HEALTH

Study finds pre-pregnancy obesity poses increased risk of heart defects in babies

BY Michael Johnsen

ATLANTA The largest study of obesity during pregnancy and babies with heart defects in the United States found that women who were overweight or obese before they became pregnant had an approximately 18% increased risk of having a baby with certain heart defects, compared with women who were of normal body mass index before they became pregnant, the Centers for Disease Control and Prevention announced in a press release issued Thursday.

Severely obese women had approximately a 30% increased risk, according to the CDC study, “Association Between Prepregnancy Body Mass Index and Congenital Heart Defects,” recently published in the American Journal of Obstetrics and Gynecology.

 “Congenital heart defects are the most common types of birth defect, and among all birth defects, they are a leading cause of illness, death, and medical expenditures,” stated Edwin Trevathan, director of the CDC?s National Center on Birth Defects and Developmental Disabilities. “Women who are obese and who are planning a pregnancy could benefit by working with their physicians to achieve a healthy weight before pregnancy.”

The study looked at 25 types of heart defects and found associations with obesity for 10 of them. Five of these 10 types were also associated with being overweight before pregnancy. Women who were overweight but not obese had approximately a 15% increased risk of delivering a baby with certain heart defects.

“These results support previous studies, as well as provide additional evidence, that there is an association between a woman being overweight or obese before pregnancy and certain types of heart defects,” added Suzanne Gilboa, epidemiologist at CDC?s National Center on Birth Defects and Developmental Disabilities, and primary author of the study. “This provides another reason for women to maintain a healthy weight. In addition to the impact on a woman?s own health and the known pregnancy complications associated with maternal obesity, the baby?s health could be at risk.”

One important limitation of the study is that BMI was calculated based on self–reported weight and height, and weight may have been underreported by women during the study interview. Although the study found an association between overweight and obesity and the risk of certain birth defects, further study is needed to determine whether body weight is the direct cause of these birth defects, the agency noted.

The analysis included 6,440 infants with congenital heart defects and 5,673 infants without birth defects whose mothers were interviewed as part of the National Birth Defects Prevention Study. The NBDPS is funded by the CDC to collect information from mothers of children with and without birth defects in Arkansas, California, Georgia, Iowa, Massachusetts, New York, North Carolina, Texas and Utah. This study is the largest effort ever undertaken in the United States to identify risk factors for birth defects.

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The Preval Group showcasing two new products

BY Michael Johnsen

PORTLAND, Maine The Preval Group is currently showcasing two new products for the retail channel — Wrecking Balm Tattoo Fade System and Quietus, a homeopathic remedy for symptoms of tinnitus.

With the tattoo fading system Wrecking Balm, available as a direct-to-consumer brand since 2006 and more recently through specialty channels (tattoo parlors), there is the potential for a new category in the drug channel. The product contains DemoMatic, approved as a Class I device by the Food and Drug Administration, and a Suffusion gel that helps exfoliate the upper layers of the skin, among other ingredients.

Current retail packaging contains between a one to two month supply of the product, but takes on average between six and eight months to fully fade the tattoo, which means return business.

Approximately 40 million Americans already have tattoos, the Preval Group, and citing the American Society of Dermatological Surgery, half of them consider removing permanent body art like tattoos at some point in their lives.

Quietus offers symptomatic relief to the symptoms of tinnitus, a ringing in the ears associated with exposure to loud noise that about 1-in-6 Americans experience in their lifetime. At greater risk to tinnitus are carpentry and construction workers, airport workers, gun enthusiasts and hunters, machine operators and night club workers and musicians.

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NAD: Bayer Healthcare ad claims for Aleve are supported

BY Michael Johnsen

NEW YORK The National Advertising Division of the Council of Better Business Bureaus on Thursday determined that Bayer Healthcare can substantiate claims made in packaging, television, print and Internet advertising for Aleve and Aleve Liquid Gels products.

Claims at issue included:

  • “minimum daily dosing” and “minimum label dosing”;
  • “all day pain-free movement” and “stop pain all day”; and
  • “Only two Aleve can stop pain all day” and “that would take twice as many Advil.”

NAD, the advertising industry’s self-regulatory forum, reviewed the claims at issue, following a challenge by Wyeth Consumer Healthcare, manufacturer of Advil, a competing analgesic.

Wyeth also challenged a pill-count comparison graph that two Aleve caplets stacked next to four Advil caplets, with the claim “Just 2 Aleve = 4 Advil.”

 NAD noted in its decision that Bayer has, since at least 2002, made a pill-count comparison in its advertising, including the recent claim that two Aleve capsules equal four Advil capsules. The advertiser maintained, and NAD accepted, that the pill count comparison is based on the respective FDA-approved labels for Aleve and Advil.

Consistent with past decisions, NAD accepted product labels, approved by the Food and Drug Administration as reasonable support for the durational capacity of Aleve and Advil.

NAD determined that the advertiser provided a reasonable basis for its “pain-free” claim, based on its FDA-approved label. Further, NAD determined that it was unlikely that consumers who use over-the-counter analgesics would expect to experience a complete absence of any pain.  The NAD also found that the advertiser established a reasonable basis for its value calculator, based on a minimum daily dose of two Aleve pills versus four Advil tablets.

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