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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Upsher-Smith launches site devoted to dry skin management

BY Michael Johnsen

MINNEAPOLIS Upsher-Smith Laboratories earlier this month launched a Web site devoted to the management of the dry skin associated with Keratosis Pilaris as part of a branding effort around the AmLactin family of moisturizers.

“The goal of littleredbumps.com is to educate people through an innovative creative approach about managing the dry skin associated with KP,” stated Mark Evenstad, president of Upsher-Smith. “The Web site features Laurie Rose also known as Miss Little Red Bumps, and is designed to entertain people who are searching for information about KP.”

As the virtual host of www.littleredbumps.com, Rose speaks to visitors with enticing information about KP in three vignettes.

“KP is not fun because it often raises its ugly head in a person’s teens and twenties so this contemporary site will be informative and entertaining because of its upbeat messages and free music and video downloads,” stated Alan Fleischer, professor and chair of the department of dermatology at Wake Forest University School of Medicine. “I see lots of patients who are suffering from extremely dry skin associated with KP so the management tips I provide on the site will also be of practical value.”

The site also offers visitors coupons for the AmLactin family of moisturizers, including AmLactin, AmLactin XL and AmLactin Foot Cream Therapy.

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