HEALTH

‘Life…supplemented’ study examines women’s wellness habits

BY Michael Johnsen

WASHINGTON — More than 25% of American women are focused on and proactive about their health and well-being, according to a national study released last week by “Life…supplemented.”

The study — My Wellness Scorecard National Study — ranked women on a scale from “AlphaWell” (those who are extremely proactive and meticulous about their health) to “OhWell” (those who do little to nothing about maintaining their health). Only 1% of women who participated in the study wree “AlphaWells”; 26% were “Wells”; and 42% and 31% were “WannabeWells” and “OhWells,” respectively.

“The average woman wears so many ‘hats’ that she often neglects taking adequate time for herself,” stated Cheryl Forberg, registered dietitian for “The Biggest Loser,” and consultant to the “Life…supplemented” campaign. “There’s no greater reminder than Women’s Health Month that women need to invest in themselves. If they spend just a little time evaluating their overall well-being, it is easy to develop healthy habits that can last a lifetime.”

According to the My Wellness Scorecard National Study, 58% of women reported doing a fairly good job of avoiding processed foods, watching what they eat when it comes to cholesterol-rich dishes and avoiding such fatty foods as whole milk and fatty meat. However, nearly 35% admitted they eat more cholesterol-rich and fatty foods than they should.

When it comes to vitamins and other dietary supplements, 61% of women reported taking a multivitamin, but only 46% took a multivitamin daily.

During the month of May, the “Life…supplemented” campaign, a consumer wellness program, is encouraging women to embrace the three pillars of health: healthy diet + supplements + exercise, to help them get back on the right track to good health.

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FDA to debate pediatric APAP dosing during mid-week advisory committee meeting

BY Michael Johnsen

WASHINGTON — The Food and Drug Administration is convening its Nonprescription Drugs Advisory Committee Tuesday and Wednesday to debate mandating weight-based dosing for pediatric medicines containing acetaminophen on the Drug Facts label, as well as the potential expansion of dosing instructions to incorporate children under the age of 2 years old, according to material posted online by the FDA on Friday.

“[The Consumer Healthcare Products Association] supports inclusion of dosing information for children less than 2 years of age on labels of [over-the-counter] single-ingredient acetaminophen products intended for children, and the amendment of the OTC Internal Analgesics Monograph to reflect this labeling,” the association stated as part of a “Briefing Book” submitted for the meeting. “Further, our members also support dosing based on weight as the preferred method for dosing children.”

The Consumer Healthcare Products Association earlier this month announced that the industry would voluntarily homogenize liquid APAP concentrations for children in an effort to reduce medication errors. Beginning mid-2011 and continuing through early 2012, CHPA members will discontinue manufacturing concentrated infant drops and convert these products to the same concentration used today for children’s (ages 2 to 11 years) acetaminophen products (160mg/5mL), the CHPA noted in its pre-meeting minutes. The industry initiative is consistent with guidance from three advisory committees to FDA in 2009 that voted 36-1 in favor of standardizing acetaminophen liquid products to one concentration. In addition, the new products will be packaged with flow restrictors to make it difficult to ingest large amounts of liquid in the event of an accidental unsupervised ingestion. Dosing devices for infants will be calibrated oral syringes and for older children, calibrated dosing cups will be used.

That 2009 advisory committee meeting found that errors involving acetaminophen use in children are commonly caused by parents’ confusion about how much to dose, though CHPA cited research finding only 5% of all APAP-related overdosing in children were due to parent error; the vast majority of overdosing cases resulted from accidental ingestion.

APAP is the most commonly used children’s medicine for relieving pain and reducing fever, according to the CHPA. Estimates suggested that in any given week, approximately 12% of children up to age 11 years have taken acetaminophen. The peak of acetaminophen use is among children ages 6 months to 23 months of age, according to the association’s meeting materials.

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FDA warns consumers of counterfeit ExtenZe

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers about a counterfeit product represented as "ExtenZe," which is the name of an authentic dietary supplement for male sexual enhancement.

The counterfeit product looks similar to the actual product, but either contains tadalafil, or a combination of tadalafil and sildenafil, all active ingredients in FDA-approved prescription medicines for erectile dysfunction.

"This incident is an example of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals," said Ilisa Bernstein, deputy director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "These types of products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being ‘all natural.’ Consumers should exercise caution before purchasing products promoted for these uses."

The counterfeit product has the following lot numbers on the packages: LOT 1110075 and LOT F050899.

“Consumers who have an ExtenZe product should check the lot numbers on the package to make sure they do not have a counterfeit product,” the FDA said. “Consumers who think they might have the counterfeit product should stop taking the product and contact their healthcare professional if they are experiencing any negative side effects.”

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