HEALTH

Report predicts potential OTC status for more than a dozen Rx drugs

BY Michael Johnsen

NEW YORK There are 14 prescription drugs that exceeded $20 billion in sales in 2006 that may have the potential to reach the over-the-counter market in four years, according to a report from Kalorama Information, released Thursday.

The markets for Rx-to-OTC switch products are forecast to reach $5 billion in 2008 and increase by close to 40 percent by 2010. More than half of the revenues in 2008 will be from allergy medications that have already made the switch, such as Claritin, Benadryl, Sudafed, Nasalcrom, Mucinex and most recently Zyrtec. However, the forecast compound annual growth rate from statin switches between 2008 and 2013 far outpaces that of the allergy category (127.5 percent versus 3 percent).

“Lagging FDA approvals led to a brief absence of Rx-to-OTC switches in the pharmaceutical marketplace, but 2006 and 2007 saw a number of switches,” noted Melissa Elder, the report’s author. “We believe this product management tactic will continue to be aggressively utilized as companies seek ways to extend revenue lifecycles.”

Factors affecting this recent upswing in Rx–to-OTC switches include patent expirations, generic competition, suitability for OTC shelves, drug safety and efficacy, petitions to the FDA and manufacturer trends. Some future potential switches include leading gastrointestinal drugs Prevacid, Protonix and AcipHex; antilipidemic agents Mevacor, Pravachol, Lescol and Zocor; the allergy treatment Allegra; the migraine therapy Imitrex, and a number of oral contraceptives.

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Zipfizz anounces Pacific Northwest distribution

BY Michael Johnsen

MILL CREEK, Wash. Zipfizz Corp., the makers of Zipfizz, an energy drink mix, announced Wednesday that the Odom Corp, will begin distributing its product line in Alaska, Washington and Oregon.

“We are very excited to be working with Odom,” stated Riley Livingston, president and chief executive officer of Zipfizz. “This will significantly enhance our presence in Alaska and the Pacific Northwest where Zipfizz is already extremely popular.”

Livingston said Odom will distribute the company’s flagship product, the Zipfizz Health Energy Drink Mix, as well as the Zipfizz Liquid Shot and Zipfizz Multi-Vitamin and Immune Support.

The Zipfizz Healthy Energy Drink Mix is packaged in a test tube-like, single-serving container, and contains only 10 calories, no sugar and two net carbs. When mixed with 16 to 20 ounces of water, it offers 25 nutritional ingredients, including nine vitamins, eight minerals, electrolytes and antioxidants.

Zipfizz Liquid Shot is a 4 oz. serving that delivers an energy boost. It contains a balance of B-12 and electrolytes and contains no sugar.

Zipfizz Multi-Vitamin and Immune Support is a daily immune boost, multi-vitamin with electrolytes which comes in a powder form and is packaged in a slim, single-serving pack. It contains only 10 calories, no sugar, and two carbohydrates. The effervescent formula, when mixed with 16 to 20 ounces of water, offers 28 nutrients and vitamins.

Zipfizz products are available at Costco, QFC, Sam’s Clubs, Target, Rite Aid, Walgreens, Safeway, H-E-B and Bartell Drugs, the company stated.

The Odom Corporation distributes a wide range of beverages, including Coca-Cola, Miller Beer and Coors Beer. The company sells more than 600,000 cases of varied alcoholic and non-alcoholic products each month and processes an average of 500 orders a day.

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FDA warns about excess selenium in Total Body products

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration on Wednesday announced that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products “Total Body Formula” and “Total Body Mega Formula.”

The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.

On March 27, the FDA warned consumers not to purchase or use “Total Body Formula” in flavors Tropical Orange and Peach Nectar and “Total Body Mega Formula” in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails and fatigue. 

Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin. 

Presently, FDA has 43 reports of adverse reactions including cases from Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee and Texas. 

Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium—up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (200 micrograms) indicated on the labels of the products. 

The FDA continues to investigate the matter to determine how excessive amounts of selenium were added to the products. 

Total Body Essential Nutrition, the distributor of the “Total Body Formula” and “Total Body Mega Formula” products, has voluntarily recalled the affected products. According to the company, the products were distributed nationwide. 

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