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Your Toddler

Recall: 1.6 million Unstable Mainstays Chest of Drawers

2:00

Ameriwood Home is recalling about 1.6 million Mainstays chests of drawers sold in the U.S. and Canada because they can easily tip-over if not anchored to the wall, posing serious tip-over and entrapment hazards that can result in death or injuries to children. The chests do not comply with the performance requirements of the U.S. voluntary industry standard.

This recall involves Mainstays four-drawer chests of drawers with plastic drawer glides and a single decorative pull on each drawer. The composite wood chests were sold in six colors: alder, black forest, white, weathered oak, walnut and ruby red. The chests measure 40- 5/16 inches high by 27-11/16 inches wide by 14-11/16 inches deep.

Model numbers included in the recall are 5412012WP, 5412301WP, 5412328WP, 5412015WY, 5412301WY, 5412012PCOM, 5412015PCOM, 5412026PCOM, 5412213PCOM, 5412214PCOM, 5412301PCOM, 5412317PCOM, and 5412328PCOM.

The model number is printed on the instruction manual. 

CPSC has received one report of an injury after a chest of drawers tipped over onto a four-year-old.

The chests of drawers were sold at Walmart stores and other retailers nationwide and online at Walmart.com from April 2009 through May 2016 for about $60.

Consumers should immediately stop using any recalled chest that is not properly anchored to the wall and place it into an area that children cannot access. Contact Ameriwood for a free repair kit that includes a wall anchoring device and feet for the unit. Consumers who require additional installation guidance should contact Ameriwood for further assistance.

Consumers can contact Ameriwood toll-free at 888-222-7460 from 8 a.m. to 5 p.m. CT Monday through Friday, or online at www.Ameriwood.com and click on Support for more information. 

More images of the recalled chests of drawers can be found online at: https://www.cpsc.gov/Recalls/2017/Ameriwood-Home-Recalls-Chests-of-Drawers#

 

Your Toddler

Uncut Grapes Can Choke Young Children

1:30

While good nutrition involves plenty of fresh fruits and vegetables, there’s one fruit that should not be given to children 5 and under; grapes.

Uncut grapes are dangerous for young children because their size and smooth texture can cause choking and even death.

There have already been three choking cases in Scotland, out of which two turned out to be fatal, involving boys who were 5 or younger.

A report published in the journal Archives of Disease in Childhood notes that food is responsible for more than half of the choking incidents, which end in deaths when it comes to children under the age of 5.

"There is general awareness of the need to supervise young children when they are eating ... but knowledge of the dangers posed by grapes and other similar foods is not widespread," noted Dr. Jamie Cooper, co-author of the report, from the emergency department at Royal Aberdeen Children's Hospital.

According to the same report, there is no awareness concerning the specific risks that soft fruits raise, and the relatively small numbers of cases per hospital, which occur every year, don't fully reflect the extent to which this issue can affect young children.

Kids that have choked on grapes don’t often make the news, but according to research conducted in the United States and Canada, grapes occupy third place when it comes to deaths caused by food-related incidents, after hotdogs and sweets.

There are two reasons why grapes are so dangerous, especially in very young children: first, because the airways of the children are small and their swallow reflex is not fully developed, and second due to the smooth texture of the fruit.

Other foods with similar texture can pose a choking hazard, such as tomatoes.  Health experts suggest that grapes and tomatoes be cut in half twice. Anytime a child (or an adult for that matter) is eating uncut grapes or small tomatoes they should pay attention to their eating and not mechanically pop them into their mouths – like when watching TV or playing video games.

Grapes and tomatoes are good sources of fiber and healthy nutrients, just make sure that your little one has his or hers’ cut up so they are not easily choked when eating them.

Story source: Livia Rusu, http://www.techtimes.com/articles/189851/20161224/grapes-as-a-choking-hazard-doctors-say-lack-of-awareness-puts-young-children-at-risk.htm

 

 

Your Toddler

Bathroom Safety Tips

1:45

While most of us may not think of a bathroom as a dangerous place, it often is where home injuries occur. From infants to the elderly, bathrooms are notorious for being places one can slip and fall, drown, be scalded and even electrocuted.

Young children are particularly vulnerable to accidents in the bathroom. The simplest way to avoid bathroom injuries is to make sure that an adult is always with an infant, toddler or young child when he or she is in the room. This may mean installing a latch on the door at adult height so the child can't get into the bathroom when you aren't around. Also, be sure any lock on the door can be unlocked from the outside, just in case your child locks him or herself in.

Here are 5 tips to help prevent bathroom injuries to young children:

1      Supervision: Children can drown in only a few inches of water, so never leave a young child alone in the bath, even for a moment. If you can't ignore the doorbell or the phone, wrap your child in a towel and take him along when you go to answer them. Bath seats and rings are meant to be bathing aids and will not prevent drowning if the child is left unattended. Never leave water in the bathtub when it is not in use. It's also important to have anything and everything you think you'll need within arm's reach before getting down to business. So that you don’t have to step away from your child, have items such as soap and shampoo, washcloths, a towel or two, moisturizer for infants, diapering supplies and a change of clothes within reach.

2      Slips and falls: Install no-slip strips on the bottom of the bathtub. Put a cushioned cover over the water faucet so your child won't be hurt if he bumps his head against it. Get in the habit of closing the lid of the toilet, and get a toilet lid lock. A curious toddler who tries to play in the water can lose his balance and fall in. Potty-training is a time when parents should be in the bathroom to make sure curious toddlers don’t decide to play with the toilet water.

3      Water temperature: To prevent scalding, adjust your water heater so the hottest temperature at the faucet is no more than 120 degrees Fahrenheit (48.9 degrees Celsius). Test the water with your wrist or elbow to check that it feels warm, not hot. When your child is old enough to turn the faucets, teach him to start the cold water before the hot.

4      Medicine and toiletry storage: Keep all medicines in containers with safety caps. Remember, however, that these caps are child-resistant, not childproof, so store all medicines and cosmetics high and out of reach in a locked cabinet. Don't keep toothpaste, soaps, shampoos, and other frequently used items in the same cabinet. Instead, store them in a hard-to-reach cabinet equipped with a safety latch or locks.

5      Electric appliances: If you use electrical appliances in the bathroom, particularly hair dryers and razors, be sure to unplug them and store them in a cabinet with a safety lock when they aren't in use. It is better to use them in another room where there is no water. An electrician can install special bathroom wall sockets (ground-fault circuit interrupters) that can lessen the likelihood of electrical injury when an appliance falls into the sink or bathwater.

Every year, young children are injured or die in bathrooms. Many families never think to lock a bathroom door when no one is in it, but making sure there is a lock in place and is used may prevent an unnecessary tragedy. 

Story source: https://www.healthychildren.org/English/ages-stages/baby/bathing-skin-care/Pages/Preparing-Your-Bathing-Area.aspx

 

Your Toddler

12 Tips to Make a Home Safer for the Grandkids

2:00

Grandparents and grandkids are two-way blessings. Grandchildren benefit from having a close relationship with their grandparents. They have an extra pair of eyes to watch over them and a lot of hugging and spoiling.

Grandparents get the joy of being around their grandchildren, watching them grow and develop and yes- spoiling them.

Many younger families depend on grandparents to supplement with childcare. Some grandparents are the preferred choice for day care. And of course, sometimes it’s just a family visit.

Not all grandparents think about making their home safer for the grandkids because they aren’t always around them. They may not be aware of what to look for or what to do to make their home safer for little ones. It may have been a long time since a grandparent has had to think about having a child in the house. A lot more information is quickly available regarding child safety than in years past.

The American Association for Retired Persons (AARP) recently published an article with tips for making a home safe for grandchildren. Reading it reminded me of when my child was little and the visits our family used to have with my husband’s parents and mine. I never thought about having a list of suggestions to help them safeguard their home for our child. Most of the time there wasn’t a problem, but occasionally there were big safety issues that they just hadn’t thought about.

If you’ve been thinking about how to talk with yours or your spouse’s parents about making their home more kid-proof – here’s some excellent tips from “ Grandparent Central”, AARP:

1. Keep meds out of reach. About 38 percent of child-poisoning cases involve grandparents' medications, so clear all drugs from countertops, tables and drawers. Put a childproof lock on the medicine cabinet. Make sure your purse is not within reach of your grandchild.

2. Get rid of crib-clutter. Not long ago, cribs were filled with such things as stuffed toys, little pillows, bumper pads and blankets. Nowadays, more people are aware that these items can present a suffocation hazard and are best left out of the crib

3. Baby should sleep on back. Make sure that baby is sleeping on his or her back and not face down or on their side in the crib.

4. Lock up detergent pods. These colorful packets of liquid laundry or dishwasher soap look like candy. They can pose "a serious poisoning risk to young children," says a study in the journal Pediatrics. If you use these products, make sure they are locked in a cabinet and cannot be accessed by curious little hands.

5. Make furniture tip-proof. Flat-screen TVs and modern furniture are particularly prone to tipping if little ones try to pull themselves up. Attach anti-tip brackets or straps to safely secure these items. And don't forget outlet covers, drawer locks, stairway gates, and edge and corner guards for furniture.

6. Walkers and wheelchairs. These items may look like toys to a young child. Make sure they are either out of sight or that someone keeps an eye on the child if they seem a little too intrigued by them.

7. Keep guns under lock and key. One of the most important tips! If you're among the 1 in 3 Americans with a gun, always keep it unloaded in a locked cabinet, with the ammunition stored separately.

8. Be present when your grandchild is with your pet. According to the Centers for Disease Control and Prevention (CDC), more than 77,000 children under age 10 are treated each year in emergency rooms for dog bites.

9. Guard pools and drains.  Always keep your cell phone with you when your grandchild is in the pool in case you need to call 911. If you've got a backyard pool or hot tub, you likely know to prevent access with a childproof gate. But you may not be aware of the danger of drains: Suction forces can be powerful enough to trap small children underwater.

10. Watch all water. Since toddlers' heads are heavy in proportion to bodies, they can easily be pulled down. That's why even an inch of standing water is dangerous. Put a childproof lock on the toilet and drain bathwater immediately.

11. Stove safety. When kids are around, use back burners and always keep handles of pots and pans turned in.

12. Beware of choking hazards. 5 of the most overlooked choking hazards for young children are mini-batteries, jewelry, refrigerator magnets, pen caps and loose change. Five items you may not typically think about.

These 12 tips are obviously good for every family household but may be particularly helpful when someone is not used to having children at their house for extended periods of time.

Grandparents and grandchildren often share a special bond that can grow even more secure and stronger when the home safe during their visit.

Story source: Bulletin staff, http://www.aarp.org/home-family/your-home/info-2016/home-safety-tips-grandkids.html

Your Toddler

AAP: Winter Car Seat Safety

2:00

So far in Texas, this year’s El Nino weather pattern has made for a pretty mild winter compared to previous years. But, other areas around the country are being hit hard with a wintery punch and it’s only a matter of time till temperatures drop and snow and ice find their way to the Lone Star State.

Winter can be a bit tricky for child car seat use. While it sounds like the opposite might be true, bulky clothing such as coats and snowsuits should not be worn under the car seat harness.

More padding - more cushion right? That seems logical until you know what happens when a car crashes. In a wreck, fluffy padding immediately flattens out from the force, leaving extra space under the harness. A child can then slip through the straps and be thrown from the seat.

So how can you keep your little one warm and protected while buckled up? The American Academy of Pediatrics (AAP) has these tips to help strike a comfortable and safer balance.

·      Use a coat or blanket over the straps. You can add a blanket over the top of the harness straps or put your child's winter coat on backwards (over the buckled harness straps) after he or she is buckled up. Some parents prefer products such as poncho-style coats or jackets that zip down the sides so the back can flip forward over the harness. Keep in mind that the top layer should be removable so your baby doesn't get too hot after the car warms up.

·      Use a car seat cover ONLY if it does not have a layer under the baby. Nothing should ever go underneath your child's body or between her body and the harness straps. Be sure to leave baby's face uncovered to avoid trapped air and re-breathing. Many retailers carry car seat bundling products that are not safe to use in a car seat. Just because it's on the shelf at the store does not mean it is safe!

·      Dress your child in thin layers. Start with close-fitting layers on the bottom, like tights, leggings, and long-sleeved bodysuits. Then add pants and a warmer top, like a sweater or thermal-knit shirt. Your child can wear a thin fleece jacket over the top. In very cold weather, long underwear is also a warm and safe layering option. As a general rule of thumb, infants should wear one more layer than adults. If you have a hat and a coat on, your infant will probably need a hat, coat, and blanket.

·      Don't forget hats, mittens, and socks or booties. These help keep kids warm without interfering with car seat straps. If your child is a thumb sucker, consider half-gloves with open fingers or keep an extra pair or two of mittens handy — once they get wet they'll make your child colder rather than warmer.

·      Get an early start. If you're planning to head out the door with your baby in tow on winter mornings, you need an early start. You have a lot to assemble, and your baby may not be the most cooperative. Plus, driving in wintry conditions will require you to slow down and be extra cautious.

·      Tighten the straps of the car seat harness. Even if your child looks snuggly bundled up in the car seat, multiple layers may make it difficult to tighten the harness enough. If you can pinch the straps of the car seat harness, then it needs to be tightened to fit snugly against your child's chest.

·      Remember, if the item did not come with the car seat, it has not been crash tested and may interfere with the protection provided in a crash. Never use sleeping bag inserts or other stroller accessories in the car seat.

·      Store the carrier portion of infant seats inside the house when not in use. Keeping the seat at room temperature will reduce the loss of the child's body heat in the car.

·      Pack an emergency bag for your car. Keep extra blankets, dry clothing, hats and gloves, and non-perishable snacks in your car in case of an on-road emergency or your child gets wet on a winter outing.

·      Make sure your cell phone is charged. If there is an emergency, you want to be able to reach 911 or call for assistance in case of a flat tire or engine trouble.

This is a time when there is a lot of holiday travel from state to state or just down the road to grandma’s house.

Remember, it’s not just children in car seats whose coats shouldn’t be tucked under the harness, adults and older children should make sure their coats are on the outside of the seat-belt.

Little steps can make a big difference in everyone’s safety.

Source: https://healthychildren.org/English/safety-prevention/on-the-go/Pages/Winter-Car-Seat-Safety-Tips.aspx

Your Toddler

Detergent Pods Causing Severe Eye-Damage to Kids

1:45

Warnings have been out for a while on the dangers of small children getting their hands on laundry detergent pods that often look like packets of candy. The main threat has been poisoning, but another problem has surfaced; vision threatening burns, according to a new study.

Researchers analyzed data from the U.S. Consumer Product Safety Commission and looked at eye injuries caused by chemical burns or conjunctivitis among 3 to 4 year olds between 2010 and 2015.

They found that more than 1,200 preschoolers in the United States suffered eye burns from these single-use detergent pods. In 2012, only 12 such burns were reported. By 2015, that number was almost 500.

"These pods look like toys, they look like candy, and kids are finding them, playing with them, puncturing them, and the chemicals inside the pods are getting into their eyes," said lead researcher Dr. R. Sterling Haring, from the Johns Hopkins University Bloomberg School of Public Health in Baltimore.

The injuries often occur when children are playing with the pods and they break, squirting liquid into their eyes. Eye burns can also happen when the soap gets on children’s hands and they touch their eyes, Haring said.

"Laundry detergent pods are playing a large and growing role in chemical eye burns among small children," he said.

As a proportion of all chemical burns to the eye among kids, burns from these liquid laundry pods rose from less than 1 percent in 2012 to 26 percent in 2015, Haring said.

"I am expecting the number of burns in 2016 to be higher than 2015. These numbers have grown every year," he said.

The American Cleaning Institute (ACI), an industry trade group, has voluntarily introduced improved safety standards for many of these products. New guidelines call for pods that can withstand squeezing pressure from a child. The pods also have a bitter substance on their outer layer to keep children from swallowing their contents. And packaging of the pods is now opaque so the laundry pods can't be seen from outside the packaging, the group said. Many detergent manufacturers have already begun making some of these changes.

One reason the detergent pods can be so dangerous is because the chemicals used are alkaline instead of acidic. Alkaline chemicals are more likely to cause lasting damage than acidic chemicals, Haring said.

The effects of alkaline chemicals can be devastating to a young child’s vision.

"The detergent can burn the cornea, leaving a scar that can impair vision or potentially cause blindness," Haring said. "In the most severe cases, children may need a corneal transplant to restore vision."

If a child has a chemical burn, step one is to rinse the eye with cool water under a faucet for 20 minutes, Haring said.

"Call 911 or take the child to an emergency room, but do it after you rinse the eye for 20 minutes," he said. "That is the first step, and that's the most important step. The longer those chemicals sit on the eye, the higher the likelihood they are going to leave a lasting burn and threaten vision.”

Detergent pods have become very popular because they are convenient, but parents and caretakers sometimes forget that they are packed with dangerous chemicals. These pods need to be kept in an area where small children cannot see them or reach them.

The report was published online in the journal JAMA Ophthalmology.

Story source: Steven Reinberg, http://www.webmd.com/parenting/news/20170202/laundry-detergent-pods-linked-to-eye-burn-danger-in-kids#1

 

Your Toddler

Target Recalls Water-Absorbing Easter Toys

1:15

You may want to check the toy eggs your child received around the Easter holiday to make sure he or she does not have one of the more than 560,000 water-absorbing Easter egg and dinosaur toys being recalled.

Target is voluntarily recalling Hatch & Grow Easter Eggs, Easter Grow Toys and Hatch Your Own Dino Egg product due to the possibility of a “serious ingestion hazard, “ according to the U.S. Consumer Product Safety Commission (CPSC).

If swallowed, the toy can expand inside a child's body and cause "intestinal obstructions, resulting in severe discomfort, vomiting, dehydration, and could be life threatening," according to the announcement. Surgery is required to remove the toy. Medical professionals and parents should be aware that there is a possibility that the toys might not show up on an x-ray.

Consumers should contact Target at 800- 440-0680 between 7 a.m. to 8 p.m. CT Monday through Sunday, online at www.target.com and click on “Recalls” at the bottom of the page, then on “School/Stationery/Seasonal” for more information, or the “Product Recalls” tab on Target’s Facebook page.

This recall involves Hatch & Grow Easter Eggs, Easter Grow Toys and Hatch Your Own Dino. Hatch & Grow Easter Eggs and Easter Grow Toys have model number 234-25-1200 on the back of the product’s packaging. Hatch Your Own Dino Egg has model number 234-09-0016 on the label inserted in the product’s packaging. The pink, blue, or purple Hatch & Grow Easter Eggs include a white bunny, brown bunny, or butterfly.  The Easter Grow Toys include a yellow chick, brown bunny, or white bunny. The Hatch Your Own Dino Eggs are purple or yellow/green and contains one of eleven dinosaurs.

The products were sold at Target stores February 2017 through March 2017, for about $1.00.

Currently, there have not been any incidents reported.

Story source: https://www.cpsc.gov/Recalls/2017/Target-Recalls-Water-Absorbing-Toys

Your Toddler

Ikea Recalls 29 Million Chests and Dressers After More Children Die

2:00

The U.S. Consumer Product Safety Commission (CPSC), in cooperation with IKEA North America, of Conshohocken, Pa., is announcing the recall of all chests and dressers that do not comply with the performance requirements of the U.S. voluntary industry standard (ASTM F2057-14).  The recalled children’s chests and dressers are taller than 23.5 inches and adult chests and dressers are taller than 29.5 inches.  The 29 million units of recalled chests and dressers include: MALM 3-drawer, 4-drawer, 5-drawer and three 6-drawer models and other children’s and adult chests and dressers.  The recalled chests and dressers are unstable if they are not properly anchored to the wall, posing a serious tip-over and entrapment hazard that can result in death or serious injuries to children.

 On July 22, 2015, CPSC and IKEA announced a repair program for the chests and dressers that included a free wall-anchoring repair kit for the MALM chests and dressers and other IKEA chests and dressers. Two tragic fatalities involving MALM chests and dressers occurred prior to the announcement of the repair program:

·      In February 2014, a 2-year-old boy from West Chester, Pa. died after a 6-drawer MALM chest tipped over and fatally pinned him against his bed.

·      In June 2014, a 23-month-old boy from Snohomish, Wash. died after he became trapped beneath a 3-drawer MALM chest that tipped over. 

Subsequent to the July 2015 announcement, CPSC and IKEA learned of additional tip-over incidents, including a February 2016 incident in which a 22-month-old boy from Apple Valley, Minn. died when a MALM 6-drawer chest fell on top of him. 

 None of the chests or dressers in the above-listed incidents had been anchored to the wall.  In addition to the three deaths, IKEA received reports of 41 tip-over incidents involving the MALM chests and dressers, resulting in 17 injuries to children between the ages of 19 months and 10 years old.

 The MALM chests and dressers are constructed of particleboard or fiberboard and are white, birch (veneer), medium brown, black-brown, white stained oak (veneer), oak (veneer), pink, turquoise, grey, grey-turquoise, lilac, green, brown stained ash (veneer), and black.  A 5-digit supplier number, 4-digit date stamp, IKEA logo, country of origin and “MALM” are printed on the underside of the top panel or inside the side panel. 

 Since 1996, IKEA chests and dressers have been labeled to identify IKEA, the model name and the manufacturing date.

 The recalled MALM chests were sold from 2002 through June 2016 for between $70 and $200. 

 Recalled MALM Chest and Drawers:

·      MALM 3 – Sold 10/2002 to 6/2016

·      MALM 4 – Sold 6/2002 to 6/2016

·      MALM 5 -  Sold 10/2002 to 4/2006

·      MALM 6-  Sold 6/2002 to 6/2016

·      MALM 6 LONG – Sold 11/2002 to 6/2016

·      MALM 6 – Sold 4/2006 to 6/2016

IKEA also received 41 reports of tip-overs involving chests and dressers other than MALMs, resulting in the deaths of three children and 19 injuries to children:

·      In July 1989, a 20-month-old girl from Mt. Vernon, Va. died after  an unanchored GUTE 4-drawer chest tipped over and pinned her against the footboard of a youth bed.

·      In March 2002, a 2½-year-old boy from Cranford, N.J. died after an unanchored RAKKE 5-drawer chest tipped over and fatally pinned him to the floor.

·      In October 2007, a 3-year-old girl from Chula Vista, Calif. died after a KURS 3-drawer chest tipped over and fatally pinned her to the floor.  It is unknown as to whether the dresser was anchored or not.

Other recalled Chest and Drawers:

Most of the non-MALM chests and dressers included in this recall are listed on the IKEA website at www.IKEA-USA.com/recallchestsanddressers.

 Since 1996, IKEA chests and dressers have been labeled to identify IKEA, the model name and the manufacturing date.

 CPSC and IKEA are urging consumers to inspect their recalled IKEA chests and dressers to ensure that they are properly anchored to the wall.  Chests and dressers should be properly anchored to the wall whether or not they meet the ASTM standard.  Consumers should move any unanchored chests and dressers into storage or other areas where they cannot be accessed by children until the chests and dressers are properly anchored to the wall or removed from the home.

To receive a refund or free wall-anchoring kit for IKEA chests and dressers listed above, visit an IKEA retail store, go to www.IKEA-USA.com/recallchestsanddressers , or call 866-856-4532 anytime.

A child dies every two weeks and a child is injured every 24 minutes in the U.S. from furniture or TVs tipping over, according to CPSC data.

Remedy

Consumers should immediately stop using any recalled chest and dresser that is not properly anchored to the wall and place it into an area that children cannot access.  Contact IKEA for a choice between two options: refund or a free wall-anchoring repair kit.

Consumers are entitled to a full refund for chests and dressers manufactured between January 2002 and June 2016. Consumers with chests and dressers manufactured prior to January 2002 will be eligible for a partial store credit. 

Consumers can order a free wall-anchoring repair kit. Consumers can install the kit themselves or IKEA will provide a one-time, free in-home installation service, upon request. Consumers can reorder the kits throughout the life of their chest and dresser.

Story Source: http://www.cpsc.gov/en/Recalls/2016/IKEA-Recalls-29-Million-MALM-and-Other-Models-of-Chests-and-Dressers/

 

 

Your Toddler

FDA Targets Unapproved Eardrops

1:30

For years, physicians may have been unknowingly prescribing unapproved eardrops used to treat ear pain and swelling, to parents for their children’s ear aches. The drugs have not been evaluated for safety, quality and effectiveness says the U.S. Food and Drug Administration (FDA).

The agency notified the drugs' makers to stop marketing the drops following a few reports of local allergic reactions of the ear, eye, face, neck and mouth. The drops can also cause itching, stinging, burning and irritation of the ear, according to an FDA news release.

"If we don't know whether these drugs have any benefits, we should not accept any possible risk of side effects," said the FDA's Dr. Charles Lee in the news release.

The FDA did not release the names of the companies or the medications involved, but did note, "unapproved prescription otic [ear] drug products containing the following ingredients are covered by this action:

·      Benzocaine;

·      Benzocaine and Antipyrine;

·      Benzocaine, Antipyrine, and Zinc acetate;

·      Benzocaine, Chloroxylenol and Hydrocortisone;

·      Chloroxylenol and Pramoxine;

·      Chloroxylenol, Pramoxine, and Hydrocortisone.

“Taking enforcement actions against these unapproved products will protect patients from unnecessary risks,” said Cynthia Schnedar, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “There are many FDA-approved prescription products to treat ear infections, so we expect little or no impact on patients from the removal of these unapproved and potentially unsafe products.”

The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status.  The FDA’s action does not affect FDA-approved prescription otic products, or legally marketed otic products sold over-the-counter.

Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be contaminated or manufactured incorrectly, which could result in patients receiving the wrong dose, even when administered according to the labeled directions for use, the agency said.

The FDA recommends that you check with your doctor if you think your child may have been prescribed one of these products or has exhibited side effects. You can ask for an alternative medication that has been FDA approved.

Sources: Margaret Farley Steele, http://consumer.healthday.com/general-health-information-16/doctor-news-206/unapproved-ear-drops-targeted-by-fda-700970.html

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453348.htm

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