FDA’s warning against GoldReallas

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On 2nd June 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use “GoldReallas”.

GoldReallas is promoted and sold for sexual enhancement on various websites and in some retail stores.

FDA laboratory analysis confirmed that GoldReallas contains Sildenafil and Thiosildenafil.

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FDA’s warning against GoldReallas

  1. 1. FDA’S WARNING AGAINST “GOLDREALLAS” Dr. P.Naina Mohamed Pharmacologist
  2. 2. INTRODUCTION  On 2nd June 2014, The Food and Drug Administration (FDA) is advising consumers not to purchase or use “GoldReallas”.  GoldReallas is promoted and sold for sexual enhancement on various websites and in some retail stores.  FDA laboratory analysis confirmed that GoldReallas contains Sildenafil and Thiosildenafil.  Sildenafil is a Phosphodiesterase 5 (PDE 5) inhibitor and is approved for the treatment of Erectile Dysfunction (ED).  Thiosildenafil is a substance structurally similar to sildenafil.
  3. 3. POSSIBLE MECHANISM OF ACTION GoldReallas Undeclared Sildenafil and Thiosildenafil 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
  4. 4. INTERACTION WITH NITRATES GoldReallas Undeclared Sildenafil and Thiosildenafil 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
  5. 5. INTERACTION WITH PROTEASE INHIBITORS (ANTIRETROVIRALS) GoldReallas Undeclared Sildenafil and Thiosildenafil 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
  6. 6. INTERACTION WITH CYP3A4 INHBITORS GoldReallas Undeclared Sildenafil and Thiosildenafil 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)
  7. 7. 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.
  8. 8. REFERENCES  http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingU singMedicineSafely/MedicationHealthFraud/ucm399612.htm?sour ce=govdelivery&utm_medium=email&utm_source=govdelivery  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 of Internal Medicine, 18e Dan L. Longo, Anthony S. Fauci, Dennis L. Kasper, Stephen L. Hauser, J. Larry Jameson, Joseph Loscalzo, Eds.  Hurst's The Heart, 13e Valentin Fuster, Richard A. Walsh, Robert A. Harrington  Basic & Clinical Pharmacology, 12e Bertram G. Katzung, Susan B. Masters, Anthony J. Trevor  Clinician's Pocket Reference, 11e Leonard G. Gomella, Steven A. Haist
  9. 9. REFERENCES http://www.micromedexsolutions.com http://www.nlm.nih.gov/medlineplus/d ruginfo/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/u spi_viagra.pdf

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