FDA Warns Against Unapproved Erectile Dysfunction Products

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Unapproved erectile dysfunction drugs are touted as a “healthy man alternative to the little blue pill.”
Unapproved erectile dysfunction drugs are touted as a “healthy man alternative to the little blue pill.”

The FDA has issued a warning that unapproved erectile dysfunction (ED) drugs containing 100 mg sildenafil, the active ingredient in Viagra, are being advertised over broadcast and internet radio without a prescription.

The sildenafil dosage is particularly dangerous for the elderly and those with impaired liver or kidney function. When sildenafil interacts with nitrates, blood pressure can plummet.

The drugs are touted as a “healthy man alternative to the little blue pill,” “healthy man,” or “the power pill,” according to the FDA. Acme Generics in India is the manufacturer, but the label also bears the name Sun Pharma. The seller may also be distributing unapproved tadalafil.

Although no adverse events have been reported, health care professionals are urged to report any adverse events to FDA's MedWatch (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home).

Reference

FDA warns consumers not to use unapproved erectile dysfunction products advertised on the radio. [news release] FDA; March 16, 2018.

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