Two e-cigarette liquids contain undisclosed prescription drugs that treat erectile dysfunction and should not be used, the Food and Drug Administration (FDA) said in a warning Wednesday.
The two HelloCig e-liquids contain tadalafil and sildenafil, the main ingredients in two of the most popular male enhancement drugs on the market, the FDA said. “These FDA-approved prescription drugs are not approved for inclusion in e-liquid products sold over the counter and are therefore being sold illegally.
The drugs may cause negative interactions with other prescription drugs leading to dangerously low blood pressure. People who take nitrates for issues like diabetes, high blood pressure, high cholesterol or heart disease are among those at risk of experiencing these side effects. HelloCig has ignored FDA recommendations to recall the products, officials said.
By not properly labeling the e-liquids, the agency said, the company was not providing adequate warnings for the protection of users, specifically anyone with erectile dysfunction, high blood pressure, diabetes, high cholesterol or heart disease who take nitrates to manage their condition.
“These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels,” .
A lab analysis found both sildenafil and tadalafil in E-Cialis HelloCig E-Liquid and sildenafil in E-Rimonabant HelloCig E-Liquid, both sold by Shanghai-based HelloCig Electronic Technology Co. Ltd.
The company has not responded to a request for comment.
Although no adverse events have been reported to the agency, all consumers should stop using the products immediately, the FDA said, and anyone who experiences side effects should report them to the FDA’s MedWatch Adverse Event Reporting program.
The FDA says it sent a warning letter to HelloCig in October, citing a number of concerns about illegal marketing claims. HelloCig was misbranding and selling its products in the United States as an “FDA approved product with FDA,” in violation of federal rules.
“FDA recently warned HelloCig of these issues and contacted the company several times to recommend they recall these products due to the risks to consumers. However, HelloCig has not responded to the agency’s recommendation,” the agency said in its warning.