Consumer alert: FDA recalls Long Weekend
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