Sunday, March 30, 2008

FDA Warns Against "Blue Steel" and "Hero" Supplements for Erectile Dysfunction.

The FDA has issued a warning against the use of "Blue Steel" and "Hero" dietary supplements, currently sold online for erectile dysfunction. The warning stems from the unapproved ingredients that have been found in the pills that may dangerously lower blood pressure and are not disclosed on the product label.

The undisclosed chemicals are similar to the active ingredient in Viagra, and may cause a dangerous interaction with prescription medications. Blue Steel and Hero are being marketed as “all natural”, raising concerns that patients who take prescription nitrates will purchase the supplements unsuspectingly. Most people with erectile dysfunction have diabetes or heart disease, and products marketed as "all naural" are likely to be viewed as safe and effective.

Healthcare professionals or anyone who has used the product and had an adverse event are encouraged to report it to the FDA's MedWatch program by phone at 800-FDA-1088, or go to the FDA's website to file a report.

If you have erectile dysfunctiion, please speak with your doctor to obtain and FDA approved treatment or prescription. The FDA is considering regulatory action to protect consumers from purchasing illegal products via the Internet.

Erectile dysfunction is a common problem and the causes are varied. Most men who experience erection problems are already in poor health. Evaluation of the cause is mandatory to properly target the treatment, something that should not be taken lightly. For an overview of erectile dysfunction, including treatment options, please visit the Cleveland Clinic's Department of Urology and Internal Medicine website.

Source: News release, FDA ◦

Coronary Artery Calcium Score Shown to Predict Heart Disease in Minorities

Doctors can now utilize coronary artery calcium (CAC) scoring to predict the incidence of coronary heart disease in Blacks, Hispanics and Chinese. Dr. Robert Detrano (University of California, Irvine) and colleagues are the first to study the relationship between coronary calcium and the incidence of heart attack in the various ethnic groups. The findings are presented following a 3.8-year analysis of the Multi-Ethnic Study of Atherosclerosis (MESA) study. Dr. Detrano says that because coronary calcification is less prevalent in these ethnic groups, it may be more significant. He stresses that the test is equally predictive in whites and minority groups.

Another name for coronary artery calcium scoring is cardiac CT – a computerized scan that takes pictures of the heart to detect the presence of calcium that is not normally present in the blood vessels. The test is not widely utilized, because the information provided is somewhat vague,especially for those with known heart disease, but for patients who have low to moderate risk for heart attack, it may yield some useful information. Calcium is present in the coronary arteries even in the absence of coronary artery disease that causes obstruction to blood flow to the heart. Cardiac CT, or CAC cannot precisely define the percentage of blockage that is present in the coronary arteries.

The test is also considered expensive. According to Dr. Detrano, “Cost is one of the problems with this test. Of a scan that costs $600, $400 will be marketing costs. So whether or not you agree that this test is useful, it's beyond the means of many individuals and many societies". However, the results will further Dr.Detrano's studies in China.

Experts believe that calcium scoring should be used cautiously, cost aside. The study should not lead practitioners to order calcium scoring tests for everyone. However, Dr. Detrano says "The results prove that coronary-calcium detection is a strong predictor of heart attack and disease for African Americans, Hispanics, and Chinese Americans and whites.

The test is non-invasive and still less costly than a cardiac catheterization, leading many patients to request it from their physician. A combination of coronary artery calcium scoring, complete history and physical exam, cholesterol profile and other heart testing should still be used to absolutely define your risk for coronary artery disease. The MESA study provides clarification for physicians regarding the accuracy of CAC in non-white populations, a variable that was not previously known.

Ref: March 27, 2008, New England Journal of Medicine. ◦