FDA Health Advisory for Certain Dietary Supplements

Many people take dietary supplements to support their diets with herbs, vitamins and minerals. In some instances, dietary supplements can provide health benefits. In others, the unexpected risks can injure or even kill consumers.

The distribution and marketing of dietary supplements is regulated by the Food and Drug Administration (FDA), which protects consumers by enforcing strict guidelines for food and drug safety and by warning the public not to purchase or consume potentially dangerous products. In order to avoid increased health risks, consumers should independently research the products they use and heed the advice of the FDA.

Dietary Supplements Containing Tadalafil

Recently, the FDA issued a Public Health Advisory, warning consumers against taking certain dietary supplements that were determined to contain a potentially harmful prescription drug ingredient called tadalafil.

Tadalafil is an active ingredient in a prescription drug approved in Europe to treat male erectile dysfunction. An interaction between tadalafil and certain drugs containing nitrates may cause a drastic and potentially life-threatening lowering of blood pressure. The FDA has determined that the following dietary supplements contain tadalafil:

• SIGRA
• STAMINA Rx
• STAMINA Rx for Women
• Y-Y
• Spontane ES
• Uroprin

Other public health warnings have been issued at the state level for herbal dietary supplements that have tested positive for dangerous prescription drugs. For example, the California State Department of Health Services issued a warning in February 2002 about two Chinese herbal medicine products: (1) PC SPES, which tested positive for the prescription drug warfarin, and (2) SPES, which tested positive for the prescription drug alprazolam.