Undeclared Sulfoaildenafil, an analogue of Sildenafil was found in Drive Total Energy products Rock Hard Extreme and Passion Coffee dietary supplements by the FDA (Food and Drug Administration). Sildenafil is an FDA-approved drug for erectile dysfunction treatment – it is the active ingredient of Viagra.
The FDA says the undeclared Sulfoaildenafil can interact with some prescription medications, such as nitroglycerin, and dangerously bring down an individual’s blood pressure. The active ingredient also interacts with other medications, especially those taken by patients with heart disease, high cholesterol, hypertension (high blood pressure) and diabetes. A high percentage of males with these conditions suffer from erectile dysfunction and may be seeking out these products.
Drive Total Energy has told the FDA it has not received any reports of adverse events linked to the two products. In a communiqué, the company wrote:
“Out of an abundance of caution and concern for the health and welfare of our customers, Drive Total Energy is voluntarily notifying our customers of the FDA’s findings.
Drive Total Energy takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals. We take the utmost pride in our products’ quality control without compromising our customer’s health.”
The two products, Rock Hard Extreme and Passion Coffee are sold on web sites, online marketplaces and retail outlets. They are presented in single packets, blister packs, and 10-count capsule Rock Hard Extreme single pack Lot # 1152010, expiration date Jan. 15, 2013; Rock Hard Extreme Bottle Lot # 1152010, expiration date Jan. 15, 2013; Passion Coffee UPC 7 97882 00001 2.
Purchasers of these products should cease using them immediately, the FDA urges. They should be returned to where they were bought for a full refund.
Customer-queries should be addressed to Tel. 1-619-825-9422 during Pacific Coast Time office hours, Monday to Friday.
Drive Total Energy says it did not knowingly or intentionally break the law when selling these products.
Patients and health care professionals are encouraged to report any side effects or adverse reactions related to these products to the
Erectile Dysfunction, also known as ED or Male Impotence, is a common problem that affects nearly half of all men over 40 years of age at some stage. The problem becomes more common as the man gets older.
ED has many causes. Experts say that approximately 70% of cases have a physical cause, and 30% have a psychological cause. They add that there are frequently both physical and psychological reasons for the condition.
ED can be caused by:
- Some medications
- Neurogenic disorders, such as brain and spinal cord injuries, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, and stroke.
- Cavernosal disorders, such as Peyronie’s disease
- Psychological problems, such as stress, performance anxiety, clinical depression, schizophrenia, substance abuse, generalized anxiety disorders and personality disorders.
- Surgery, such as surgery of the prostate, bladder, colon or rectum.
- Radiation therapy, such as that used for the treatment of prostate cancer.
- Aging
- Kidney failure
- Several vascular and cardiovascular diseases
- Diabetes
- Smoking
- Some studies have linked circumcision to higher risk, while others have not
- Long periods of cycling with the wrong type of saddle
Source: FDA
Written by Christian Nordqvist