Warning letters were issued by the U.S. Food and Drug Administration (FDA) to 4 companies selling honey-based products containing undisclosed ingredients in their products, including active drug ingredients such as tadalafil and sildenafil.

Laboratory analysis performed by the FDA found hidden tadalafil and sildenafil in honey-based products from Thirstyrun LLC (also known as US Royal Honey LLC), MKS Enterprise LLC, Shopaax.com and 1am USA Incorporated dba Pleasure Products USA. Tadalafil and sildenafil are classified as phosphodiesterase (PDE) inhibitors. These drugs increase blood flow to certain areas of the body and are usually used to treat erectile dysfunction.

Erectile dysfunction medications are known to interact with other prescription drugs such as nitrates. People with diabetes, high blood pressure, high cholesterol, or heart disease are often prescribed nitrates to help widen (dilate) their blood vessels. This makes blood flow through your vessels easier. Concomitant use of ED medications may cause a sudden drop in blood pressure to dangerous levels.

If you or someone you know thinks that a product, they took may have caused a reaction or illness, they should immediately stop using the product and contact their health care provider. The FDA encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.