Smoking Early in Pregnancy Raises Risk of Heart Defects in Infants

Maternal cigarette smoking in the first trimester was associated with a 20 to 70 percent greater likelihood that a baby would be born with certain types of congenital heart defects, according to a study by the Centers for Disease Control and Prevention. Congenital heart defects are the most common type of birth defects, contributing to approximately 30 percent of infant deaths from birth defects annually.

The study found an association between tobacco exposure and certain types of defects such as those that obstruct the flow of blood from the right side of the heart into the lungs (right ventricular outflow tract obstructions) and openings between the upper chambers of the heart (atrial septal defects). The study is in the Feb. 28 issue of the journal Pediatrics.

"Women who smoke and are thinking about becoming pregnant need to quit smoking and, if they're already pregnant, they need to stop," said CDC Director Thomas R. Frieden, M.D., M.P.H. "Quitting is the single most important thing a woman can do to improve her health as well as the health of her baby."

Based on the findings of this and other studies, eliminating smoking before or very early in pregnancy could prevent as many as 100 cases of right ventricular outflow tract obstructions and 700 cases of atrial septal defects each year in the United States. For atrial septal defects alone, that could potentially save $16 million in hospital costs.

"Successfully stopping smoking during pregnancy also lowers the chances of pregnancy complications such as preterm delivery and that an infant will have other complications such as low birth weight," said Adolfo Correa, M.D., Ph.D., medical officer in CDC′s National Center on Birth Defects and Developmental Disabilities.

The findings from the study, "Maternal Smoking and Congenital Heart Defects in the Baltimore-Washington Infant Study," are based on a large population-based case-control study of congenital heart defects conducted in the United States; 2,525 case and 3,435 control infants born from 1981 to 1989 were included in this analysis.

Congenital heart defects are conditions present at birth that decrease the ability of the heart to work well, which can result in an increased likelihood of death or long-term disabilities. They affect nearly 40,000 infants in the United States every year.

It is estimated that right ventricular outflow tract obstructions affect approximately 2,500 infants per year and atrial septal defects affect approximately 5,600 infants per year in the United States. In 2004, U.S. hospital costs for all congenital heart defects were estimated at approximately $1.4 billion.

Source:  PRNewswire

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FDA Cautions on Accurate Vitamin D Supplementation for Infants

The Food and Drug Administration today alerted parents and caregivers that some liquid Vitamin D supplement products are sold with droppers that could allow excessive dosing of Vitamin D to infants.

The FDA also advised manufacturers of liquid Vitamin D supplements that droppers accompanying these products should be clearly and accurately marked for 400 international units (IU). In addition, for products intended for infants, FDA recommends that the dropper hold no more than 400 IU.

The American Academy of Pediatrics (AAP) has recommended a dose of 400 IU of Vitamin D supplement per day to breast-fed and partially breast-fed infants. The easiest way to ensure that an infant will not get more than the recommended dose is to use a product supplied with a dropper that will give no more than 400 IU per dose. The AAP’s recommendations are provided hereExit Disclaimer.

Excessive amounts of Vitamin D can be harmful to infants, and may be characterized by nausea and vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, and fatigue, as well as more serious consequences such as kidney damage.

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Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops

Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

71683791111-1
Lot SMF007
Exp 09/10
Infants' Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz.

71683791111-1
Lot SMF008
Exp 09/10
Infants' Mylicon® Gas Relief Dye Free Non-Staining Drops 1 oz.

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday – Friday, 8:00 a.m. – 8:00 p.m. EST) or via the internet at www.mylicon.com for instructions regarding how to dispose of the product and request a replacement or refund.

Infants' MYLICON® drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants' MYLICON® GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm
Regular Mail: Use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178

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CPSC and Carter's Advise Parents of Rashes Associated with Heat Transferred, or "Tag-less," Labels

The U.S. Consumer Product Safety Commission (CPSC) and Carter's, Inc., of Atlanta, Georgia, are advising parents and caregivers that they have received reports that a small percentage of babies and infants have developed rashes on the upper back after wearing Carter's clothing with heat-transferred, or "tag-less," labels.

This advisory applies to Carter's Fall 2007 product line. The Fall 2007 line utilizes a label on the inside back of the garment that has a raised surface with a solid, rather than a stenciled, background. This advisory does not apply to previous and current product lines, which utilize labels with stenciled backgrounds.

The garments, which were made in various countries, were sold at Carter's own retail stores and at department and national chain stores.

If your child develops a rash on the upper back after wearing garments that have a "tag-less" label with a solid background, you should stop using these garments. If the rash persists or worsens, you should contact your pediatrician. For additional information, visit Carter's website at http://www.carters.com/corporate/tagless_message.aspx, contact Carter's toll free at 1-888-282-4674 or by email at contactus@carters.com

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