Terra Sigillata

Just cleaning out the day job e-mail account early this morning and came across something, I should’ve posted this a month ago when FDA sent me this release.

There are obvious problems with US federal regulation of dietary supplements related to lack of proven efficacy, bioavailability of purported active constitutents, and thinly-veiled medical marketing.

However, few people are aware of the fact that adulteration of dietary supplements is a real problem and, in the case below, potentially life-threatening:


From the FDA MedWatch adverse drug reaction (ADR) reporting program:

MedWatch – The FDA Safety Information and Adverse Event Reporting Program

The FDA notified healthcare professionals and consumers of a warning not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON, illegal drugs with undeclared ingredients that are
promoted and sold on web sites as “dietary supplements” for treating erectile dysfunction and enhancing sexual performance. These products have not been approved by FDA, and there is no guarantee of their safety
and effectiveness, or of the purity of their ingredients.
[emphasis added] They pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.

Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises consumers who have used any of these products to discontinue use and to consult their healthcare provider.

Read the complete MedWatch 2006 Safety summary, including a link to the
FDA News Release, at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#enhance

Comments

  1. #1 Joe
    August 17, 2006

    This problem has been found in “herbal” and homeopathic formulations, as well. I put herbal in quotes because the law makes it easier to push herbs as “supplements” today; but those that are simply labeled herbal are still suspect.

  2. #2 Erectile dysfunction
    May 6, 2009

    Most people think it only happens with older people until it happens to you. Almost 15% of men have sometime in their life has some sort of erectile dysfunction, while men in their sixties this can go up to 75%

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