FDA MedWatch - Prolatis': Recall - Undeclared Drug Ingredient Sulfoaildenafil

Oct 29, 2011 09:19




Prolatis’: Recall - Undeclared Drug Ingredient

AUDIENCE: Consumers

ISSUE: Lab analysis has found Prolatis’ to contain Sulfoaildenafil, an analogue of online pharmacy, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an unapproved drug. The active drug ingredient is not listed on the product label. The analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

BACKGROUND: Product manufactured prior to August 9, 2010 is included in this recall. Prolatis’ is sold nationwide in double blister packs and 40 count bottles.

RECOMMENDATION: Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the compant Press Release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm222327.htm

You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).





GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · 10903 New Hampshire Ave MD 20993 · 800-439-1420
Previous post Next post
Up