FDA warns against
“Clalis” P.Naina Mohamed
Pharmacologist
Introduction
The Food and Drug Administration (FDA) is
advising consumers not to purchase or use
Clalis, a product promote...
Possible Mechanism of Action
Clalis
Contains Sildenafil
Inhibition of Phosphodiesterase 5 (PDE 5)
Inhibition of Breakdown ...
Interaction with Nitrates
Undeclared ingredient (Sildenafil)
Interact with prescription drugs like nitrates
(Nitroglycerin...
Other Interactions
Undeclared ingredient (Sildenafil)
Interacts with Alpha adrenergic blockers,
other antihypertensives or...
Conclusion
FDA warns the Consumers should stop using this product
immediately and throw it away.
FDA advises the Consumers...
References
http://www.fda.gov/Drugs/ResourcesForYou/Consume
rs/BuyingUsingMedicineSafely/MedicationHealthFra
ud/ucm359070....
References
 http://www.nlm.nih.gov/medlineplus/
druginfo/meds/a699015.html
 http://www.rxlist.com/viagra-
drug/clinical-...
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Clalis

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FDA warns the consumers not to buy Clalis which contains undeclared ingredient of Sildenafil.

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Clalis

  1. 1. FDA warns against “Clalis” P.Naina Mohamed Pharmacologist
  2. 2. Introduction The Food and Drug Administration (FDA) is advising consumers not to purchase or use Clalis, a product promoted and sold for sexual enhancement on various websites, including www.hardmenstore.com1, and in some retail stores, on 28th June 2013. FDA laboratory analysis confirmed that Clalis contains sildenafil, the active ingredient of Viagra.
  3. 3. Possible Mechanism of Action Clalis Contains 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
  4. 4. Interaction with Nitrates Undeclared 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
  5. 5. Other Interactions Undeclared ingredient (Sildenafil) Interacts with Alpha adrenergic blockers, other antihypertensives or CYP3A4 enzyme inhibitors like Ketoconazole, Erythromycin, Ritonavir Lower blood pressure Hypotension
  6. 6. 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.
  7. 7. References http://www.fda.gov/Drugs/ResourcesForYou/Consume rs/BuyingUsingMedicineSafely/MedicationHealthFra ud/ucm359070.htm?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
  8. 8. References  http://www.nlm.nih.gov/medlineplus/ druginfo/meds/a699015.html  http://www.rxlist.com/viagra- drug/clinical-pharmacology.htm  http://www.medicinenet.com/sildenaf il/article.htm  http://www.pfizer.com/files/products/ uspi_viagra.pdf

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