FDA warns consumers about health risks of herbal coffee products from Malaysia containing undeclared active pharmaceutical ingredients and milk

Evan Walker
Evan Walker TheMediTary.Com |

[8/21/2017] The U.S. Food and Drug Administration is warning consumers not to drink Longjack Coffee, in addition to other instant coffee products that have been recalled recently – Kopi Jantan Tradisional Natural Herbs Coffee, CaverFlo Coffee, and AMPT Coffee. These products are made in Malaysia, and promoted and sold online for sexual enhancement. 

These products are labeled to contain instant coffee, non-dairy creamer, and other ingredients. However, FDA laboratory analysis confirmed:

  • CaverFlo Coffee and AMPT Coffee contain undeclared sildenafil and tadalafil; 
  • Longjack Coffee and Kopi Jantan Tradisional Natural Herbs Coffee contain undeclared desmethyl carbodenafil, an analogue of sildenafil; and
  • All of these products contain undeclared milk.

Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used for the treatment of erectile dysfunction. 

Although these coffee products are labeled as a “natural” or “herbal” they can cause serious harm. The undeclared active ingredients, sildenafil, tadalafil, and desmethyl carbodenfil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. People who have an allergy or severe sensitivity to milk are at risk of serious or life-threatening allergic reaction if they consume these products.

FDA has received one serious adverse event report related to the use of CaverFlo Coffee.  Consumers should be cautious of other similarly marketed instant coffee products being sold online or in retail outlets for sexual enhancement. 

Health care professionals and consumers are encouraged to report any adverse events or side effects related to the use of these products and other similar products to FDA’s MedWatch Adverse Event Reporting program by:

  • Completing and submitting the report online at MedWatch online voluntary reporting form; or
  • Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.

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SOURCES: fda.gov
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