RhinoMax Recalled

March 19, 2007
Don't know how many of you would buy a medicine from a company named Cosmos Trading (no offense to the company, which appears to have cooperated fully with FDA, but it doesn't sound like a dedicated drug supplier)but just received an FDA notice of a recall of a supplement called RhinoMax, which contained an undeclared ingredient, aminotadalafil, which can react with nitrates from other drugs (like nitroglyercin) to lower blood pressure to dangerous levels. Silly me, from the "rhino" I thought it was a nasal decongestant, but, it is instead a treatment for that killer disease, "ED."  Below, the notice from FDA including a link to the full safety report. How can one avoid declaring an active ingredient like that?  All of which points to the need for far better testing of raw materials, and use of better technology, including PAT. Lives are at stake here. MedWatch - The FDA Safety Information and Adverse Event Reporting Program Cosmos Trading, Inc. and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max (Rhino V Max) in 5-tablet boxes or 15-tablet boxes. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil 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. Consumers who have Rhino Max (Rhino V Max) in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. Read the complete MedWatch 2007 Safety summary, including a link to the firm's press release, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rhino _________________________________________________________________ To ensure delivery of these timely alerts to your in-box and prevent rejection of the notice by a spam filter, please add our MedWatch address, [email protected], to your address book. Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process.  They can learn more and subscribe to the e-list at http://www.fda.gov/medwatch.
Don't know how many of you would buy a medicine from a company named Cosmos Trading (no offense to the company, which appears to have cooperated fully with FDA, but it doesn't sound like a dedicated drug supplier)but just received an FDA notice of a recall of a supplement called RhinoMax, which contained an undeclared ingredient, aminotadalafil, which can react with nitrates from other drugs (like nitroglyercin) to lower blood pressure to dangerous levels. Silly me, from the "rhino" I thought it was a nasal decongestant, but, it is instead a treatment for that killer disease, "ED."  Below, the notice from FDA including a link to the full safety report. How can one avoid declaring an active ingredient like that?  All of which points to the need for far better testing of raw materials, and use of better technology, including PAT. Lives are at stake here. MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramCosmos Trading, Inc. and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max (Rhino V Max) in 5-tablet boxes or 15-tablet boxes. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil 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. Consumers who have Rhino Max (Rhino V Max) in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.Read the complete MedWatch 2007 Safety summary, including a link to the firm's press release, at:http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rhino_________________________________________________________________To ensure delivery of these timely alerts to your in-box and prevent rejection of the notice by a spam filter, please add our MedWatch address, [email protected], to your address book.Thank you for using FDA MedWatch as a trusted source for timely safety information on drugs, devices and diagnostics regulated by the U.S. Food and Drug Administration. If you find this e-mail notification helpful, please consider telling colleagues and friends about MedWatch and this e-mail notification process.  They can learn more and subscribe to the e-list at http://www.fda.gov/medwatch.
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