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Man consulting a pharmacist.

Will Viagra Ever Be Available Over the Counter in the U.S.?

With Viagra available over the counter in the United Kingdom since the spring of 2018, it’s hardly surprising that U.S. market observers are questioning whether a similar move is likely in the United States.

In a May 2018 article posted at Forbes.com, John LaMattina suggests that it’s possible that Food and Drug Administration Commissioner Scott Gottlieb might look favorably on a proposal to take Viagra OTC. But such an approval is hardly a sure thing.

Drugs That Are Now OTC in the US

In an earlier Forbes.com article, LaMattina, former president of Pfizer Global Research and Development, noted that a number of medications, formerly available only by prescription, have made the transition to OTC status over the past few decades. Among such drugs are Prilosec, a proton pump inhibitor, and Zantac, a histamine H2 antagonist, both prescribed to treat heartburn and prevent ulcers; the anti-allergy medications Claritin and Zyrtec; and the painkillers ibuprofen and naproxen.

These drugs that made the switch from prescription-only to OTC all have something in common: They all treat readily discernible symptoms and have relatively few serious side effects.

Lipitor Initiative Failed

Less successful, wrote LaMattina, was Pfizer’s attempt to make another of its popular brand-name drugs available without a prescription. That case involved Lipitor, a statin drug prescribed to lower elevated blood levels of cholesterol and triglycerides. High cholesterol/triglycerides is usually asymptomatic and is a condition detected only by laboratory testing of blood lipid levels.

To advance its case for taking Lipitor OTC, Pfizer petitioned the FDA for permission to conduct a phase 3 clinical trial to determine whether consumers taking the OTC drug would voluntarily get blood tests to see if the medication was working. Sadly, the tests showed that patient compliance when it came to blood tests would be disappointingly poor. Pfizer and the FDA jointly called an end to the OTC Lipitor experiment.

How Viagra Compares

Like some of the medications that have won OTC approval, Viagra treats symptoms that are readily apparent, namely an inability to get and/or keep an erection suitable for intercourse. It wouldn’t take long for a prospective user to determine whether the drug is working or not.

Also on the plus side, Viagra’s most common side effects are mild and generally tend to subside upon continued use of the drug.

On the downside, erectile dysfunction, the disorder targeted by Viagra, can be caused by a wide array of factors, some of them underlying health conditions that could eventually prove life-threatening. For that reason, some medical professionals would like to see Viagra retain its prescription-only status. That way, patients would have to consult doctors who could presumably detect the presence of such underlying medical conditions and treat them as needed.

Urologist Sees Both Sides

Urologist Philip Werthman, M.D., director of the Center for Male Reproductive Medicine and Vasectomy Reversal in Los Angeles, told Healthline.com that he sees both sides of the debate about Viagra OTC. However, in the interest of detecting serious underlying illness that’s causing ED symptoms, Werthman said he’d like to see Viagra kept “in the hands of doctors.”

Werthman also noted that the U.K. experiment with OTC Viagra will produce evidence that can hopefully inform a future decision about the matter in this country.

No matter which side of the debate one takes, it seems likely that it will be a while before Viagra becomes available without a prescription in the United States.

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