A hand cupping an illustration of blue bills

Hey, here’s a great idea… make it possible for people to get Viagra over the counter! Over-the-counter (OTC) sales would help so many men who are too embarrassed to discuss ED with their doctors.

Viagra, of course, is the “little blue pill” that treats erectile dysfunction (ED). Derived from a research study for a blood pressure medication, it wasn’t good enough to become a standalone hypertension drug, but it did produce the humorous anecdote about so many of the men participating in the study snickering about all the erections they were having. And the rest, as they say, is history. It wasn’t long before other ED drugs hit the market to cash in on the lucrative market, filling the vacuum created by flaccidity. Vardenafil (Levitra) and tadalafil (Cialis) soon joined the ranks of options, tweaking the properties and earning patents in their own right.

With Pfizer’s own patent on sildenafil (generic for Viagra) set to run out in 2020 and plenty enough business for everyone, the floodgates would open faster than the nitric oxide-opened spongy tissue in the penis. Men and women living together in sexual fulfilment. More erections, more happy couples, more sex. With apologies to Aldous Huxley, it would be a Brave New World.

Whatever could go wrong!

 

What could go wrong? Grapefruit juice enthusiasts (and others) beware!

There isn’t just one fly in the ointment—there are several:

Anatomical distortion

Men with abnormal scarring in the penis from injury (Peyronie’s disease) may extend the injury if blood is forced into tissues.

 

Clotting disorders

there may be decreased clotting ability with sildenafil, increasing the risk of strokes or hemorrhage.

 

Priapism

This is a painful, prolonged (>4 hours) erection in which the irony is that such engorgement actually decreases blood flow and oxygenation to tissues in the penis, endangering the tissue. Priapism may occur for unknown reasons, but there are many known causes of priapism even without Viagra, such as sickle cell anemia. Pile Viagra on top of a condition known to risk priapism is reckless and dangerous.

 

Liver and kidney disease

Because the liver and kidneys detoxify substances and eliminate them, a buildup of sildenafil can occur if either of these aren’t at peak performance in clearing it normally.

 

Interaction with other medications

Besides the sudden blood pressure crash seen with nitrates used in hypertension, another situation—a buildup in the concentrations of sildenafil in the body—can occur when some drugs interfere with sildenafil’s metabolism, such as some common antibiotics and antifungal medications. The newer hepatitis antivirals can do this as well. And grapefruit juice, too. Grapefruit juice? Really? Really!

 

Cardiovascular disease

This, of course, is the famous one. Sudden cardiovascular collapse by those on other blood pressure-lowering medications is the 800-pound gorilla. And gorillas can be dangerous. But there may be a sneakier risk here than what it seems to be. There are some men in whom sex alone might put them in cardiac danger, and taking Viagra might allow the opportunity to test out their hearts with sex. Collapse and death may not be related to an interaction between Viagra and nitrates, but due to exertion via sex. In these men Viagra didn’t make death more likely, but made sex more likely, which made death more likely.

 

What’s the point?

The point is this: Many conditions mix badly with Viagra, but used correctly, under professional supervision and counseling, it’s not out of the question. Take away the healthcare professional (prescriber as gatekeeper), and everyone’s on their own. Smart men, stupid men, cautious men, reckless men, and—carrying the baggage of the caveats described above—horny men. Being able to buy Viagra with only a wink-and-a-smile at the pharmacy simply will expose more men to danger they won’t even see coming.

 

Is Viagra going to be on those 1-800-TERRIBLEDRUG lawyer commercials?

Viagra is not a terrible drug; it is a wonderful drug.

It has taken the relationship-wrecking curse of erectile dysfunction out of the closet and into therapeutic redemption. Expressing intimacy physically is very important—even crucial—in a relationship, and ED was the emergency for which there was no emergency room. Now, even with medical conditions, it can be safely monitored when necessary, but withheld when indicated.

 

How to keep Viagra wonderful

The thing that keeps it a wonderful drug is the prescription, because without that, the statistics of mortality will be based on the lowest common denominator of judgement, fueled with the high octane frenzy of the sex drive:

If a drug can be both wonderful—usually—and dangerous—sometimes, taking away the expertise in its administration is likely to make it dangerous often.

 

But seeing a doctor just to get Viagra is a drag

On first blush, this seems like a valid complaint. Whiny, but valid. Appointments, traffic, parking, time off from work with an embarrassing doctor’s excuse, co-pays, and—not to mention—hating going to the doctor—all earn a groan at the prospect. However, consider this:

Erectile dysfunction is a problem with circulation, and circulation is not exclusive to the penis. (Humorous aside: sometimes thinking is, but that’s another story.) Because the penis has no circulation exclusivity, if there are circulation problems in the penis, there are certainly circulation problems everywhere else. This means that a man with circulation problems needs to be seeing a doctor anyway. The penis doesn’t cry wolf. It’s a valuable alarm signal that trouble is lurking in the cardiovascular system. And while someone is seeing a doctor, anyway…

That’s when an incidental prescription for Viagra can be requested. But it is not incidental: it is written with years of medical training and experience behind the pen stroke and signature.

 

What about another type of OTC? What about herbal Viagra? What about the “All Natural” remedies?

If the above convincingly lays out the case for keeping Viagra prescription-only, what about all these things that are advertised to be just as good? “All natural”? Herbal?

No prescriptions needed for those, but there are two considerations here:

Are they fakes? Or,

Are they for real?

 

If they’re fake, that ends the discussion. One might as well ask for fairy dust. The worst thing that can happen is to foolishly lose one’s hard-earned money in the search for a hard-earned erection.

 

But what if they are the real thing?

They’re not just like drinking a Coke. It they’re for real, this becomes even more dangerous than getting Viagra without a prescription. After all, what’s in Viagra is a known. What’s in the “all natural,” herbal replacement is unknown. Just because it’s “all natural” doesn’t mean it’s all safe. Arsenic is natural. Many things are natural but very bad for us—lead, background radon radiation, road rage, etc. Calling something “all natural” isn’t green, corporate responsibility, but mere marketing—a sucker punch for the buzzword consumer.

The main problem with herbal and “natural” supplements is that they escape regulation by the FDA: the ingredients don’t have to be listed; the efficacy does not have to be proven; and the risk does not have to jeopardize the bottom line of the supplier.

Even assuming that it is what it claims to be, “all natural” nitrate ingredients or nitrate-like compounds like sildenafil are there to pose the same risk OTC Viagra would create. Your healthcare professional becomes the health food store clerk. Not exactly a medical degree.

Erectile dysfunction means circulatory dysfunction

Whether it’s OTC Viagra, herbal and natural supplements for ED, or even borrowing a Viagra from a friend’s stash, the dangers are the same. Erectile dysfunction means circulatory dysfunction—cardiovascular disease that merits a doctor’s evaluation. If not cardiovascular, it could mean diabetes, high cholesterol, or metabolic syndrome. Therefore, trying to treat erectile dysfunction oneself without the proper cardiovascular workup is as risky as unprotected sex with a stranger.

 

 

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Resources:

  • European Medicines Agency. Questions and answers on the withdrawal of the application for a hange to the marketing authroisation for Viagra. 2008. London. (http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2009/12/WC500018459.pdf.)
  • http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000202/wapp/post-authorisation/human_wapp_000020.jsp&mid=WC0b01ac058001d128.
  • Rampin O, Giuliano F. Central control of the cardiovascular and erection systems: possible mechanisms and interactions. Am J Cardiol 2000; 86:19F.
  • DeBusk RF. Evaluating the cardiovascular tolerance for sex. Am J Cardiol 2000; 86:51F.
  • Möller J, Ahlbom A, Hulting J, et al. Sexual activity as a trigger of myocardial infarction. A case-crossover analysis in the Stockholm Heart Epidemiology Programme (SHEEP). Heart 2001; 86:387.
  • Ishikura F, Beppu S, Hamada T, et al. Effects of sildenafil citrate (Viagra) combined with nitrate on the heart. Circulation 2000; 102:2516.
  • https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm465024.htm.


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