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FDA Warning on Hidden Ingredients in Supplements

May 4, 2025

Public Notification: Hidden Drug Ingredient in Big Penis Male Sexual Stimulant

Overview

  • The FDA advises against using Big Penis Male Sexual Stimulant.
  • The product is marketed for sexual enhancement.
  • Discovered via international mail inspections.

Key Findings

  • Contains sildenafil, the active ingredient in Viagra.
  • Sildenafil is for erectile dysfunction treatment.
  • Interaction Warning:
    • Can interact with nitrates in prescriptions like nitroglycerin.
    • Risk: dangerously low blood pressure.
    • At-risk groups: individuals with diabetes, high blood pressure, cholesterol, or heart disease.

Reporting Instructions

  • Adverse events or side effects should be reported to FDA’s MedWatch:
    • Online submission via MedWatch
    • Download form and fax to 1-800-FDA-0178.

Additional Information

  • There is a trend of dietary supplements with hidden drugs/chemicals.
  • Often advertised as "all-natural" for sexual enhancement, weight loss, bodybuilding.
  • FDA cannot test all dietary supplements for harmful ingredients.

Recommendations

  • Exercise caution with products claiming to be dietary supplements.

Resources

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