No More Benzocaine (Orajel, Anbesol and others) for kids!

Baby Orajel          Baby Anbesol

This week the FDA took a more firm approach to stopping the use of benzocaine-containing products in children.  Long sold as topical medicines for mouth pain such as teething and canker sores, these medicines are also known to cause an uncommon condition called methemoglobinemia.  In this condition, benzocaine reacts with the hemoglobin in a person’s red blood cells, preventing the uptake and transport of oxygen.  Symptoms can include blue or gray appearance of the face/lips, fingers, and mucous membranes.  As the blood can carry less oxygen, there is a risk of organ damage and suffocation.  The reaction can be immediate or can occur within several hours of medication use and can occur even with a tiny dose, even in people who have used the product safely in the past.

The small chance of developing methemoglobinemia while using benzocaine has long been known, and many doctors for years have recommended against using these medicines, but the FDA announcement goes further, and likely will be the end of these products for pediatric patients.  If a manufacturer continues to sell one of these products, the FDA states it would take “regulatory action”, but it is unlikely that anyone will continue making these products for pediatric use given the FDA’s clear and firm restriction.  Commonly sold brands include Orajel, Anbesol, Cepacol, and Hurricaine, as well as private-label versions.

The FDA has also in the past recommended against the use of homeopathic teething medications being sold as benzocaine alternatives, as some had been found to contain small amounts of some ingredients (including belladonna) that can cause neurological, respiratory, and musculoskeletal system complications, including potentially seizures.

Instead of using teething medication, the AAP recommends using hard rubber chew toys for babies and toddlers to gnaw on.  These can be kept cold (but not frozen) to help even more.  Use of acetaminophen or ibuprofen is not recommended as teething can last for a prolonged period of time and these medicines are not meant for chronic use.

The new restriction is for children only.  Adults can still use these products but likely there will need to be new safety warnings on the packaging.

 

Vaccine Side Effects

It has been said that pro-vaxers (i.e. docs, especially pediatricians), always talk about vaccine benefits and rarely about side effects.  I agree!  So today I want to talk about some of the side effects most commonly encountered with the routine vaccines we give to children.

Overall I think the reason that we accentuate the positive with vaccines is for 2 reasons: time and odds.  Time is the biggest reason, at least for me.  In my usual 15 minutes for a well visit, I need to take a history, discuss concerns, examine my patient, show parents growth charts, discuss any abnormal findings, AND then talk about labs and vaccines that are due.  As we already give out a Vaccine Information Statement (aka VIS) that lists individual vaccine side effects with each vaccine, most docs, me included, are a little fast and loose with discussing vaccine side effects in detail unless a parent has specific questions.

Odds are a different story.  Doctors are trained in thinking about risk:benefit ratios, making choices that serve the greatest good, and taking a global perspective of a patient’s health.  This means (I hope) that we presume that a parent will share our perspective of, say, the value of receiving a measles, mumps and rubella vaccine despite the pain of vaccination, the chance of rash and fever, and the small possibility of more severe side effects such as a febrile seizure.

Some side effects of vaccination are common to almost all vaccines given, while some are particular to a certain vaccine or when certain vaccines are given together.  Also, due to how side effects are monitored, almost any symptom might occur after a vaccine, whether it was an actual side effect or just a coincidence.  Some definite side effects are very serious but also very rare, which makes the vaccine “worth” giving to people in general although horrible for those who experience the severe side effect (see “odds” above).

So in no particular order, here is my take on some vaccine side effects.

Side effects of most most or all vaccines:

Pain: ok, I know this is obvious, but it’s also by far the biggest factor for all young children and lots of older ones as well.  Any injection is likely to cause pain although some kids seem not to care very much, even after the shot has been given.  Pain is most commonly present for up to a day or two after vaccination, at the site of the injection.  Pain meds like acetaminophen and/or ibuprofen work well.  If one is averse to medication, an ice pack can help.

Fever: also a biggie; timing varies by vaccine but commonly one should expect a fever in the 1-3 days following most vaccines.  The big exception is the measles vaccine (either MMR or MMRV), which can cause fever starting anywhere from 5-12 days after vaccination and can last several days from then.  Just like with pain, normally the best treatment for this is acetaminophen and/or ibuprofen.  Also you can consider cool cloths draped onto your child.  Do not try to put a child with a fever into a cold bath, because if he/she does have a febrile seizure (see below) that is the last place you want him or her to be, at risk for hitting the head or inhaling  bath water or both.

Fussiness: many children are more fussy in the day or two after a vaccine; often it is hard to tell if this is due to fever or pain or the vaccine itself

Rash: common after MMR and varicella (aka chickenpox) vaccines or the two combined as MMRV, rash usually happens in a similar time period as fever. There’s not much to do about it unless it itches, in which case a topical anti-itch medicine or moisturizing lotion may help.

 

 

More uncommon side effects:

Febrile seizure: this is an uncommon side effect but one that can occur after vaccination.  Febrile seizures usually occur as a child’s temperature is rising, and the is usually not any warning beforehand.  They are most common in children from 6 months to 5 or 6 years old, which is also an age range when lots of vaccines are given.  Thankfully, febrile seizures are usually very brief (under a minute) and almost always stop on their own.  If this occurs, after making sure the child is in a safe place (safe from falls, sharp objects and other dangers) you should call you child’s doctor but there is usually not much to do as the seizure is usually over before you reach anyone.  Of course, a prolonged seizure should prompt a call for an ambulance.  See below for a reference about this.  *It has been found that in 12-15 month olds, febrile seizures are more common when the MMR and varicella vaccines are given at the same time, so many doctors give them at different visits, say one at 12 months and the other at 15 months old.

 

Fainting: fainting, if it occurs, is most common in the 10-30 minutes right after a vaccination.  It seems to happen much more commonly with teens than with younger children.  The biggest worries are getting injured during a fall, especially head injuries.  Some people are prone to faint after vaccines, so with them a period of waiting while sitting down for 15 or 20 minutes after being vaccinated is advised.

 

A rare one but a big deal:

Guilian-Barre Syndrome: this is a rare but serious condition that usually occurs after infections but can also rarely occur after influenza vaccination.  It is a rapidly worsening tingling of nerves and weakness of muscles and can be life-threatening for some.  Again, rare but very serious.  People with a history of GBS are not given flu vaccine.

 

Whew!  That is a quick summary of some more common vaccine side effects.  There are many more as well, feel free to comment if you like.

 

 

This reference on measles-contains vaccines is from the CDC; it’s long but pretty comprehensive; with an excerpt below:

https://www.cdc.gov/mmwr/preview/mmwrhtml/00046738.htm

The following recommendations concerning adverse events associated with measles vaccination update those applicable sections in “Measles Prevention: Recommendations of the Immunization Practices Advisory Committee” (MMWR 1989; 38{No. S-9}), and they apply regardless of whether the vaccine is administered as a single antigen or as a component of measles-rubella (MR) or measles-mumps-rubella (MMR) vaccine. Information concerning adverse events associated with the mumps component of MMR vaccine is reviewed later in this document (see Mumps Prevention), and information concerning the rubella component is located in the previously published ACIP statement for rubella (18).

Side Effects and Adverse Reactions

More than 240 million doses of measles vaccine were distributed in the United States from 1963 through 1993. The vaccine has an excellent record of safety. From 5% to 15% of vaccinees may develop a temperature of greater than or equal to 103 F ( greater than or equal to 39.4 C) beginning 5-12 days after vaccination and usually lasting several days (19). Most persons with fever are otherwise asymptomatic. Transient rashes have been reported for approximately 5% of vaccinees. Central nervous system (CNS) conditions, including encephalitis and encephalopathy, have been reported with a frequency of less than one per million doses administered. The incidence of encephalitis or encephalopathy after measles vaccination of healthy children is lower than the observed incidence of encephalitis of unknown etiology. This finding suggests that the reported severe neurologic disorders temporally associated with measles vaccination were not caused by the vaccine. These adverse events should be anticipated only in susceptible vaccinees and do not appear to be age-related. After revaccination, most reactions should be expected to occur only among the small proportion of persons who failed to respond to the first dose. Personal and Family History of Convulsions

As with the administration of any agent that can produce fever, some children may have a febrile seizure. Although children with a personal or family history of seizures are at increased risk for developing idiopathic epilepsy, febrile seizures following vaccinations do not in themselves increase the probability of subsequent epilepsy or other neurologic disorders. Most convulsions following measles vaccination are simple febrile seizures, and they affect children without known risk factors.

An increased risk of these convulsions may occur among children with a prior history of convulsions or those with a history of convulsions in first-degree family members (i.e., siblings or parents) (20). Although the precise risk cannot be determined, it appears to be low.

Nasal spray flu vaccine (aka LAIV, or FluMist)

FluMist 5-pack     FluMist

Influenza prevention is getting more complicated, sort of. Until 15 years ago, the only way to prevent influenza was to get a flu shot in the fall and hope it would protect you from getting the flu.  The flu vaccine was grown in eggs and given annually.  Since then the options have expanded to include egg-free formulations, high-dose versions for older individuals, and a needle-free nasal spray.

In 2003 FluMist was approved for use  – a live attenuated influenza vaccine (LAIV) delivered as a spray into each nostril.  Intranasal administration made a lot of sense – this is the way that influenza virus enters the body and if we could create a barrier to entry, it would theoretically work better than waiting for the virus to enter the body before starting to fight it.  The big plus, of course, was that  it was not a shot.  This made it an immediate win with patients, especially kids.  For docs, it was faster to administer and easier to use – no needles, blood, bandages or sharps boxes.  Also, the back room management was easier, without need to draw fluid into a separate syringe.

However, although in some years the nasal spray vaccine worked well, there was a 2-year span when it seemed to work no better than a placebo.  Although there are differences of opinion as to why, with no evidence of protection, in 2016 the CDC had to pull its recommendation for use of this vaccine.  As a result, for the past 2 years, the only way to get vaccinated against influenza has been to get a shot.

For the influenza season starting in the fall (called the 2018-2019 flu season), FluMist is again on the list of possible vaccines for approval.  It will need to be approved based on data collected over the past 2 years, and although it’s not a sure thing, the CDC would certainly love to have a faster, painless product back in the office, and so would many patients.

Some basics about the nasal spray flu vaccine:

1. It is called FluMist (only 1 brand exists)

2. It is given as a tiny spray into each nostril

3. It is given in the same season that you would get any flu vaccine, August through May

4. It is approved for ages 2 years to 49 years (I’m too old for it now)

5. Many doctors are reluctant to use it in patients with asthma, as it makes an asthma exacerbation a little more likely in the few weeks after receiving it

6. It costs more than the cheapest injected flu vaccine but should be covered by insurance, including Medicaid, private insurance and government-provided insurance.


Usual Pediatric Schedule:

  • Can only be used in ages 2 years and older
  • Yearly dosing between August and May; earlier is better
  • Children receiving flu vaccine for first year ever get 2 doses, 1-2 months apart

Mumps Booster for College?

mumps neck swelling CDC

Photo above: a child with mumps (with swelling of the parotid glands in the neck)

 

There has been a lot of press in the vaccine community about recent outbreaks of mumps on college campuses.  This caused a debate over whether students should receive a booster of MMR vaccine prior to starting college.

The Facts:

1. In the U.S. children receive MMR vaccine routinely at 12-15 months old and again at 4-6 years old.

2. By college age most people are still protected (but not everyone).

3. Outbreaks of mumps are uncommon but they do happen.

4. Current CDC recommendation is to consider an MMR booster in people at high risk of exposure to mumps in consultation with local health authorities.  **This means that a graduating high school senior will NOT routinely need an MMR booster but it may be recommended if her/his college experiences an outbreak.  This vaccination would likely happen on campus.  This would be safe and would make sense.

5. Given medical privacy rules and the fact that most college students are over 18, families may or may not be notified of an event such as this (just like the fact that you will normally not get a copy of your child’s grades directly from the school).

Any thoughts???


Usual Pediatric Schedule:

  • 1st dose (as part of MMR vaccine) at 12-15 months old
  • 2nd dose (as part of MMR vaccine) at 4-6 years old

Vaccines and other Pediatric topics (but mostly vaccines)

 

Stethoscope graphic

Hi all – this is my first post on my new blog!  Will be adding something of substance in the next few days.  Hopefully everyone who finds their way here will either leave with new information, or (even better) leave something for the rest of us.

Marc Grella