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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
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
Read the complete MedWatch 2007 Safety summary, including a link to the
firm's press release, at:
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