HEALTH

Diagnostic Devices in contract with two states for Medicaid-covered blood glucose monitoring systems

BY Michael Johnsen

CHARLOTTE, N.C. Diagnostic Devices on Wednesday announced contracts with the states of Illinois and Missouri around Medicaid coverage of its Prodigy line of blood glucose monitoring systems and test strips.

“We will continue working with other states for coverage under their Medicaid programs, and to demonstrate to them the savings Illinois and Missouri taxpayers will realize with the Prodigy family of products,” stated Rick Admani Abulhaj, Diagnostic COO.

A recent study by University of Florida PharmD candidates found the “talking” feature of the Prodigy AutoCode meter made a “significant improvement” in overall diabetes control and compliance among patients who took part, the company noted.

The Prodigy Voice meter for blind or low-vision diabetes patients has been honored with awards from both the National Federation of the Blind and the American Foundation for the Blind, the company added.

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FDA warns consumers about body-building products that contain steroids, related substances

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Tuesday issued a Public Health Advisory warning consumers to stop using body-building products that are represented as containing steroids or steroid-like substances and oftentimes misbranded as dietary supplements.

The agency also issued a Warning Letter to American Cellular Laboratories for marketing and distributing body-building products containing synthetic steroid substances. Although these products are marketed as dietary supplements, they are not dietary supplements, but instead are unapproved and misbranded drugs.

The PHA notifies consumers and health care professionals that the FDA has received reports of serious adverse events associated with the use of body-building products that claim to contain steroids or steroid-like substances. Those adverse events include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (artery blockage in the lung). The PHA also advises consumers to stop taking body building products from any manufacturer that claim to contain steroid-like substances or to enhance or diminish androgen-, estrogen-, or progestin-like effects in the body.

The FDA has received five adverse event reports, including serious liver injury, in men taking products marketed as dietary supplements by American Cellular Laboratories, including TREN-Xtreme and MASS Xtreme. Acute liver injury is generally known to be a possible side effect of using products that contain anabolic steroids. Some of the cases resulted in hospitalization, but there were no reports of death or acute liver failure.

“Products marketed for body-building and claiming to contain steroids or steroid-like substances are illegal and potentially quite dangerous,” stated FDA commissioner Margaret Hamburg. “The FDA is taking enforcement action today to protect the public.”

The products listed in the Warning Letter to American Cellular Laboratories,  include “TREN-Xtreme,” “MASS Xtreme,” “ESTRO Xtreme,” “AH-89-Xtreme,” “HMG Xtreme,” “MMA-3 Xtreme,” “VNS-9 Xtreme,” and “TT-40-Xtreme,” and are sold on the Internet and in some stores. These products, which claim to contain steroid-like ingredients but in fact contain synthetic steroid substances, are unapproved new drugs because they are not generally recognized as safe and effective.  In addition, the products are misbranded because the label is misleading and does not provide adequate directions for use.

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Fairhaven Health presents clinical study results for FertilAid for Men

BY Michael Johnsen

BELLINGHAM, Wash. Fairhaven Health, which manufactures a male fertility supplement, recently presented a clinical study at the American Society of Andrology’s annual meeting, the company announced Tuesday.

Results from a recent clinical study indicate that FertilAid for Men provides significant improvements in sperm quality for men with abnormal sperm parameters. In particular, results of the 90-day, double blind, placebo-controlled study suggest that FertilAid for Men supports significant increases in the total number of normal motile sperm. Previous clinical studies have suggested a strong relationship between the “total normal-motile sperm count” and the fertility of the man.

“Most of the men that had increased sperm counts while taking FertilAid for Men also showed improvements of 20% or more in the number of healthy sperm,” stated lead researcher J. Ellington.

FertilAid for Men is a male fertility supplement that integrates vitamins, antioxidants, a proprietary blend of herbal ingredients and the amino acid, l-carnitine. Scientific literature suggests that antioxidants can improve male fertility by reducing oxidative stress and damage to spermatozoa, while supporting fundamental protective functions of the seminal plasma which insulate and nourish sperm. In independent studies, antioxidants reduce “free-radical” damage, in particular to the sperm’s DNA or genetic material, resulting in better pregnancy outcomes.

Research on the amino acid, l-carnitine, yields similar pro-fertility findings: L-carnitine supports “sperm metabolism”, or the ability for sperm to break down complex molecules to produce energy. L-carnitine has been shown in a number of clinical studies to enhance several fundamental sperm parameters, including sperm concentration, motility and normal morphology.

Fairhaven Health’s distribution partners include drugstore.com, BabyCenter and CVS.com, as well as a number of clinics and private practices nationwide.

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