It’s is the third time this year the FDA has identified a “natural” product sold via the Internet for the treatment of impotence (erectile dysfunction) that was adulterated with the prescription drug tadalafil (Cialis).

Earlier recalls included V-Max and Rhino Max, and Liviro3.

It’s a neat little trick. Promote and sell a “natural” sexual enhancement product over the Internet. Add an unknown quantity of a drug proven to be effective. But don’t tell anybody you did it. When you’re found out, you simply announce a recall of the product.

How could you be expected to know?

To the casual consumer it sounds like a great way to get sexual enhancement without the bother of a doctor’s visit.

Here’s what your risk.

• Dyspepsia
• Back pain
• Myalgia
• Nasal congestion
• Flushing
• Limb pain
• Change in color vision

Less common, but more significant.

• Body as a whole: asthenia, face edema, fatigue, pain
• Cardiovascular: angina pectoris, chest pain, hypotension, hypertension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia
• Digestive: abnormal liver function tests, diarrhea, dry mouth, dysphagia, esophagitis, gastroesophageal reflux, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting
• Musculoskeletal: arthralgia, neck pain
• Nervous: dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo
• Respiratory: dyspnea, epistaxis, pharyngitis
• Skin and Appendages: pruritus, rash, sweating
• Ophthalmologic: blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids
• Urogenital: erection increased, spontaneous penile erection

And did I mention that tadalafil is not recommended for the following consumers.

• Patients with a myocardial infarction within the last 90 days
• Patients with unstable angina or angina occurring during sexual intercourse
• Patients with New York Heart Association Class 2 or greater heart failure in the last 6 months
• Patients with uncontrolled arrhythmias, hypotension (greater than 90/50 mm Hg), or uncontrolled hypertension (greater than 170/100 mm Hg)
• Patients with a stroke within the last 6 months

One more thing.
There are rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration). Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

Are ya feelin’ lucky?

Erectile dysfunction is often a symptom of other ongoing diseases. Be smart, see your qualified healthcare provider if you experience impotence.

6/26/07 21:47 JR