Voluntary Recall of Lot 2510 of Jack Rabbit

P.Naina MohamedPharmacologist

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 ActionJack 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=govd

elivery&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 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/druginfo/

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

m http://

www.medicinenet.com/tadalafil/article.htm http://www.drugs.com/tadalafil.html