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Voluntary Recall of 72HP, Evil Root and Pro Power Max P. Naina Mohamed Pharmacologist

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Hardmenstore.com recalled the products such as 72HP, Evil Root and Pro Power Max due to the content of undeclared ingredient Sildenafil.

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Page 1: Voluntary recall of 72 hp, evil root and pro power max

Voluntary Recall of 72HP, Evil Root and Pro Power Max

P. Naina MohamedPharmacologist

Page 2: Voluntary recall of 72 hp, evil root and pro power max

Introduction On 27th Aug 2013, Upon request of the FDA, Hardmenstore.com

is voluntarily recalling 1000 lots of 72HP, Evil Root and Pro Power Max at the consumer level.

FDA analysis found 72HP, Evil Root and Pro Power to contain amounts of the PDE-5 Inhibitor, sildenafil.

Sildenafil is approved for erectile dysfunction (ED) and is not listed on the product labels.

Sildenafil 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 products may cause side effects, such as headaches and flushing.

Page 3: Voluntary recall of 72 hp, evil root and pro power max

Possible Mechanism of Action72HP, Evil Root and Pro Power Max

Contain Sildenafil

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

Page 4: Voluntary recall of 72 hp, evil root and pro power max

Interaction with NitratesUndeclared ingredient (Sildenafil)

Interact with prescription drugs like nitrates (Nitroglycerin)

Excessive dilation of smooth muscle of blood vessels

Lower blood pressure to dangerous levels

Hypotension

Heart Attack

Page 5: Voluntary recall of 72 hp, evil root and pro power max

Interaction with Antihypertensives

Undeclared ingredient (Sildenafil)

Interacts with Alpha adrenergic blockers and other antihypertensives

Lower blood pressure

Hypotension

Page 6: Voluntary recall of 72 hp, evil root and pro power max

Interaction with CYP3A4 inhibitors

Undeclared ingredient (Sildenafil)

CYP3A4 enzyme inhibitors like Ketoconazole, Erythromycin, Ritonavir

Lower blood pressure

Hypotension

Page 7: Voluntary recall of 72 hp, evil root and pro power max

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

Page 8: Voluntary recall of 72 hp, evil root and pro power max

Conclusion These products are marketed as a dietary supplement for

sexual enhancement. Customers who have these products 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.

Page 9: Voluntary recall of 72 hp, evil root and pro power max

References http://

www.fda.gov/Safety/Recalls/ucm366506.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366524.htm

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

http://www.fda.gov/Safety/Recalls/ucm366506.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
http://www.fda.gov/Safety/Recalls/ucm366506.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
http://www.fda.gov/Safety/Recalls/ucm366506.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366524.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366524.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm366524.htm
Page 10: Voluntary recall of 72 hp, evil root and pro power max

References http://www.nlm.nih.gov/medlineplus/

druginfo/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/

uspi_viagra.pdf


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