Americans are vaping Viagra - and regulators are swooping in to kill the mood.

October 15, 2018  13:45

The US Food and Drug Administration issued a warning letter to China-based HelloCig Electronic Tech Company on Thursday for selling two e-liquids that contain erectile dysfunction drugs.

No prescription drug is approved to be inhaled partly because no studies have been conducted on the risks, officials say, making this operation illegal.

They warn users that the active ingredients tadalafil and sildenafil can turbocharge hypertension medications, driving down blood pressure dangerously low.
Dr Premal Patel, a urologist at the University of Miami, warns that is a major concern because heart medications are common among men with erectile dysfunction problems.
'We are learning more and more than erectile dysfunction could be a harboring of cardiac problems in the future,' Dr Patel told DailyMail.com.

'The same blood vessels providing blood to the heart [provide blood to] the penis.'
As a urologist, he says, it's part of the job to check patients' heart health too, and to be aware that drugs like Cialis or Viagra 'have side effects if you take them with medication.'
'So putting them in a vape... especially if it's not declared, it's risky,' he says.
One of the marketed liquids, E-Cialis HelloCig E-Liquid, contains both tadalafil and sildenafil. Another one, E-Rimonabant, contains sildenafil and is marketed with a picture of an anti-obesity drug that is not legal in the US.

When it comes to the actual impact of vaping tadalafil and sildenafil, it's uncharted territory.
They work by dilating blood vessels to improve blood flow to the penis; they can also be prescribed to lower blood pressure in the lungs. But the drugs were designed to be swallowed.

There was one trial in the early 2000s for an erectile dysfunction drug delivered via nasal spray, produced by a New Jersey pharmaceutical company. It would have become the first erectile dysfunction drug to act on the central nervous system. However, they didn't make it past early experiments.
Fifteen years later, pills are the only approved form for ED drugs.

'All the studies ever done on [these drugs] are from an oral perspective so we don't know what it would do to inhale them,' Dr Patel explains.

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 hundreds of over-the-counter supplements contain active drugs - such as Viagra.

The report said that the FDA is aware of these rule-breakers but, for unclear reasons, isn't cracking down.

When it comes to e-cigarettes, however, the agency misses no opportunity.

FDA Commissioner Scott Gottlieb, MD, declared war on Juul, issuing a surprise raid on the company's headquarters earlier this month to seize information on how they market their product to children.

They warn the product, which are promoted as ways for smokers to quit, is luring people into smoking, particularly teenagers, with attractive e-liquid flavorings like cinnamon and candy floss.

Viagra, however, is a whole other issue they hadn't confronted, which could have mortal ramifications - and they are trying to nip in the bud.

'There are no e-liquid products approved to contain prescription drugs or any other medications that require a doctor's supervision,' said FDA Commissioner Scott Gottlieb, MD.

'Prescription drugs are carefully evaluated and labeled to reflect the risks of the medications and their potential interactions with other medicines, and vaping active drug ingredients is an ineffective route of delivery and can be dangerous.

'There are no e-liquids that contain prescription drugs that have been proven safe or effective through this route of administration.

'This action is part of FDA's broader effort to regulate the safety of vaping products, and crack down on misleading claims and illegal and dangerous e-liquids that may entice youth or put consumers at risk.'

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