising consumers not to purchase or use MV5 Days.
MV5 Days is promoted and sold for sexual enhancement on various websites and in some retail stores.
FDA laboratory analysis confirmed that MV5 Days contains Sildenafil.
Sildenafil is a Phosphodiesterase 5 (PDE 5) inhibitor and is useful for the treatment of Erectile Dysfunction (ED).
Possible Mechanism of ActionMV5 Days
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 NitratesMV5 Days
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)
MV5 Days
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 Inhibitors
MV5 Days
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/ucm397707.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
Referenceshttp://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