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Your Toddler

Noisy Homes May Influence Toddler’s Vocabulary

1:00

Have you ever had a hard time understanding someone speak in a noisy restaurant? Imagine if you were trying to learn a new language. That’s just what toddlers are trying to do, learn a language. According to a new study, toddlers learn new words quicker when their environment has less background noise.

"Modern homes are filled with noisy distractions such as TV, radio and people talking that could affect how children learn words at early ages," said study leader Brianna McMillan.

"Our study suggests that adults should be aware of the amount of background speech in the environment when they're interacting with young children," said McMillan, a doctoral student in psychology at the University of Wisconsin at Madison.

Researchers from the university assessed the ability of 106 children, aged 22 to 30 months, to learn new words. They found they were more successful when their surroundings were quiet than when there was background noise.

However, researchers noted that providing the children with additional language cues helped them overcome the detrimental effects of a noisy location.

"Hearing new words in fluent speech without a lot of background noise before trying to learn what objects the new words corresponded to, may help very young children master new vocabulary," said study co-author Jenny Saffran, a professor of psychology.

Sometimes, you simply can’t avoid a noisy environment- especially if there are other children around. Saffron says there is a way to overcome that.

“… When the environment is noisy, drawing young children's attention to the sounds of the new word may help them compensate," she added.

Story source: Robert Preidt, https://consumer.healthday.com/kids-health-information-23/child-development-news-124/noisy-homes-slow-toddler-s-vocabulary-713013.html

 

 

Your Toddler

Thumb Sucking and Nail Biting Linked to Fewer Allergies

1:30

An interesting new study out of New Zealand suggests that young children who suck their thumbs or bite their nails may be at a lower risk for developing allergies.

The study included data from 1000 children born in New Zealand in 1972 or 1973, and spanned three decades.

While the results of the study suggests these habits may lower children’s risks of developing allergies, researchers noted that they are not recommending that kids take up these habits, only that the habits may play a role protecting them against allergies into adulthood.

 "Many parents discourage these habits, and we do not have enough evidence to [advise they] change this," said Dr. Robert Hancox, an associate professor of respiratory epidemiology at the University of Otago in New Zealand. "We certainly don't recommend encouraging nail-biting or thumb-sucking, but perhaps if a child has one of these habits and [it] is difficult [for them] to stop, there is some consolation in the knowledge that it might reduce their risk of allergies.”

The researchers asked the parents of the children participating in the study about their kids’ thumb-sucking habits and nail-biting habits four times: when the kids were 5, 7, 9 and 11 years old. Researchers also tested the children for allergies using a skin-prick test when they were 13, and then followed up with the kids again when they were 32.

It turned out that 38 percent of the children who had sucked their thumbs or bit their nails had at least one allergy, whereas among kids who did not have these habits, 49 percent had at least one allergy.

Moreover, the link between these childhood habits and a lower risk of allergies was still present among the study participants when they were 32 years old. The link persisted even when the researchers took into account potentially confounding factors that may also affect a person's risk of allergies, such as whether their parents had allergies, whether they owned pets, whether they were breast-fed as infants and whether their parents smoked.

By the time the children were 13 years old, researchers found that the ones who both sucked their thumbs and bit their nails were even less likely to have allergies compared with children who had just one of the two habits. However, by the time they were 32, this association was no longer found.

The study was published in the July edition of the journal Pediatrics.

The results of this study are inline with another study published in 2013, which found that children whose mothers sucked their kids’ pacifiers clean had a lower risk of developing allergies.

"Although the mechanism and age of exposure [to pathogens] are different, both studies suggest that the immune response and risk of allergies may be influenced by exposure to oral bacteria or other microbes," the researchers wrote in the new study.

The new findings also lend support the so-called hygiene hypothesis, which holds that environments that have too little dirt and germs may make children more susceptible to certain conditions, including allergies. It seems that "exposure to microbial organisms influences our immune system and makes us less likely to develop allergies," Hancox told Live Science.

Kids that suck their thumbs or bite their nails, receive mixed reactions from adults. Most adults will encourage kids to stop biting their nails, while it’s probably 50/50 on the thumb sucking. Either way, it appears that oral bacteria may play a role in lowering the risks of developing allergies in kids.

Story source: Agata Blaszczak-Boxe, http://www.livescience.com/55340-children-thumb-sucking-nail-biting-allergy-risk.html

 

Your Toddler

Babies, Toddlers and Discipline

2.00 to read

In a previous article we looked at the results of a study on whether spanking your child creates more disobedience instead of controlling bad behavior.  According to the research in this particular study, spanking is not an effective form of discipline; in fact, it’s not discipline at all. It only creates more problems down the road.

So, what are some better alternatives to getting your child to behave? 

The first step is to understand what discipline is and how it works. Discipline is not punishment.

Punishment, defined by the Merriam-Webster dictionary is: suffering, pain or loss that serves as retribution or a severe, rough or disastrous treatment.

That’s not the goal of loving parents who are trying to stop a child’s unacceptable behavior.

Discipline, on the other hand, is about teaching. It helps a child learn what is expected and to gradually learn how to control their behavior.  Children learn best when they feel safe and secure and their “good behavior” is encouraged.  The key is to have a good relationship with your child as well as clear and realistic expectations.

There is no one discipline tool that fits all, but there are some guidelines for different age groups. As children mature, techniques need to change to fit your child’s mental and physical growth.

Ages 0-1 years of age (Infants):

Infants should never be disciplined. They are not capable of understanding the meaning of words or able to remember what you’ve asked of them. You’d think that this would be obvious, and to most parents or caregivers it is. But there are some people who don’t get it and not only try to discipline their baby, but get angry when the infant doesn’t do what they want.  Babies are not little adults who have an agenda. They are merely babies and depend entirely on their parents or caregivers for survival.

Loving touches and gentle words are just as important as food and clothing to these little ones.  They need to learn that their world is a safe and nurturing place and that they can trust those around them.  A baby never does anything to deliberately annoy someone. They simply aren’t capable of that kind of manipulation.

Ages 1-3 (Toddlers)

These are the ages when children first sample the world around them through mobility and touch. They are curious, excited and easily frustrated. They learn through touching and moving and oftentimes creating a mess. They get frustrated because they don’t have the skills to accomplish everything they want.  The word “no” can become a part of their limited vocabulary.

Discipline at this age is about setting a few simple boundaries and helping them learn new skills with patience and praise.

Avoid battles, particularly with eating and toilet training. It’s not a war between you and your toddler. Making a mess is normal. This age group demands a lot of attention and patience. Re-directing and praise works better than a constant stream of you saying “no, no, no.” The word no loses its power when repeated constantly.

Toddler-proof your home: The best way to help a toddler stay out of a dangerous situation, or not grab something you don’t want them to have, is to toddler-proof your home. Cover electrical outlets with plastic snap-ons. Move breakable objects to a higher place in the house. Make sure coffee tables don’t have sharp corners.  Secure your TV to the wall and make sure that bookcases are secured. Anything they climb on or pull over needs to be anchored. Make sure that drawers and cabinets cannot be accessed. Put in place kid-safe products designed to block access to these areas.

Toddlerhood is a challenging time, no doubt about it.  They have little self-control and are not rational thinkers. They want to be independent and discover things for themselves but don’t have the communication skills and forethought needed to do so safely so it’s up to you, the parent, to help keep them safe.

Routines, order and consistency: Routines, order and consistency are very important to helping this age feel that the world around them is a safe place. This means regular nap times, meal times and bed times as well as free time to play and explore.  

Since they are just beginning to experience a little independence, toddlers need to know what you expect of them. Terms have to be simple; consequences quick. If your child bites or hits or grabs the cat by the tail, you respond quickly with the appropriate words. “ Do not bite”, “Do not hit,”  “ Do not pull the kitty’s tail”.  Say it every time it happens, and redirect your child to an activity that you can praise. Be consistent in the idea that there are certain actions that are not acceptable and others that are not only acceptable, but also more interesting.

Avoid stressful situations. You’ve spent enough time with your child to know that there are situations that often trigger bad behavior. The most common ones are hunger, sleepiness, and quick changes of venue. Avoid these potential meltdown scenarios with a little advance planning. An example would be that you wouldn’t take your toddler to the grocery store when you know they haven’t had a nap or are hungry. You can pretty well predict how that is going to go.

If you’re taking your child out, keep excursions short unless it’s to the park or playground. Even those trips should have a time limit that you know works well.

Restaurants can be tricky with a toddler. There is a lot of stimulation and not a lot of room for exploring. Find “family friendly” locations and try not to go during the busiest times. If a meltdown occurs, take your child outside, explain the situation in a calm voice and redirect their attention again until he or she calms down. 

Validate their emotions: Let your child know you understand their frustration. Validate their emotions. “I know you don’t like the car-seat, but we have to use it when you ride in the car.” It’s not coddling, it’s validating their feelings but also setting boundaries. When we ride in the car- you’ll be in the car seat. I understand you don’t like it.

You can also bring something your child likes to hold – a stuffed animal, blanket or toy. You can offer a healthy snack or give them a choice between the two, so they feel like they have a measure of control in their life. It’s a learning experience every day for parents as well as toddlers.

Time-outs? A lot has been made of “time-outs.” Time-outs are helpful when used as a discipline tool, but typically they don’t work well for toddlers. They are too young to really understand what it is you’re asking of them and it can be too confusing.  Distraction and redirecting tend to work better for this age.

Praise good behavior: You can correct bad behavior, but don’t forget to praise good behavior.  When a little one only hears what they are doing wrong, they don’t get a sense of the difference between acceptable and unacceptable behavior.  Sometimes re-phrasing in a more positive tone helps. “The puppy likes to be petted, not have her tail pulled. Let’s pet the puppy like this. Look- see the puppy likes that – you’re such a good puppy petter!”

Stay calm: Toddlers can push your buttons.  It’s important to stay calm and to know when you’re getting too upset to parent well.  Losing control can quickly escalate into yelling, hitting and doing or saying something you regret. If your child is home and having a tantrum or repeating the same behavior over and over, give yourself some time to cool down.

When they are in a safe environment like the home, ignoring the tantrum may work best. Sometimes, you just have to let them exhaust themselves while screaming, lying on the floor and flailing about. It’s part of learning that they won’t always get what they want.

Once they settle down, hug them and let them know that you love them and then find something better to do. 

Toddlers will test your patience, your sanity and your self-control. They’ll also make you find creative ways to teach them. Each child is different and requires an approach tailored to their personality and maturity.

And yes, sometimes you reach a point where the battle is more damaging than giving in. Be flexible and give in, but redirect the behavior towards something that you want them to learn or do.

“Alright, mommy is going to give you this piece of candy, and then you’re going to help me put away your building blocks. That’s the way we’re going to make this moment work for both of us. Sound good?”

Toddlers and babies are precious little beings that can make your heart burst with joy and love. Yes, they can be demanding, but they are so worth the extra effort.

In later posts we’ll look at discipline techniques for older children.

Sources: Stephanie Watson, http://www.webmd.com/parenting/guide/7-secrets-of-toddler-discipline

http://www.cyh.com/HealthTopics/HealthTopicDetails.aspx?p=114&np=122&id=2429

Your Toddler

Toddlers Lack of Sleep Tied to Behavior Problems

2:00

Sleep is vital to survival and while we may appear to be doing nothing, our brains are very active. Sleep deprivation can make us grumpy and unable to make good decisions or concentrate. Not only do adults need sufficient amounts of sleep- so do children.

 A new study looks at the affects not enough sleep can have on toddlers and found that those little ones that slept less than 10 hours a night or woke up frequently were more inclined to have emotional and behavioral problems at age five.

Researchers were surprised that the “risks were so strong and consistent” said lead author Borge Sivertsen of Uni Research Health and the Norwegian Institute of Public Health in Bergen.

“While only an experimental study can determine causality, our study does suggest that there is an increased risk of developing such problems, also after accounting for a range of other possible factors,” Sivertsen told Reuters Health by email.

The results were from a long-term study of 32,662 pairs of mothers and children in Norway. The mothers filled out questionnaires when they were 17 weeks pregnant, when the child was 18 months old and again when the child was five years old.

Mothers rated 99 child behaviors on a scale from “not true” to “very true” and reported how long the child slept in a 24-hour period and how often he or she woke up during the night.

At 18 months, almost 60 percent of toddlers were sleeping for 13 to 14 hours per night and about two percent were sleeping for less than ten hours per night. About 3 percent of toddlers woke three or more times per night. Most kids woke a few times per week or less.

Toddlers who slept less than 13 hours per night often had emotional or behavioral problems at the same age, the authors write in JAMA Pediatrics.

They also had a higher risk of internalizing problems such as being emotionally mercurial, anxious and depressed.

While the study doesn’t prove causation, it does lend a lot of credibility to there being a link between too little sleep in toddlers and later emotional and social problems.

“Although it is difficult to tease out causality from observational studies, this longitudinal study does suggest that inadequate sleep in early childhood increases the risks for later emotional and behavioral problems,” said Michelle M. Garrison of Seattle Children’s Research Institute in Washington, who wrote an editorial about the research.

Not all of these children will necessarily develop mental health problems later in life. Other factors also play important roles like the child’s temperament and his or her parent’s emotional health.

If your child seems to have difficulty sleeping well or getting to sleep, talk with your pediatrician about tips to help your little one get the rest he or she needs. 

Source: Kathryn Doyle, http://www.reuters.com/article/2015/04/13/us-toddlers-sleep-behavior-idUSKBN0N41U920150413

 

Your Toddler

Kid’s “Hypoallergenic” Products May Cause Allergic Reactions

2:00

When a child has eczema, doctors often recommend that parents purchase hypoallergenic ointments, creams or lotions to ease the suffering from dry, inflamed skin.

However, according to a new study, many products labeled as hypoallergenic contain ingredients that can cause allergic reactions.

The Federal Drug Administration (FDA) does not regulate the “hypoallergenic” label, said Carsten Hamann, a medical student at the Loma Linda University School of Medicine in California and the lead researcher on the study.

“Kids who have eczema or atopic dermatitis use more lotions and creams and ointments, etc. Ostensibly, their caregivers who purchase these products to use on the kids' skin, give preference to products using these meaningless marketing terms,” Hamann told Reuters Health in an email.

Hamann and his colleagues tested products that might be used by kids with eczema, which affects 17.8 million people in the U.S., according to the National Eczema Association. Patients have patches of red, itchy skin, often on the arms, legs, cheeks, and behind the ears.

Doctors often advise people with eczema to apply moisturizer to the affected areas.  People with eczema tend to have a higher risk of so-called “contact allergies.” That is, they may have allergic reactions to substances that come in contact with their skin, including fragrances, preservatives, and other kinds of chemicals.

Researchers tested 187 cosmetic products found in 6 different stores in California, to see if they contained any of the 80 most common known allergens.  All of the products were specifically marketed as being safe for use by children and labeled as “hypoallergenic”, “ dermatologist recommended/ tested”, “fragrance-free,” or “Paraben free.” Most people assume that these types of products are actually designed to help people who have sensitive skin.

But, researchers found that 89 percent of the products contained at least one allergen, 63 percent contained two or more, and 11 percent contained five or more. The average number of allergens per product was 2.4, the researchers reported in the Journal of Allergy and Clinical Immunology.

Preservatives and fragrances accounted for 58 percent and 29 percent of the allergens, respectively. These ingredients often irritate a skin condition.

Ten percent of the products contained methylisothizolinone, a preservative that is about to be banned in the European Union because it can cause severe skin irritation, according to the researchers.

“It would be very difficult for even the most caring, intelligent and well-read parent to know the names of 80-plus allergens and their synonyms, let alone compare that list of allergens to a 15-plus long ingredient list on the back of a pediatric product,” Hamann said.

Dr. Michael Arden-Jones, a skin disease specialist at the University of Southampton in the U.K., said that defining something as an allergen can be complicated.

“Almost any chemical compound could be implicated as an allergen, so it is almost impossible for a cream to be truly non-allergic,” he told Reuters Health. “Thus, as there is no true ‘hypoallergenic’ cream, there is no agreed meaning of ‘hypoallergenic.’”

Skin experts say that ointments are generally the safest products for kids who have eczema. Creams and lotions contain water and therefore must contain preservatives, making them more likely to contain allergens. Prescription moisturizers are typically reliable. Products with artificial coloring or fragrances or do not have the ingredients listed on the box should be avoided.

The National Eczema Association reviews products and offers the “NEA Seal of Acceptance” for those that do not include known irritants. Depending on the product, the NEA Seal of Acceptance™ Review Panel considers testing data on sensitivity, safety, and toxicity, as well as the ingredients, content, and formulation data. There is a tab on the website dedicated to information on child eczema in infants to older children. Their website is: http://nationaleczema.org.

Sources: Madeline Kennedy, http://www.reuters.com/article/2014/11/21/us-eczema-products-safety-idUSKCN0J529L20141121

http://nationaleczema.org.

Your Toddler

Anchor It!

1:45

The U.S. Consumer Product Safety Commission (CPSC) has launched “Anchor It”, a national public education campaign, to help make people aware of the dangers that free-standing furniture and TVs present, particularly to children.

The annual number of children injured or killed from furniture and TV tip-overs is astounding.

According to CPSC data, unstable and unsecured TVs and large pieces of furniture kill a child every two weeks, on average, in tip-over incidents that are easily preventable.  CPSC also reported that 38,000 Americans go to emergency rooms each year with injuries related to tip-overs of top-heavy furniture or televisions placed on furniture, instead of a TV stand.  Two-thirds of those injuries involved children younger than 5.  Additionally, between 2000 and 2013, 84 percent of the 430 deaths reported to CPSC involved children younger than 10.

A January 2015 CPSC report found that a television tipping over from an average size dresser falls with thousands of pounds of force. 

The impact of a falling TV is like being caught between two NFL linemen colliding at full-speed—10 times. 

“Every 24 minutes in the U.S. a child goes to the emergency room because of a tip-over incident involving furniture or a TV,” said CPSC Commissioners Marietta Robinson and Joseph Mohorovic. “We must take action now. CPSC’s new ‘Anchor It!’ campaign is a call to action for parents and caregivers to ‘get on top of it, before they do.’ If we can prevent one more death, it will be worth it.”

Cards and posters are being distributed parents and caregivers of toddlers at daycare centers and preschools. A list of safety steps parents and caregivers can take are printed on the handouts. They are:

·      Buy and install low-cost anchoring devices to prevent TVs, dressers, bookcases or other furniture from tipping.

·      Avoid leaving items, such as remote controls and toys, in places where kids might be tempted to climb up to reach for them.

·      Store heavier items on lower shelves or in lower drawers.

·      Place TVs on a sturdy, low base and push them as far back as possible, particularly if anchoring is not possible.

·      If purchasing a new TV, consider recycling older ones not currently used. If moving the older TV to another room, be sure it is anchored properly to the wall.

The “Anchor It” campaign’s website (www.Anchorit.gov) shows you how to anchor furniture and television sets properly, with easy to follow instructions. Keep your little one safe and Anchor It!

 

Your Toddler

Tricycles Cause Almost 9500 Injuries a Year

2:00

The brightly colored, tripled wheeled tyke-bikes may appear pretty harmless, but tricycles injuries send thousands of children to the hospital every year according to a new study.

Researchers found that lacerations were the most common type of injury kids suffered.  

But in an indication that some kids might need more or better quality protective gear, researchers also estimated that about 30 percent of injuries were to the head and another 8 percent involved the elbow, noted lead study author Sean Bandzar.

“Head injuries in particular are very common with any kind of moving toy and that’s why we recommend helmets, and based on our findings I would also encourage parents to have kids wear elbow pads,” said Bandzar, a researcher at the Medical College of Georgia in Augusta.

Based on the 328 tricycle injuries reported by participating hospitals in 2012 and 2013, researchers estimated that there were about 9,340 injuries nationwide during the two-year study period.

The total included 2,767 injuries to the head and 767 at the elbow, as well as 1,880 accidents damaging the face, 954 hurting the mouth and 483 harming the lower arms, researchers estimated.

The study noted that on average, three year-olds were the typical age group injured and one to two-year olds, made-up slightly more than 50 percent of the cases.

Boys made up almost two-thirds of the cases.

With this age group, it came as no surprise that about 72 percent of the injures occurred at home.

There were a couple shortcomings of the study, the authors acknowledge in the journal Pediatrics, is that researchers lacked data on how accidents happened, whether kids wore helmets or other protective gear, what types of tricycles children rode and whether adults were present.

It’s also possible that the study didn’t have data on enough accidents to draw broad conclusions about tricycle injuries nationwide, said Dr. Gary Smith, president of the Child Injury Prevention Alliance and a professor of Pediatrics, Emergency Medicine and Epidemiology at The Ohio State University in Columbus.

“Tricycles are safe, especially if a few simple steps are taken to prevent injuries,” Smith, who wasn’t involved in the study, he told Rueters by email.

Children should always wear helmets any time they are on wheels above a hard surface – including tricycles, skateboards, scooters, skates and bicycles, Smith said. Tricycle riders in particular should only ride in areas separated from cars, and when parents can keep a close eye on them.

“Tricycles are somewhat riskier than other toys children use but that doesn’t mean they are highly risky toys,” said David Schwebel, a researcher at the University of Alabama at Birmingham.

While Schwebel, who wasn’t involved in the study, echoed the need for parental supervision, he also stressed that tricycles can be good for kids.

“Tricycles are valuable tools to help children develop critical gross motor skills like balance, coordination and strength,” Schwebel said by email. “Any tricycle, when used carefully in a supervised situation, is likely to be a positive activity for children.”

Source: Lisa Rapaport, http://www.reuters.com/article/2015/09/14/us-health-children-tricycle-injuries-idUSKCN0RE1TQ20150914

 

Your Toddler

More Small Children Poisoned by Detergent Pods

1:45

When detergent pods first became available, many families thought they were a convenient product for dishwashing and laundry. Grab a pod, pop it in and go. However, over time, warnings began to emerge that these colorful products proved too tempting to small children. The bright designs and little round shapes looked a lot like candy to toddlers and young children.

Even though the warnings have taken on a sense of urgency, a growing number of children are getting their hands and mouths on these products, with serious and sometimes fatal repercussions.

Among more than 62,000 calls made to emergency departments for poisoning from any kind of laundry or dishwashing detergent from 2013 to 2014, 17 children were in a coma, six stopped breathing, four had fluid in their lungs and difficulty breathing, and two died.

"Over 60 percent of these calls were due to laundry detergent packets," said lead researcher Dr. Gary Smith, director of the Center for Injury Research and Policy at Nationwide Children's Hospital, in Columbus, Ohio.

"That's about 30 children a day, or one child about every 45 minutes," he said. "Over the two years of the study, poisoning from detergent packets increased 17 percent, and in 2015 there was another 7 percent increase," Smith said.

Laundry detergent packets are more toxic than other forms of detergent and cause more hospitalizations and serious medical problems, Smith explained.

These packets look attractive to children, who could mistake them for food or candy, he said.

"All they have to do is put them in their mouth and bite down and the packet will burst, and once these toxic chemicals get down their throat the game's over," Smith added.

Given this growing problem, Smith said that parents of children under the age of 6 years should not have these products in the home. "They should use traditional detergents, which are far less toxic," he said.

Smith and colleagues analyzed data from calls made to U.S. poison control centers in 2013 and 2014 after unintentional exposures to laundry or dishwasher detergent involving children under the age of 6.

During those years, the number of poisonings increased for all types of detergents, but it was greatest for laundry detergent packets (17 percent), followed by dishwasher detergent packets (14 percent), the researchers found.

Smith noted that the liquid detergent were the most harmful to children.

Dr. Barbara Pena, research director in the emergency department at Nicklaus Children's Hospital in Miami, said companies have to do something to make these products safer.

People need to keep these products out of sight so children can't get into them, she said. "They should be treated just like medicine."

Ideally, parents of young children would not have them in the home, Pena said.

In response to the study, the American Cleaning Institute said Monday that manufacturers are working on a series of packaging and labeling steps that will be part of new international standards intended to reduce accidental exposure to the cleaning products.

The standards will include "secure package closures designed to challenge the typical strength, mental acuity and/or dexterity of a young child," the institute said in a news release.

There will also be first-aid instructions on the products' packages, the group said.

The report was published online in the journal Pediatrics.

It’s good that companies are researching safer packaging for their products, but ultimately, it’s up to the parents and caregivers of small children to make sure that their young child is safe from being poisoned by detergent pods.

Story source: Steve Reinberg, http://www.webmd.com/children/news/20160425/more-kids-being-poisoned-by-detergent-pods-study?print=true

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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