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The US Food and Drug Administration sent Thursday a letter of warning to the Chinese company HelloCig Electronic Tech for selling two e-liquids containing drugs for erectile dysfunction.
No prescription drug is approved to be inhaled in part because no studies have been conducted on the risks, say the authorities, making this operation illegal.
They warn users that the active ingredients tadalafil and sildenafil can cause a turbocharge of drugs for high blood pressure, thus dangerously lowering blood pressure.
Dr. Premal Patel, a urologist at the University of Miami, warned that heart medications are common in men with erectile dysfunction.
"We are learning more and more because erectile dysfunction could be a source of heart problems in the future," Dr. Patel told DailyMail.com.
& # 39; The same blood vessels supplying blood to the heart [provide blood to] the penis.
As a urologist, he says, it's also a job to check the patients' heart health and to know that drugs like Cialis or Viagra "have side effects if you take them with medications ".
"So putting them in a vape … especially if it's not stated, it's risky," he says.
One of the marketed liquids, E-Cialis HelloCig E-Liquid, contains both tadalafil and sildenafil. Another product, E-Rimonabant, contains sildenafil and is marketed with the image of an anti-obesity drug that is not legal in the United States.
With regard to the actual impact of tadalafil vapotage and sildenafil, it's unexplored territory.
They work by dilating the blood vessels to improve blood flow to the penis; they can also be prescribed to lower blood pressure in the lungs. But the drugs have been designed to be swallowed.
In the early 2000s, there was a trial of a nasal spray erectile dysfunction drug produced by a New Jersey pharmaceutical company. It would have become the first drug against erectile dysfunction to act on the central nervous system. However, they did not go beyond the first experiences.
Fifteen years later, pills are the only approved form for erectile dysfunction drugs.
"All the studies ever done on [these drugs] are from an oral point of view, so we do not know what it would be like to inhale them, "says Dr. Patel.
Another concern is that e-cigarettes allow users to ingest high concentrations of substances, be it nicotine or vitamins, very quickly.
The warning against HelloCig comes hours after a report by the California Department of Food and Agriculture revealed that hundreds of over-the-counter supplements contained active drugs, such as than Viagra.
The report states that the FDA is aware of these violations of the rules, but for obscure reasons, it is not reprehensible.
With regard to electronic cigarettes, however, the agency does not miss any opportunity.
FDA Commissioner Scott Gottlieb declared war on Juul. He launched a surprise raid at the company's headquarters earlier this month to capture information about how they market their products to children.
They warn that the product, which is touted as a way to quit smoking, encourages people to smoke, especially teens, with attractive aromas for e-liquids like cinnamon and cotton candy.
Viagra, however, is an entirely different problem that they have not faced, which could have deadly ramifications – and they are trying to eliminate the egg.
"There are no e-liquid products approved to contain prescription drugs or any other medication requiring the supervision of a physician," said FDA Commissioner Scott Gottlieb, MD.
"Prescription drugs are carefully evaluated and labeled to reflect the risks of the drugs and their potential interactions with other drugs, and vaping of the drug's active ingredients is an ineffective and potentially dangerous delivery route.
"There are no e-liquids containing prescription drugs that have been proven safe or effective by this route of administration.
"This action is part of the FDA's broader efforts to regulate the safety of vaping products and to combat misleading claims and illegal and dangerous electronic liquids that are likely to attract young people or consumers." put consumers at risk. "
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