“Pink Viagra” (Which Is Actually Purple) Is Not Selling Well at All

By Sondra Forsyth

Back in June of 2015 here at thirdAGE, we gave you advance warning that the female libido booster slated for an approval vote by the FDA was costly and risky. Then in August of 2015, we let you know that the pill — dubbed “Pink Viagra” and bearing the brand name Addyi — had in fact been approved in spite of numerous objections from the medical community.

Not long after the approval of Addyi, Valeant Pharmaceuticals acquired the rights to the drug from Sprout Pharmaceuticals for a whopping $1 billion. Yet sales of the medication got off to a very slow start. Then in January 10^th 2016 update in the Pittsburgh Post-Gazette by Adam Smeltz reported that only about 1,000 prescriptions were filled in the drug’s first two months on the U.S. market. Smeltz quoted Beth A. Prairie, a midlife-gynecology specialist at West Penn Hospital in Bloomfield PA, as saying, “Women are just smarter than the drug company thought.” She added that the drug has proven “very expensive and not very effective.”

In the same vein, a doctor writing on KevinMD pointed out that the burden of making sure patients don’t drink any alcohol while on Addyi falls to physicians – a task that is obviously not easy to accomplish. Drinking alcohol while taking the so-called “little pink pill” — which is actually a purple capsule — greatly increases the risk of fainting and subsequent injuries. Perhaps most important, though, is the fact that Addyi doesn’t do much to increase desire. And as a refresher, the moniker Pink Viagra is a misnomer. Viagra, the blue pill for male erectile dysfunction, works by helping to create an erection but it does not increase men’s desire. If a guy isn’t in the mood, Viagra won’t help at all. As for Addyi, it doesn’t purport to create any physical changes in women. The only claim is that it will make women want sex, but report after report says it rarely if ever fulfills the promise.

Given all of that, is there any solution to a desire dip – especially for post-menopausal women? Our trusted medical contributor here a thirdAge, Marie Savard M.D., says that that testosterone — while not for everyone — is the only true desire booster for women. Here is her article on that subject.

And while we’re on the subject of escalating the sex drive, be sure to warn the men in your life that over-the-counter remedies mostly don’t work and can be harmful. That is the finding of a January 11^th 2016 study done at the Wake Forest Baptist Medical Center in Winston-Salem NC. The researchers report that most top-selling OTC sexual treatments for men are unproven, and that some could be toxic. The results were published online ahead of print in the Journal of Sexual Medicine.

The release quotes Ryan Terlecki, M.D., associate professor of urology and senior author, as saying, “While certain natural supplements we reviewed show promise for improving mild sexual dysfunction, they lack robust human evidence. In addition, because of concerns that some products are impure or weak, we do not routinely recommend these products to our patients.”

The release went on to say that for some products, there is no scientific evidence to support claims that can positively impact erectile function, libido and sexual performance. Perhaps most troubling, some products that are advertised as being “natural,” contain traces of phosphodiesterase-5-inhibitors (PDE5Is), the same class of medication that includes prescription drugs such as Viagra, used to treat erectile dysfunction. One study revealed that 81 percent of tested samples of over-the-counter products purchased in the U.S. and Asia contained PDE5Is.

“PDE5Is cannot yet be legally sold over the counter in this country,” said Terlecki. “Men who use these medications without a physician’s supervision run the risk of taking them inappropriately. Patients with advanced heart disease, for example, or who take nitrates, such as nitroglycerin, should not use PDE5Is as it may cause an unsafe drop in blood pressure. Likewise, men with severe liver impairment or end-stage kidney disease requiring dialysis should avoid these products.”

In addition, Terlecki said, men with enlarged prostates who take medications such as Flomax (tamsulosin), terazosin or doxazosin need to know how to time the dosing of the two medications to avoid causing dizziness and potential falls, which may result in fractures.

An estimated 40 to 70 percent of men experience some form of sexual dysfunction during their lives. Due to concern regarding costs of prescription drugs, or embarrassment over discussing sexual concerns with their physicians, some men turn to over-the-counter products. According to a recent nationwide survey, 50 percent of respondents reported using dietary supplements for a variety of conditions.

“There is a dizzying array of formulations available and the health effects of nutraceuticals are often confusing to patients and medical practitioners alike,” Terlecki said. “We reviewed the current evidence available for each of the ingredients in top-selling men’s health products to provide urologists with a guide they could use to counsel their patients.

“Patients are paying more than $5 per day to take products with no proven effectiveness,” he said. Products included in the survey ranged in cost from 83 cents to $5.77 per day.

In addition to the lack of scientific evidence for some products, Terlecki noted that purity is also a concern. Because dietary supplements are currently classified as foods, rather than drugs, it is the manufacturers themselves who are largely responsible for ensuring the safety, purity and efficacy of the products. Four major retailers have been targeted by the New York attorney general for selling misleading supplements.

Below, the authors summarize some of the results of an extensive literature search for ingredients in top-selling products:

DHEA seems relatively safe as the data does not show a significant impact on hormone levels. The data is weak to suggest a benefit.

Fenugreek is seen in about a third of the top-selling men’s health supplements. One study noted a benefit in terms of improving sexual arousal and orgasm, as well as muscle strength, energy and well-being. There were no adverse events reported in that study and other studies also show this to be a safe supplement.

Ginkgo Biloba has been marketed to treat numerous conditions. There is no convincing data to support its use in men with erectile dysfunction. It can cause headaches, seizures and significant bleeding, especially if patients are taking Coumadin.

Ginseng is the most common ingredient in top selling men’s health supplements. It can cause headache, upset stomach, constipation, rash, insomnia and can lower blood sugar (caution in diabetics).

Horny Goat Weed is generally safe with rare reports of toxicity (fast heart rate and hypomania). There is no evidence in humans of benefit for sexual function.

L-arginine is the most common amino acid seen in men’s health supplements, also in about a third of top sellers. It has the theoretical potential to improve erectile function in some patients and seems relatively safe. It has been associated, however with a drop in blood pressure, but without a significant change in heart rate.

Maca is the most common vegetable among top selling men’s health supplements. In animal research, use of maca was associated with increased sexual behavior. There have been rare reports of toxicity, such as mild increase in liver enzymes and blood pressure.

Tribulus: No evidence of benefit in humans. Two reports of liver and kidney toxicity in young men taking high doses.

Yohimbine has shown promise for improving male sexual function in some studies.

This drug has been used for a long time. It can cause hypertension, headache, agitation, insomnia and sweating.

Zinc appears to be safe, but there is no evidence of benefit in normal individuals. Zinc deficiency is very rare in the U.S.

So now you know. Maybe everybody is best off relying on time-honored ways to up the romance quotient such as hot tubs, cuddling in front of crackling fire, sharing candlelight dinners, eating oysters, and enjoying some chocolate. Whether these purported aphrodisiacs work or not is still questionable, but they stand to make life more pleasurable — and that can’t hurt!