Fda's warning on xzone premium


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Xzone Premium contains undeclared ingredients like Sildenafil, Tadalafil and Dapoxetine which can reduce the blood pressure dangerously by interacting with Nitrates and other drugs.

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Fda's warning on xzone premium

  1. 1. FDA’s Warning on “XZone Premium” P.Naina Mohamed Pharmacologist
  2. 2. Introduction • On 24th Sep 13, The Food and Drug Administration (FDA) is advising consumers not to purchase or use XZone Premium, a product promoted and sold for sexual enhancement on various websites and in some retail stores. • FDA laboratory analysis confirmed that XZone Premium contains sildenafil, tadalafil, and dapoxetine. • Sildenafil and Tadalafil are the drugs approved to treat erectile dysfunction. • Dapoxetine is a selective serotonin reuptake inhibitors (SSRIs) antidepressant and it has the off label use in the treatment of Premature ejaculation. • These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
  3. 3. Possible Mechanism of Action XZone Premium Contains undeclared sildenafil and Tadalafil 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. Possible Mechanism of Action XZone Premium Contains Dapoxetine Inhibition of serotonin transporter Increased serotonin’s action at pre and postsynaptic receptors Modulation of activity of lateral paragigantocellular nucleus (LPGi) neurons Inhibition of ejaculatory expulsion reflex at supraspinal level Increase in pudendal motoneuron reflex discharge (PMRD) latency Delayed ejaculation
  5. 5. Interaction with Nitrates Undeclared ingredient (Sildenafil & Tadalafil) Interact with prescription drugs like nitrates (Nitroglycerin) Excessive dilation of smooth muscle of blood vessels Lower blood pressure to dangerous levels Hypotension Heart Attack
  6. 6. Other Interactions Undeclared ingredient (Sildenafil & Tadalafil) Interacts with Alpha adrenergic blockers, other antihypertensives or CYP3A4 enzyme inhibitors like Ketoconazole, Erythromycin, Ritonavir Lower blood pressure Hypotension
  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/BuyingUsingMed icineSafely/MedicationHealthFraud/ucm369612.htm?source=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.nlm.nih.gov/medlineplus/druginfo/meds/a 699015.html • http://www.rxlist.com/viagra-drug/clinical- pharmacology.htm • http://www.medicinenet.com/sildenafil/article.htm • http://www.rxlist.com/cialis-tadalafil/drug-2.htm • http://www.medicinenet.com/tadalafil/article.htm • http://www.drugs.com/tadalafil.html • http://www.ncbi.nlm.nih.gov/pmc/articles/PMC34411 33/