Tag Archives: FDA

Infant Sleep Positioners Dangerous

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Update on Infant Sleep Positioners from the FDA.  Get them out of the cribs NOW!! ~ Nurse Mommy

FDA and the Consumer Product Safety Commission (CPSC) are warning people not to use sleep positioners for their babies, because there is a chance they could suffocate. In the last 13 years, at least 12 babies between the ages of one and four months have died when they suffocated in positioners, or when they became trapped between a sleep positioner and the side of their crib or bassinet.

People have been using positioners to keep their babies in certain positions when they sleep. Some positioners are flat pads with side bolsters. Others are inclined like a wedge, or have some other design. These products may be promoted to reduce acid reflux, minimize “flat head” syndrome, or even to prevent sudden infant death syndrome (SIDS). But there is no scientific evidence to support any of these claims.

Many parents and other people who care for babies know that babies should be placed on their backs to sleep. This reduces the chance of SIDS by nearly half. They may worry about how to make sure their babies stay on their backs. But once babies are able to roll over onto their tummies, it is okay to leave them there, because babies who can flip over can also turn their heads, which reduces their chance of suffocation. However, if babies flip over or scoot around while in a sleep positioner, they can have a hard time freeing their faces from the device or they can become trapped between the positioner and the side of their crib or bassinet.

So do not use infant sleep positioners. They are not necessary, and they can be dangerous. Put your baby to sleep on his or her back, and keep the crib free of pillows, comforters, quilts and toys. That way, your baby has room to safely move or turn while sleeping. Here is an easy way to remember – follow the ABCs of safe sleep – Alone on the Back in a bare Crib.

And if you have any questions, contact your child’s healthcare provider.

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Infant Sleep Positioners Pose Suffocation Risk per FDA

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This was just posted yesterday by the FDA.  Wanted to make sure it made it my readers ASAP!!~Nurse Mommy

Food and Drug Administration (FDA) Notice

Posted: September 29, 2010

Two government agencies are warning parents and other caregivers not to put babies in sleep positioning products as two recent deaths underscore concerns about suffocation.

The Food and Drug Administration (FDA) and the Consumer Product Safety Commission issued the warning after reviewing reports of 12 known infant deaths associated with the products.

The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head. The sleep positioners are intended to keep a baby in a desired position while sleeping. They are often used with infants under 6 months old.

To reduce the risk of Sudden Infant Death Syndrome (SIDS), the American Academy of Pediatrics recommends infants be placed to sleep on their backs on a firm surface free of soft objects, toys, and loose bedding.

Advice for Consumers

STOP using infant positioning products. Using this type of product to hold an infant on his or her side or back is dangerous and unnecessary.

NEVER put pillows, sleep positioners, comforters, or quilts under the baby or in the crib.

ALWAYS place a baby on his or her back at night and during nap time.

REPORT an incident or injury from an infant sleep positioner to the Consumer Product Safety Commission by visiting www.cpsc.gov/cgibin/incident.aspx5 or calling 800-638-2772, or to FDA’s MedWatch program6.

Suffocation and Other Dangers

In the last 13 years, the federal government has received 12 reports of babies known to have died from suffocation associated with their sleep positioners. Most of the babies suffocated after rolling from the side to the stomach.

In addition to the deaths, the commission has received dozens of reports of babies who were placed on their back or side in the positioners only to be found later in hazardous positions within or next to the product.

“We urge parents and caregivers to take our warning seriously and stop using these sleep positioners so children can be assured of a safe sleep,” says Inez Tenenbaum, chairman of the Consumer Product Safety Commission.

FDA pediatric expert Susan Cummins, M.D., M.P.H, says parents and caregivers can create a safe sleep environment for babies if they leave the crib free of pillows, comforters, quilts, toys, and other items.

“The safest crib is a bare crib,” she says. “Always put your baby on his or her back to sleep. An easy way to remember this is to follow the ABC’s of safe sleep—Alone on the Back in a bare Crib.”

Medical Claims

Some manufacturers have advertised that their products prevent SIDS, gastroesophageal reflux disease (GERD)—in which stomach acids back up into the esophagus—or flat head syndrome, a deformation caused by pressure on one part of the skull.

Although in the past FDA has approved a number of these products for GERD or flat head syndrome, new information suggests the positioners pose a risk of suffocation.

As a result, FDA is requiring makers of FDA-cleared sleep positioners to submit data showing the products’ benefits outweigh the risks. FDA is also requesting that these manufacturers stop marketing their devices while FDA reviews the data.

Infant sleep positioner manufacturers who are making medical claims without FDA clearance must stop marketing those products immediately, agency experts say, adding there’s no evidence the devices have benefits that outweigh the risk of suffocation.

“At this time, there is no scientifically sound evidence to support the medical claims being made by the manufacturers of these infant sleep positioners,” says Cummins.

This article appears on FDA’s Consumer Updates page7, which features the latest on all FDA-regulated products.

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Do You Have Beetles in Your Baby Formula?

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ATTENTION formula babies:  Is your mama feeding you Similac?  You might want her to read this new posting from the FDA.  This  one is not pretty! ~ Nurse Mommy

Abbott Voluntarily Recalls Certain Similac® Brand Powder Infant Formulas That Did Not Meet Its Quality Standards

Contact:
Consumer Hotline
(800) 986-8850

FOR IMMEDIATE RELEASE – Sept. 22, 2010 – ABBOTT PARK, Ill. – Abbott is initiating a proactive, voluntary recall of certain Similac-brand, powder infant formulas in the U.S., Puerto Rico, Guam and some countries in the Caribbean.

Abbott is recalling these products following an internal quality review, which detected the remote possibility of the presence of a small common beetle in the product produced in one production area in a single manufacturing facility. The United States Food and Drug Administration (FDA) has determined that while the formula containing these beetles poses no immediate health risk, there is a possibility that infants who consume formula containing the beetles or their larvae, could experience symptoms of gastrointestinal discomfort and refusal to eat as a result of small insect parts irritating the GI tract. If these symptoms persist for more than a few days, a physician should be consulted.

The recall of these powder infant formulas includes:

  • Certain Similac powder product lines offered in plastic containers.
  • Certain Similac powder product lines offered in sizes such as 8-ounce, 12.4-ounce and 12.9-ounce cans.

To immediately find out if the product in your possession is included in this recall, parents and caregivers should visit www.similac.com/recall9, and type in their lot number to determine if their product is affected, or call (800) 986-8850.

No Abbott liquid infant formulas are impacted. Products not involved in the recall include all Abbott Nutrition liquid ready-to-feed and concentrated infant formulas and all powder and liquid specialty formulas, such as Similac Expert Care™ Alimentum®, Elecare®, Similac Expert Care™ Neosure®, Similac® Human Milk Fortifier, and metabolic formulas for inherited disorders.

About the Recall

  • The company is implementing a plan to address this matter in the affected manufacturing facility, which is expected to be completed shortly. No other facilities or products are involved in this recall.
  • Abbott has consulted with the U.S. FDA regarding this recall.

Information for Parents and Caregivers

  • Products with affected lot numbers should be returned to Abbott at no cost to the consumer.
  • Parents and caregivers can go to www.similac.com/recall10 or call Abbott’s consumer hotline, (800) 986-8850, 24 hours a day, seven days a week.
  • Both the website and the consumer hotline have specific details on how to complete the return process.

Holger Liepmann, executive vice president, Abbott Nutrition said:

“Abbott understands that parents expect to feed their children only the highest quality product. We are taking this action so that parents know that the infant formula products they provide unquestionably meet the highest quality standards for which they are known. We regret any inconvenience this situation poses to parents and consumers.”

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