Periodically, the Food and Drug Administration (FDA) issues public notifications about products sold over the counter and on the Internet that, despite being promoted as dietary or "natural," contain hidden prescription drugs. The most common contaminated products are those sold for sexual enhancement, weight loss, and body building. Weight loss products recently found to contain drugs or chemicals include GoLean Detox, Ultra Fit, 1 Day Diet, Slim Bio Capsules, and Slimmer Extreme Thermogenic Formula. Sexual enhancement products recently found to include drugs or chemicals include Red Stallion Extra Strong, Natural V=GRA, Yong Gang, Golden Ant, Instinct Best Sexual Enjoyment, Black King Kong, and Nectar Del Amor.
Among the hidden drugs in weight loss products are drugs that were removed from the market by the FDA, prescription and over-the-counter medications approved for uses other than weight loss, and other untested or unstudied ingredients. Go Lean Detox contains the prescription drug sibutramine (Meridia), a weight loss drug removed from the market in 2010 after clinical trials found that it significantly increased heart rate and blood pressure, leading to increased risk of heart attack, stroke, and other cardiac problems. Patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke are at greater risk for these adverse effects. GoLean Detox also contains phenolphthalein, a chemical that potentially increases the risk of cancer. Slimmer Extreme Thermogenic Formula contains sibutramine and phenolphthalein. Ultra Fit and 1 Day Diet contain sibutramine, as well as N-desmethylsibutramine, a substance chemically similar to sibutramine. Slim Bio Capsules contain sibutramine, N-desmethylsibutramine, benproperine (a cough suppressant not approved by the FDA), diphenhydramine (an over-the-counter antihistamine used for seasonal allergies that can cause sedation), and sildenafil and tadalafil-active ingredients in the FDA-approved prescription drugs Viagra and Cialis, used to treat erectile dysfunction. When taken together with a nitrate product (such as nitroglycerin, used to treat angina and other heart-related conditions), sildenafil and tadalafil can cause a significant drop in blood pressure from excessive vasodilation.
Supplements labeled for enhancement of sexual performance also contain prescription drugs to treat erectile dysfunction and non-FDA-approved drugs. Red Stallion Extra Strong has been found to contain tadalafil. Natural V=GRA and Yong Gang contain sildenafil and tadalafil. Golden Ant, Nectar Del Amor, and Instinct Best Sexual Enjoyment each contain sildenafil. As noted above, tadalafil and sildenafil, if taken with a nitrate product, can cause significant hypotension. Black King Kong contains sildenafil and moroxydine (a non-FDA-approved antiviral).
The FDA identified supplements containing these active drugs and chemicals when examining international mail shipments. Many of these tainted products come from outside the United States. However, the FDA is not able to closely supervise and examine all products that claim to be supplements. In fact, the Dietary Supplement Health and Education Act of 1994 does not require the FDA to approve dietary supplements prior to sale. Instead, the manufacturer is expected to confirm that products are safe and that claims made about them are true. If suspicions exist that a product is not safe or not as advertised, the FDA must investigate. The agency then has the authority to remove any unsafe or contaminated products from the market.
Nurses and NPs should assess patients for use of over-the-counter drugs, including substances sold as dietary supplements, when conducting a medication history. Patients may not consider these to be medications and, therefore, not report them unless specifically asked. It's important for patients to understand that not all products sold as dietary supplements are FDA approved. Consumers should use caution when purchasing and using over-the-counter products, especially those claiming to induce weight loss, enhance sexual performance, or promote body building. The FDA's Beware of Fraudulent Dietary Supplements webpage (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm) offers advice on identifying potentially tainted products. Nurses should use this information to teach patients to be active partners in maintaining their health and safety by avoiding products that
* claim to be alternatives to FDA-approved drugs or have similar effects to prescription drugs.
* claim to be legal alternatives to anabolic steroids.
* claim to have rapid effects (for example, sexual enhancement products that work in minutes to hours) or long-lasting effects (products that work for 24 to 72 hours).
* have marketing that is not primarily in English or is conducted via mass e-mails.
* have labels that warn that performance-enhancement drug tests may be positive.
* have claims that sound too good to be true or exaggerated (for example, products that are "quick and effective," "totally safe," and "guaranteed").
* claim extraordinary benefits supported by personal "testimonials" or use words such as "scientific breakthrough."
Nurses and other health care providers should report any adverse effects from these or similar products to the FDA's MedWatch program at http://www.fda.gov/Safety/MedWatch/default.htm. For a full list of FDA public notifications on tainted weight loss products and a short teaching video for consumers, go to http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Med. For a full list of FDA public notifications on tainted sexual enhancement products, see http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/Med. For more information on tainted body building products, see http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm173739.htm.