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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

Your Teen

FDA to Regulate E-cigarettes, Raise Age for Purchasing

2:00

Cigarette smoking among teens and young adults has been on a slight decline in the past few years, but e-cigarette use has been rapidly increasing.

Because there are no regulations and scant information on the products used to fuel e-cigarettes, many leading health organizations, including the American Academy of Pediatrics have been urging the Federal Drug Administration (FDA) to bring e-cigarettes and liquid nicotine under its authority.

The U.S. government has responded and taken action. The FDA issued a tough set of rules for the e-cigarette industry that included banning sales to anyone under 18, requiring package warning labels, and making all products—even those currently on the market—subject to government approval.

For many teen and health organizations, the ruling has been long overdue.

Though the product-approval process will be phased in during three years, that will be little solace to the fledgling but fast-growing $3.5 billion industry that has, until Aug. 8 when the rules take effect, largely been unregulated and dominated by small manufacturers and vape shops.

Many of the vape shops, device manufacturers and liquid nicotine producers are not happy with the change.

“This is going to be a grim day in the history of tobacco-harm reduction,” said Greg Conley, president of the American Vaping Association, an industry-funded advocacy group. “It will be a day where thousands of small businesses will be contemplating whether they will continue to stay in business and employ people.”

In June, the FDA proposed requiring warning labels and childproof packaging because of an increase in nicotine exposure and poisoning incidents. The agency could move to regulate advertising or flavors such as cotton candy and watermelon that also might appeal to youth.

“We’re looking at the flavor issue with e-cigarettes,” said FDA Tobacco Center Director Mitch Zeller during a news conference. Later, he said, that while the agency was aware of “anecdotal reports” that e-cigarettes have helped smokers kick their habit; those benefits were outweighed by concerns about youth using the devices.

E-cigarettes are not the only tobacco related products that will come under the control of the FDA. Unregulated tobacco items, including pipe tobacco and water-pipe tobacco, will also fall under the supervision of the FDA.

The FDA has been regulating cigarettes since Congress granted it oversight of traditional smokes with the 2009 Family Smoking Prevention and Tobacco Control Act.

“Today’s announcement is an important step in the fight for a tobacco-free generation—it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions,” Department of Health and Human Services Secretary Sylvia Mathews Burwell said in a statement.

Most researchers agree e-cigarettes are less harmful than cigarettes because, unlike cigarettes, they don’t combust. Studies have shown that when traditional cigarettes combust they release more than 60 carcinogens. But the long-term effects of using the electronic devices remain largely unknown, and many anti-tobacco groups and public health officials are concerned they could become a gateway to traditional smoking.

Anti-tobacco groups have been frustrated with FDA, saying the agency has taken far too long to finalize its rules.

Concerns escalated when a study published in August by the Journal of the American Medical Association found ninth-graders who used e-cigarettes were 2½ times as likely as peers to have smoked traditional cigarettes a year later.

The Centers for Disease Control and Prevention reported in April that e-cigarette use tripled among U.S. teenagers in 2014.

The AAP issued its recommendations on tobacco and e-cigarettes in late 2015.

In a press release, the organization said it strongly recommends the minimum age to purchase tobacco products, including e-cigarettes, should be increased to age 21 nationwide.

"Tobacco use continues to be a major health threat to children, adolescents and adults," said Karen M. Wilson, MD, MPH, FAAP, chair of the AAP Section on Tobacco Control and section head of Pediatric Hospital Medicine at Children's Hospital Colorado. "The developing brains of children and teens are particularly vulnerable to nicotine, which is why the growing popularity of e-cigarettes among adolescents is so alarming and dangerous to their long-term health."

Under the new rules, e-cigarette manufacturers would have up to two years to continue to sell their products while they submit an application to the FDA.

Story sources: Tripp Mickle, Tom Burton, http://www.wsj.com/articles/fda-to-regulate-e-cigarettes-ban-sales-to-minors-1462455060

https://www.aap.org

 

Daily Dose

Water Safety

1:15 to read

I was reminded of the importance of pool safety after watching the news and hearing that 3 children were found in a nearby apartment pool, under water and unresponsive.  

There are about 3,500 fatal unintentional drownings per year, which is about 10 deaths per day.  Drowning is the second leading cause of death in children ages 1-14 years.  For every child who dies from drowning, there are 4 non-fatal drowning victims who suffer severe and life changing injuries.

Drowning is preventable!!  Although many people think of drowning victims screaming and yelling, drowning is actually quick and silent.  It only takes seconds (the time to grab a towel, or answer the phone) and a child may become submerged. Most drownings also occur in family pools.  Because I have always had a fear of drowning we did not build a pool until our boys were all older than 10 years and were excellent swimmers ( was I a bit over zealous with swim lessons and swim team, maybe...)?  Children as young as 2-3 years can safely begin swim lessons and begin the process of mastering how to tread water, floating and basic swim strokes. 

Another rule for safe swimming is “never swim alone!”.  Teach your children the importance of the buddy system when they are swimming, even in a backyard pool. Adults need to be designated “water watchers” and know that they are responsible for watching the children in the pool and will never leave them unattended. The “water watcher” should regularly scan the bottom of the pool, and will need to have a phone at the pool for emergency use only.  Adult water watchers have only 1 job...to watch the pool, no poolside chatting or distractions. It is a big job!

Anyone with a pool or who is a caregiver of children who are swimming needs to become CPR certified.  CPR skills can save lives and prevent brain damage.   

Lastly, if you have a pool you need layers of protection - which  means a barrier around your pool. I have heard many a family tell me that their child “could never get out the door to the pool, it has several locks and an alarm”.  Despite the best of intentions, no parent can watch their child 24 hours/day.  Toddlers have been known to push a stool over to unlock a door, or a door is inadvertently left unlocked or ajar. Remember, it only takes seconds for a child to become submerged. 

By the way, I am following my own advice and a pool fence is going up to protect our granddaughter...the bigger the better.

Daily Dose

Importance of Booster Seats

The Texas Legislature is sending a bill to Governor Rick Perry that will change booster seat laws. The current law requires that children under five years of age and 3 feet 9 inches tall be in a car seat. The new law will require that children under the age of eight years or 4 feet 9 inches tall be restrained in a car seat. Car accidents are the leading cause of death for children in this age group and experts testified that changing the booster seat law would reduce the risk of life threatening injury by up to 60%.

The extra height provided by a booster seat allows the seat belt to be positioned correctly, across the child's pelvis. Without the booster the seat belt is often placed across the child's abdomen or neck, or even behind the shoulders and neck and puts them at risk for head, neck and abdominal injuries. Correct positioning of the belt is essential for maximum protection. Forty other states have similar laws requiring booster seat use. This bill will not go into effect in Texas until 2010, but don't wait until then to get your child a booster seat. Many parents already have their children in booster seats, but if not, put this at the top of your "to do list". If your children balk at the idea, tell them that it is for their protection and it is now a law! That's your daily dose, we'll chat again tomorrow.

Your Baby

Britax Recalls Car Seat Chest Clips Due to Infant Choking Hazard

1:30

Faulty chest clips on more than 100 models of Britax Care Safety car seats are being voluntarily recalled because the clips could break off and create a choking hazard for infants.

The company says that no injuries have been reported, but it has received complaints of chest clips breaking.

The recall will affect more than 200,000 car seats. However, Britax stresses that the car seats are still safe to use until a replacement kit is obtained. 

The chest clip is on the Britax B-Safe 35, B-Safe 35 Elite, and BOB B-Safe 35 infant seats.

The products were manufactured between Nov. 1, 2015, and May 31, 2017. To see the model numbers that are included in the voluntary recall, or to check the serial number of your seat, visit the company’s website set up for this recall at www.bsafe35clip.com. You can find the serial numbers on the "Date of Manufacture" label on the lower frame of the seat.

Britax is offering to replace the chest clip with a free kit that contains a new clip made from a different material. The kit comes with step-by-step instructions for replacement. Consumers are advised to routinely check their current chest clip until a replacement arrives.

Story sources: Alexandria McIntire, http://www.webmd.com/children/news/20170623/recall-britax-car-seat-chest-clip

Ashlee Kieler, https://consumerist.com/2017/06/21/britax-recalls-207000-carseats-over-chest-clips-that-can-break/

Daily Dose

Uber & Teens

1:30 to read

Do you have Uber cars in your area?  I first found out about Uber (and I am only using them as an example) when my son lived in NYC and often used the car service. Later on I heard about college kids using Uber as well.  In that case, many college kids did not have cars and/or they were being “responsible” after being at a party.

But recently, in conversations with my adolescent patients, I have heard that high school kids are using Uber to come home after a party, or other social activities. In otherwords, their parents are not picking them up from the dance, concert, or party but are letting their children (often young girls) call Uber.  Where are their parents and what are they thinking?

I realize that once your child heads off to college you hope and pray that they are making good choices and are being safe. You don’t really plan on picking them up after an event or talk to them that same night about what they have been doing and with whom.  But when we had high school age children, my expectations were that we, the parents, were responsible for taking our teens to the party and to pick them up. Once they were driving the “rules” changed a bit in that they were then often driving themselves to an event and then would drive home and we would be up waiting for them to get home.  They always knew that we would be there when they got home and also that if there were any “issues” we were also available to pick them up. We talked a lot about underage drinking as well as driving and responsibility.  Never did I think they would call a cab or car service, nor was that idea ever broached, they were to call their parents.

So now that these “app” car services are available around the clock, are parents abrogating their responsibilities for parenting teens?  By allowing their teens to call a car service for their ride home, are parents seemingly not interested in where their child has been or who they have been with or what they have been doing before they get home?  You certainly can drop your child at a concert or party and tell them to text Uber to get a ride home, but does this parental non-participation quietly help to condone inappropriate, risky, teen behavior?

Although picking your child up at the end of the evening or checking on them when they pull in the driveway will never ensure that your teen does not get into trouble, I think it does help them think a bit more about having to interact with their parents at curfew time. This “worry” might help lead them to make a better decision about drugs, alcohol or whom they are hanging out with. Putting teens into the “hands” (cars) of strangers as their ride home just seems wrong. Parents be aware. 

Daily Dose

Vaccine Safety

The MMR (measles, mumps and rubella) vaccine and Varivax (chickenpox) vaccine have both been licensed and recommended for many years. These vaccines are typically given to children between the ages of 12-15 months, and then again between 4-5 years.

In 2005, a new vaccine was released which combined MMR and Varivax  (MMRV) which reduced the number of needle sticks a child would receive from their routine immunizations. Vaccine safety is always a paramount concern and even after a vaccine is FDA approved there continues to be “post licensing” monitoring of the vaccine, looking for any reported adverse events. After the release of MMRV in 2005, there were noted to be an increase in the number of febrile seizures occurring within 10 days of receiving the combination vaccine.  As a result, the use of this combination vaccine was suspended in 2008 and then resumed in early 2010. A study released in the July issue of Pediatrics now looks at the vaccine safety data that was accumulated on MMRV post licensure,  and analyzed data on over 459,000 children who had been vaccinated between 2000 and 2008. In the retrospective study, 83,000 children received MMRV and 376,000 with separate MMR and Varivax vaccines. The study found that children between the ages of 12–23 months have about double the risk of developing a febrile seizure 10 days after receiving MMRV than those children that received separate MMR and Varicella vaccines. MMRV vaccination was associated with an estimated 4.3 additional seizures per 10,000 doses during the 7–10 days post vaccine. As discussed in previous blogs, febrile seizures are fairly common and are typically harmless to a child, but cause a lot of anxiety and fear for parents.  (my own son had a febrile seizure as a toddler).  The American Academy of Pediatrics endorses the use of single or combination vaccine for MMR and Varivax. The fact that there may be a greater likelihood (albeit small) for a child to develop a febrile seizure post MMRV vaccination needs to be discussed with parents as there is not going to be a “right” answer as to vaccine preference. Some parents would prefer minimize needle sticks and would opt to receive MMRV, while others would prefer to have MMR and Varivax given separately to minimize any risk of  an adverse event. Due to the fact that the increased seizure risk was seen in children between 12-23 months, one might advocate to use the separate vaccines for the initial series and the combination vaccine in the older child (who would probably vote to get one less STICK). Protecting against measles, mumps, rubella and chickenpox is the most important issue at hand.  Discuss the pros and cons of the combination vaccine with your own doctor, but be reassured that vaccines are continually being monitored for safety as well as efficacy. That's your daily dose for today.  We'll chat again tomorrow. Send your question to Dr. Sue.

Your Baby

“Hard” Tap Water and Eczema in Infants

1:30

Previous studies have noted an association between “hard” tap water and eczema in schoolchildren, but a new study out of the U.K. suggests it may be linked to eczema in babies as well.

Water described as “hard” contains a high degree of minerals - specifically calcium, magnesium and manganese. It’s not considered hazardous, but it comes with a variety of unpleasant effects such as soap scum in sinks and bathtubs, spots on dishes and shower glass, clogged pipes from buildup and clothes that are left dingy after washing.

By some accounts, 85% of U.S. households have hard water.

If your child has eczema, then you know that it is a chronic condition marked by itchiness and rashes. It typically starts at about 6 months old and can last into adulthood.

The study included 1,300 3-month old infants from across the United Kingdom. Researchers checked hardness -- the water's mineral content -- and chlorine levels in the water supply where the babies lived.

Babies who lived in areas with hard water were up to 87% more likely to have eczema, the study found.

"Our study builds on growing evidence of a link between exposure to hard water and the risk of developing eczema in childhood," said lead author Dr. Carsten Flohr, from the Institute of Dermatology at King's College London.

One way to change the composition of hard water is by adding a water softener system to your household

There are several types of systems including salt-based Ion exchange softeners, salt-free softeners, dual tank and magnetic water softeners plus others.

While the other studies focused on school aged children, this is the first to look at the connection with eczema, hard water and babies, the researchers said.

The study wasn't designed to prove a cause-and-effect relationship, so further research is needed to learn more about this apparent link, Flohr added.

"We are about to launch a feasibility trial to assess whether installing a water softener in the homes of high-risk children around the time of birth may reduce the risk of eczema and whether reducing chlorine levels brings any additional benefits," Flohr said in a college news release.

The study was published recently in the Journal of Allergy and Clinical Immunology.

Story sources: Robert Preidt, https://www.nlm.nih.gov/medlineplus/news/fullstory_159150.html

http://extoxnet.orst.edu/faqs/safedrink/hard.htm

 

 

Your Baby

Recall: Oball Baby Rattles Due to Choking Hazard

1:30

About 680,000 Kids ll Inc. Oball baby rattles have been recalled due to choking hazards.

This recall involves Oball Rattles in pink, blue, green and orange with model number 81031 printed on the inner surface of one of the plastic discs and on the packaging. The balls have 28 finger holes and measure four inches in diameter.

Embedded in the rattles are a clear plastic disc with all orange beads and two clear plastic discs with beads of varying colors on the perimeter.

Only rattles with date codes T0486, T1456, T2316, T2856 and T3065 located on a small triangle on the inner surface of the rattle are included in the recall.

The first three numbers represent the day of the year and the last digit represents the year of production.      

The firm has received 42 reports of the plastic disc breaking releasing small beads including two reports of beads found in children’s mouths and three reports of gagging.

Consumers should immediately take these recalled rattles away from young children and contact the firm to receive a full refund.

The rattles were sold at Target, Walgreens, Walmart and other retailers nationwide and online at Amazon.com, Babyhaven.com, Diapers.com, ToysRUs.com, Walgreens.com and other online retailers from January 2016 through February 2017 for between $5 and $7.  

Consumers can contact Kids II toll-free at 877-243-7314 from 8 a.m. to 5 p.m.  ET Monday through Friday or visit www.kidsii.com and click on “Recalls” at the bottom of the page for more information.

Story source: https://www.cpsc.gov/Recalls/2017/Kids-II-Recalls-Oball-Rattles

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DR SUE'S DAILY DOSE

When should you get your flu shot?

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