Not all “natural” remedies are all that “natural” after all

Caverflo Natural Herbal Coffee was introduced to the US market in August 2016 as a natural male enhancement remedy. Packaged in black foil sachets, 25 grams each, Caverflo Natural Herbal Coffee was marketed directly to consumers from a dedicated website However, the maker of the remedy was forced to recall the product from sales in February 2017 following the death of a customer who consumed the beverage. Immediately thereafter, the US food and drug regulating authority established that the product contained chemically synthetized drugs meant for the treatment of male erectile dysfunction.

Caverflo Natural Herbal Coffee Contained Viagra and Cialis ED Drug Ingredients that Could Have Caused Death marketed the coffee as a 100% herbal beverage that contained instant coffee and three Asian herbs – Maca, Tongkat Ali, and Guarana – all growing wild in Malaysia and have allegedly been used by many generations of Asian men to enhance their sexual health.

The website, however, didn't reveal the two active ingredients in the coffee, which happened to be a huge deal because those ingredients can critically interact with nitrate drugs, potentially leading to a patient’s death. Nitrates can be found in some prescription drugs taken by men with high blood pressure, diabetes, high cholesterol, and cardiovascular disease. The two chemically synthetized ingredients found in Caverflo coffee were sildenafil and tadalafil – the active ingredients in the universally approved prescription drugs Viagra and Cialis, respectively, used for the treatment of erectile dysfunction in men.

Although Caverflo beverage was labeled as “herbal” and “natural,” it could cause serious harm. The undeclared active ingredients, sildenafil and tadalafil tend to interact with nitrates found in many popular drugs, such as nitroglycerin, and lead to blood pressure plunging to dangerously low levels. Besides, Caverflo Natural Herbal Coffee also contained undeclared milk. People with an allergy to milk products are at high risk of serious or life-threatening allergic reactions should they ingest dairy-containing products.

It was unclear how the drugs appeared in the coffee, but a source in herbal remedies industry told the Washington Post that he suspected it was from an unclean herbal ingredient, Tongkat Ali. A herb derived from Eurycoma longifolia plant, it is often called “Malaysian ginseng” for its anti-aging and libido-enhancing capabilities. However, Tongkat Ali can be expensive to harvest in industrial-level amounts since it requires uprooting the bulky plants. When the news broke about ED drugs in Caverflo coffee, many fellow producers widely speculated that the producers of the herb might have intentionally mixed in the synthetic Viagra-like drugs to reduce costs.

In any case, the only conclusion from this tragic story is you cannot rely on health products from undetectable produces, no matter how “natural” and “herbal” these products are.

Controlled treatment with sildenafil and tadalafil can be safe and effective

Controlled treatment with sildenafil and tadalafil can be safe and effectivePhosphodiesterase 5 (PDE5) inhibitors represent the most effective way to treat erectile disorders in men by augmenting the body’s normal reaction to stimulation due to increased blood flow to the penile area.

The two types of PDE5 inhibitors (more details about PDE5: that were discovered in Caverflo Natural Herbal Coffee are extensively used for controlled ED treatment. Sildenafil (also known as generic Viagra) usually starts working within 40 minutes and lasts for up to 4 hours, while tadalafil (also known as generic Cialis) starts working faster – within some 30 minutes – and ensures up to 36 hours of erection achievement capabilities. Both drugs require stimulation for erection to happen. All three PDE5 inhibitors have been proved effective in the general population of men with ED.

When used on purpose and under control, the success rates of sildenafil and tadalafil in coping with ED are quite impressive:

  • The success rate of sildenafil was evaluated in a recent flexible-dose clinical study of some 350 patients (mean ED duration in patients: 4.7-5.0 years, mean patient age 59 years;). Some 75% of the patients taking sildenafil stated that their erection was enhanced, as compared to 16% of the patients who were taking placebo.
  • The success rate of tadalafil was evaluated using the data from eleven clinical studies with some 1600 participants in total (ED duration ≥1.0 year for over 90% of patients, mean patient age 56 years). In total, 84% of the patients taking Tadalafil (1050 individuals) admitted that their erection was enhanced, as compared to 33% of study participants taking placebo.

Fatty food might delay the absorption of generic Viagra (sildenafil), but it has almost no effect on the absorption of generic Cialis (tadalafil), so the letter can be taken with no regard to foodstuff. Although pharmacokinetics of both PDE5 inhibitors are not impacted by alcohol, men are recommended to abstain from alcohol, since the consumption of alcohol has been associated with the increased risks of erectile dysfunction.

Clinical studies also showed that the PDE5 inhibitors, such as sildenafil and tadalafil, can be successfully used in ED patients with existing health conditions, such as stable cardiovascular disease, diabetes, or even clinical depression. Both PDE5 drugs in question can be exclusively applied in those cardiovascular disease patients who do not use nitrate drugs, since interaction of Viagra with nitrates can be deadly.

Nitrate therapy is a strict contraindication to PDE5 inhibitor drugs. Combination of nitrates with sildenafil and tadalafil can produce erratic excessive vasodilation, leading to profound drop in blood pressure – and, potentially, to patient’s death. If hypotension occurs, the patient must be placed in the Trendelenburg position (the body is laid flat or supine on the back with the head lower than the feet by 15-30 degrees) and emergency help requested. Revival with intravenous fluids must be initiated as soon as possible.

Sublingual nitrates must not be taken within 24 hours of using sildenafil and within 48 hours of using tadalafil. If a patient has ED and stable angina, a review of the need for nitrates must be carried out before rejecting treatment with PDE5 inhibitors

Because PDE5 inhibitors are largely metabolized via hepatic enzymes by isoform 3A4 of cytochrome P450 (see more): , the inhibitors of this enzyme (e.g. cimetidine, erythromycin, ritonavir, indinavir, ketoconazole, etc.) may decrease clearance of sildenafil and tadalafil.

Sildenafil must be taken with caution by those ED patients who are taking alpha-blockers (doxazosin, prazosin, terazosin, etc.), since concurrent administration might instigate hypotension. Sildenafil should not be taken within 4 hours of taking an alpha-blocker. Tadalafil must not be taken in combination with alpha-blockers.

The side effects profiles of PDE5 inhibitors are similar, with the most common (>1%) side effects, as follows:

  • For sildenafil: flushing, headache, dyspepsia, dizziness, altered vision and nasal congestion.
  • For tadalafil: dyspepsia, headache, myalgia and back pains, flushing, dizziness, nasal congestion.