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Voluntary recall of jack rabbit
 

Voluntary recall of jack rabbit

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FDA posts the announcement of Jack Rabbit Inc. regarding its voluntary recall of “Jack Rabbit” on 12th Aug 2013.

FDA posts the announcement of Jack Rabbit Inc. regarding its voluntary recall of “Jack Rabbit” on 12th Aug 2013.

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    Voluntary recall of jack rabbit Voluntary recall of jack rabbit Presentation Transcript

    • Voluntary Recall of Lot 2510 of Jack Rabbit P.Naina Mohamed Pharmacologist
    • Introduction  The Food and Drug Administration (FDA) posts the announcement of Jack Rabbit Inc. regarding its voluntary recall of one lot of the company's dietary supplement product sold under the name “Jack Rabbit” on 12th Aug 2013.  The lab analysis by Food and Drug Administration (FDA) for Lot 2510 found that the product contains sildenafil and Tadalafil.  Sildenafil and Tadalafil are not listed on the product label.  The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.  Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.  The product may cause side effects, such as headaches and flushing.
    • Possible Mechanism of Action Jack Rabbit 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
    • Interaction with Nitrates Undeclared ingredients (Sildenafil and 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
    • Interaction with Antihypertensives Undeclared ingredients (Sildenafil and Tadalafil) Interact with Alpha adrenergic blockers and other antihypertensives Lower blood pressure to dangerous levels Hypotension
    • Interaction with CYP3A4 inhibitors Undeclared ingredients (Sildenafil and Tadalafil) Interact with CYP3A4 enzyme inhibitors like Ketoconazole, Erythromycin, Ritonavir Lower blood pressure to dangerous levels Hypotension
    • Adverse Effects Jack Rabbit may cause side effects, such as headaches and flushing. Jack Rabbit Contains undeclared Sildenafil and Tadalafil Inhibition of Phosphodiesterase 5 (PDE 5) Vasodilation Headache and Flushing
    • Conclusion  Jack Rabbit Pack is marketed as a dietary supplement for sexual enhancement.  Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.  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/Safety/Recalls/ucm365720.htm? source=govdelivery&utm_medium=email&utm_source=govd elivery  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
    • References  http://www.nlm.nih.gov/medlineplus/druginfo/ meds/a604008.html  http://www.rxlist.com/cialis-tadalafil/drug- 2.htm  http://www.medicinenet.com/tadalafil/article.h tm  http://www.drugs.com/tadalafil.html