Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Enterprise Technology
  • Contract Manufacturing
  • R&D 100 Awards

Potentially Dangerous Drug Ingredients Spark New FDA Warning

By U.S Food and Drug Administration | November 29, 2018

The U.S. Food and Drug Administration is warning consumers not to purchase or use Rhino male enhancement products, due to a recent rise in reported health issues. Since 2007, the FDA has identified more than 25 products marketed with variations of the name “Rhino” that contained hidden drug ingredient(s).

The products continue to be sold at gas stations and convenience stores, as well as on websites such as eBay and Amazon. More recently, the unapproved products have been discovered in international mail shipments to the U.S. They often are sold in single-serving package sizes. Rhino products include names such as Platinum Rhino 25000, Krazzy Rhino 25000, and Gold Rhino 25000.

The FDA has received reports of people experiencing chest pain, severe headaches, and prolonged erections after taking a Rhino product that led to surgical intervention and hospitalization due to extreme drops in blood pressure.

Since 2015, the FDA’s Office of Criminal Investigations has been investigating a South Korean national living in the Los Angeles area for smuggling raw materials, producing Rhino capsules and distributing the misbranded drug products throughout the U.S. The case led to an indictment, which is being prosecuted by the U.S. Department of Justice. The FDA continues to pursue regulatory and criminal actions against those who violate federal law. 

The FDA has posted warnings that these Rhino products contain undeclared ingredients that are the same as or structurally similar to active ingredients found in FDA-approved prescription drugs used to treat erectile dysfunction. For example, the FDA has identified various Rhino products containing sildenafil and/or tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively.

These undeclared ingredients are phosphodiesterase type-5 (PDE-5) inhibitors, which can be associated with significant safety issues and the risk of serious adverse events. For example, they may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

(Source: U.S. Food and Drug Administration)

Related Articles Read More >

HIV
Injectable anti-HIV therapies could see strong growth
Pfizer-BioNTech vaccine
Pfizer vaccine stable at standard freezer temps, effective with single dose
coronavirus COVID-19 Pfizer
4 things to keep in mind as COVID-19 vaccination efforts scale
Johnson & Johnson
J&J CEO says getting a COVID-19 vaccine could be an annual ritual for years

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup

R&D Twitter

Tweets by @RandDWorld
Pharmaceutical Processing World
  • Enews Signup
  • Contact Us
  • About Us
  • R&D World
  • DeviceTalks
  • Drug Discovery & Development
  • Drug Delivery Business News
  • MassDevice
  • Medical Design Sourcing

Copyright © 2021 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Enterprise Technology
  • Contract Manufacturing
  • R&D 100 Awards