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

1. Voluntary Recall of Lot
2510 of Jack Rabbit
P.Naina Mohamed
Pharmacologist

2. 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.

3. 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

4. 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

5. Interaction with
Antihypertensives
Undeclared ingredients (Sildenafil and Tadalafil)
Interact with Alpha adrenergic blockers and other
antihypertensives
Lower blood pressure to dangerous levels
Hypotension

6. 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

7. 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

8. 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.

9. 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

10. 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