FDA Warning on ‘Herbal Viagra’ & Lamar Odom’s Collapse

October 20, 2015

Last week former NBA star Lamar Odom was hospitalized when he was found unconscious in a Las Vegas

What is Reload?

Reload, also referred to as “herbal Viagra” or a “natural” product, is a “supplement” that is promoted and sold for sexual enhancement. Because it is technically a “supplement,” Reload and similar sexual enhancement products are not subject to the same safety regulations and standards as prescription and over-the-counter drugs.

Many of these types of “natural” sexual enhancement products are manufactured overseas and have been found to contain various ingredients that are not listed on the label and that have the potential to be extremely dangerous to certain users when not being monitored by a healthcare professional.

FDA Warning the Public of Safety Concerns of Reload & Similar Products…

During a laboratory analysis conducted by FDA, it was confirmed that Reload contains sildenafil. Sildenafil is the active ingredient in the FDA-approved prescription drug Viagra®. Used to treat erectile dysfunction (ED), sildenafil can interact dangerously with other drugs, such as medications for heart disease. On June 10, 2013, following its analysis, FDA issued a public notification advising consumers not to purchase or use Reload. In this notification, FDA warned consumers to stop using the product immediately and throw it away. The Agency also advised that “consumers who have experienced any negative side effects should consult a health care professional as soon as possible,” stating that the “undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.”

In addition to this warning, FDA has published various warnings and notices regarding these types of enhancement “supplements,” where it informed the public about the fraudulent claims of various products being falsely marketed as “dietary supplements” or “foods.” In a consumer update published on October 1st of this year, the Agency announced nearly 300 of these types of products that contain undisclosed ingredients, which have been identified through lab testing.

Recent Press Attention

Although the FDA has warned consumers about the risks associated with these dangerous substances for years, the recent collapse of Lamar Odom has cast a spotlight on the issue. On Tuesday, October 13, the former Lakers basketball player was found unconscious with white fluid coming from his mouth and blood coming from his nose.

Due to various other circumstances at play and substances that were allegedly consumed by Odom, it cannot be said with certainty that the excessive consumption of Reload was the cause of the star’s collapse. However, it certainly helps draw attention to the product’s extremely dangerous side effects. After creating a mainstreamed awareness about the dangers associated with this type of substance, we can only hope that the result will be a diminished use of this and other equally risky products.

The key take away from this issue is that the lack of regulatory oversight on certain types of products can be problematic. If you manufacture or sell a dietary supplement, it is wise to know the exact constituents in that product. The labeling should really reflect this knowledge and should inform consumers of relevant risks.

If you are interested in discussing this or any other subject further, please contact us. And of course, we wish Mr. Odom a full recovery.

TAGS:

July 26, 2016

FDA Warns Consumers of Hidden Drug Ingredients in Certain Xcelerated Weight Loss Products

On Friday, July 22nd , the FDA published three public notifications warning consumers of hidden drug ingredients that are present in various Xcelerated Weight Loss products. Two of the company’s...

August 16, 2016

FDA Warns Consumers of Numerous Products Containing Hidden Drug Ingredients

On August 9, 2016, the FDA issued five public notifications advising consumers not to purchase or use a number of products, including: Citrus’ Fit Adelgazantes R-II Boss-Rhino Gold X-tra Strength...

January 30, 2012

Citing the IIG as Evidence of Ingredient Safety Comes with Caveats

It has become common practice in developing drug formulations to consult the FDA’s Inactive Ingredient Guide (IIG) to obtain information on "acceptable levels" of excipients used in previously...