Options During the Epinephrine Shortage

Of the medicines that you would hope that we would never run out of, epinephrine is probably on the top of the list for many people.

Unfortunately, many parents are still stuck dealing with shortages and delays of epinephrine injectors.

Why?

“The purpose of this letter is to inform you that in a very small number of cases, some EpiPen® 0.3 mg and EpiPen Jr® 0.15 mg Auto-Injectors, and their authorized generic versions, may not easily slide out of their carrier tube, which could delay or potentially prevent use of the device during an emergency.”

Dear Healthcare Provider Letter for Potential Label Defect of EpiPen Auto-Injectors and its Authorized Generic

For EpiPens, there was a problem with the labels on the injectors so that “in a very small number of cases, labels were not fully adhered to the surface of the auto-injector such that the device label may become stuck to the inside of the carrier tube.”

And for the Adrenaclick generic injectors, “Some lots of Epinephrine Injection auto-injector have passed all levels of inspection and met product specifications at the manufacturing facility, but have been found to contain particles upon further inspection.”

So both are now suffering from manufacturing delays after fixing these issues.

Luckily, most still have options for their kids with severe allergies.

Options During the Epinephrine Shortage

Can’t get your child’s prescription for epinephrine filled?

“Currently, EpiPen, EpiPen Jr and Adrenaclick remain in either a spot shortage or constrained supply.”

Alert – Epinephrine Shortage Update September 17, 2019

One of the first things to keep in mind is that the FDA has allowed for temporary extensions of expiration dates:

So check the NDC number and the original expiration date and see if you even need a refill yet.

The FDA has allowed for temporary extensions of expiration dates for some epinephrine injectors.

Next, know that many more versions of epinephrine are available than ever before!

If you can’t refill your child’s prescription because your pharmacy doesn’t have it, you might ask them which form of epinephrine they do have in stock, and then ask your pediatrician if you can use that version.

There are now six forms of epinephrine injectors available (with three that may be hard to find), including:

  • EpiPen, EpiPen Jr coupon – the auto-injector with the notorious reputation for the $670 retail price tag
  • Epinephrine injection (EpiPen, EpiPen Jr authorized generics) – coupon
  • Epineprhine injection (EpiPen, EpiPen Jr Teva manufactured generics) – coupon
  • Adrenaclick Adult, Child authorized genericcoupon – this is the epinephrine auto-injector that is available for $109.99 at CVS
  • SYMJEPI 0.3mg, 0.15mg – coupon – a new epinephrine pre-filled, ready-to-use device – not an auto-injector!
  • Auvi-Q – financial support – the epinephrine auto-injector that talks to you and has the notorious reputation for the $5,000 retail price tag

Whichever version you get, if you have commercial insurance without a high deductible, the coupon will likely cover your copay.

There are now six versions of epinephrine injectors available for children and adults with severe allergic reactions.
Can your pharmacy get you the Teva manufactured generic EpiPen or EpiPen, Jr?

And in a worst case scenario, if necessary, use an expired epinephrine injector, even if it is out of range of an extension, and seek immediate medical attention.

“If an in-date auto-injector is not available, it is better to use an expired auto-injector than to not give epinephrine.

Expired Epinephrine Can Still Save Lives

Still confused?

Hopefully you won’t be when you need to use your child’s epinephrine injector!

One very big issue with so many different types of epinephrine injectors is that their instructions for use are a little different.

“There are several different epinephrine auto-injectors available – Mylan EpiPen and Mylan Generic, Auvi-Q, and Adrenaclick; these auto-injectors have different steps for use.”

How to Use an Epinephrine Auto-Injector

We can also hope that once the shortages are resolved, a little competition will bring down the prices of all of these drugs, as even the generic EpiPens are at least $300!

More on Options During the Epinephrine Shortage

Does Zantac Cause Cancer?

Breaking News – Zantac syrup, made by Lannett, has been recalled too.

Have you heard the news that taking ranitidine (Zantac) could cause cancer?

I’d be surprised if you haven’t…

Does Zantac Cause Cancer?

So does Zantac really cause cancer or is this just media hype?

“The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

Ok, so Zantac might contain NDMA and NDMA could cause cancer.

But NDMA is found in many things, so how concerned should we be about it being in Zantac?

“Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”

FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

Although the FDA is still “evaluating whether the low levels of NDMA in ranitidine pose a risk to patients,” so far, it doesn’t sound like a very big concern.

While Novartis AG’s Sandoz division, which makes ranitidine, has stopped distributing their generic version of Zantac, Sanofi will continue to distribute brand name Zantac. And many other companies make ranitidine, so it will likely continue to be available.

Most companies are voluntarily recalling their prescription and over-the-counter versions of ranitidine tablets, capsules, and syrup.

How do medications become contaminated with NDMA?

In the case of blood pressure medications (sartans), regulators began looking for NDMA last year.

“It is now known that these impurities can form during the production of sartans that contain a specific ring structure known as a tetrazole ring under certain conditions and when certain solvents, reagents, and other raw materials are used. In addition, it is possible that impurities were present in some sartans because manufacturers had inadvertently used contaminated equipment or reagents in the manufacturing process.”

Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities

Ranitidine doesn’t contain a tetrazole ring, but as with the sartans, it is possible that the NDMA formed during production or that contaminated equipment or reagents were used in the manufacturing process.

“Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the “inherent instability” of the ranitidine molecule.”

Valisure Detects NDMA in Ranitidine

And food?

“The typical diet in most countries contains nitrates, nitrites, and nitrosamines. Nitrates and nitrites occur naturally in fruit and vegetables, which are regarded as an important part of a healthy diet due to the powerful evidence of beneficial health effects against cancer. In the same time, nitrates and nitrites are often used as food additives in processed meats such as ham, bacon, sausages, and hot dogs, to retard microbial spoilage, and preserve meat products recognizable appearance and flavor as well. A high consumption of processed meats is linked to an increased gastric cancer risk, and many people consider nitrates/nitrites as the main reason for that. Nitrosamines are produced by chemical reactions of nitrates, nitrites and other proteins.”

Song et al on Dietary Nitrates, Nitrites, and Nitrosamines Intake and the Risk of Gastric Cancer: A Meta-Analysis

NDMA is not in food because of contamination.

“…excess lifetime cancer risk was calculated separately for each of the five nitrosamines and then summed to arrive at a total excess lifetime cancer risk of 1.46 × 10-6 (or about 1 in 683,000) due to average population exposure to nitrosamines through pork bacon.”

Cancer Risk from Nitrosamines in Pork Bacon

And the cancer risk from NDMA in food is considered to be small.

“Nitrosamines are ubiquitous in the human environment and have been detected in food items, including cured meat, bacon, fish, and beer, in cosmetics, drugs, and in the front passenger areas of new cars.”

Exposure to high concentrations of nitrosamines and cancer mortality among a cohort of rubber workers

The bigger risk is likely from nitrosamines in cigarette smoke and occupational exposures.

What should you do if your child takes ranitidine?

Still, do you want to give your kids a medicine that might contain a substance that could cause cancer?

“The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”

FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine

Since the risk seems so small, whether or not you continue giving your child Zantac or you switch to something else might depend on how easy it would be to switch.

Over the counter Zantac is approved for adults and children 12 years and over. There are many options to treat reflux for these folks, including Pepcid, Prevacid, Nexium, and Prilosec, etc.

On the other hand, prescription ranitidine syrup is approved for infants as young as one-month-old. Not many medicines are approved at this age.

There is one though.

Although not an H2-receptor antagonists like ranitidine, Nexium is another reflux medicine that is approved for infants. It is a proton pump inhibitor (also decreases the production of acid in the stomach) that is available in delayed release oral suspension packets.

Should you stop taking Zantac?

So what should you do?

Although doing nothing or switching seem like your two options, if your child’s reflux has been well controlled on Zantac for awhile, this might be a good idea to ask your pediatrician if a trial off medications might be appropriate.

Most infants and children eventually outgrow having reflux and are able to wean off their reflux medicine. Is your child ready?

Of course, you shouldn’t stop your child’s medicine without talking to your doctor first. And instead of stopping their Zantac, it might be better to switch to another reflux medicine.

“Carcinogens do not cause cancer at all times, under all circumstances.”

American Cancer Society on Known and Probable Human Carcinogens

Could you keep taking Zantac? That’s also an option for now, especially if you only expect that your child will be on it for a short time, but as more manufactures declare that they will recall and stop shipping ranitidine, you might have to switch anyway.

Whatever you do, don’t panic over this news. Your kids are almost certainly not at any real increased risk to develop cancer just because they have been taking Zantac.

More on NDMA in Zantac

Updated: October 30, 2019

ADHD Medication List

Remember when we only had Ritalin, Adderall, and Dexedrine to treat kids with ADHD?

Know how many medications there are now?

Are All of the ADHD Medications Very Different?

Although there are a lot of different ADHD medications to choose from now, including some non-stimulants, it is important to realize that most of the stimulants are basically just different formulations or derivatives of Ritalin, Adderall and Dexedrine.

In fact, in many cases, it isn’t the ingredient that is different, but rather the delivery system.

Are your kids taking a short acting stimulant, that only lasts four or five hours? Or are they taking an extended release ADHD medication, that might last 8 to 16 hours? And if taking an extended release stimulant, are they simply taking one that mimics taking a short acting drug twice a day, releasing half of the medication immediately and another half 5 to 6 hours later? Or is it some other percentage on a longer, extended time release throughout the day, like the OROS time release system of brand name Concerta.

  • Adderall – mixed amphetamine salts – immediate release – lasts 4-6 hours – 5 to 30mg tablets
  • Adderall XR – mixed amphetamine salts – extended release with a 50/50 time release schedule – lasts 8-12 hours – 5 to 30mg capsules
  • ADHDnsia XR – methylphenidate – extended release
  • Adzenys ER – amphetamine – extended release liquid
  • Adzenys XR-ODT – amphetamine – extended release orally disintegrated tablets
  • Aptensio XR – extended release with a 40/60 time release schedule
  • Concerta – methylphenidate – extended release with a 22/78 time release schedule (OROS)
  • Cotempla XR-ODT – methylphenidate – extended release with a 30/70 time release schedule
  • Daytrana – methylphenidate patch – extended release
  • Dexedrine – dextroamphetamine – immediate release
  • Dyanavel XR – amphetamine – extended release
  • Evekeo – amphetamine – immediate release
  • Focalin – dexmethylphenidate – immediate release
  • Focalin XR – dexmethylphenidate – extended release with a 50/50 time release schedule (SODAS)
  • Jornay PM – methylphenidate – extended release
  • Metadate CD – methylphenidate – extended release with a 30/70 time release schedule
  • Metadate ER – methylphenidate – extended release with a 50/50 time release schedule
  • Methylin – methylphenidate – immediate release
  • Methylin ER – methylphenidate – extended release
  • Methylphenidate ER – methylphenidate – extended release
  • Mydayis – amphetamine salt combo – extended release
  • Quillichew ER – methylphenidate – extended release with a 30/70 time release schedule
  • Quillivant XR – methylphenidate – extended release with a 20/80 time release schedule
  • Vyvanse – lisdexamfetamine – extended release with a 50/50 time release schedule
  • Ritalin – methylphenidate – immediate release
  • Ritalin LA – methylphenidate – extended release with a 50/50 time release schedule (SODAS)
  • Ritalin SR – methylphenidate – extended release
  • Zenzedi – dextroamphetamine – immediate release

Do we really have over 25 different ADHD stimulants to choose from now?

Distinctions Without a Difference

Well, kind of.

For one thing, our choices of ADHD drugs to prescribe become much more limited once you realize how expensive these new medications can be, even if you try and use a drug coupon.

Price is a big difference on this ADHD medication list.
Price is a big difference on this ADHD medication list.

And again, our choices aren’t as big once you realize that most are really just different formulations or derivatives of Ritalin, Adderall and Dexedrine.

Can’t afford a newer ADHD medication for your child? Understand that many of these newer medications don’t actually offer all of that much benefit over older, less expensive medications.

Do you really need a liquid, chewable or ODT medication when most ADHD extended release capsules can be opened and sprinkled on food?

More on ADHD Medication List

Follow These Social Media Doctors Fighting Medical Misinformation

I often hear that we need more doctors on social media fighting medical misinformation.

You know what the real problem is?

There aren’t enough folks following the doctors who are on social media fighting medical misinformation…

Where Are the Social Media Doctors Fighting Medical Misinformation?

Sure, more would likely be better, but you can’t get past the simple fact that those pushing quackery and medical misinformation can easily attract huge followings on Instagram, Facebook, and Twitter.

Your friendly pediatrician (tweetiatrician) combating that medical misinformation?

Not so much…

Is that because most of us like writing more than fighting for likes?

Probably.

It’s also likely a function of the simple fact that fake facts are more interesting than real facts.

Follow These Social Media Doctors Fighting Medical Misinformation

So know that you know that they exist, where are these doctors fighting medical misinformation and which ones should you follow?

Here are some to get you started.

David Gorski is one of the social media doctors who is fighting medical misinformation who is active on Twitter.

Gorski has been writing about medical misinformation on the Internet since before there was an Internet.

If you aren’t reading his blog Respectful Insolence, then you likely don’t know why quackademic medicine is such a problem, you may not have been aware of all of the players who have been scamming pushing complementary and alternative medicine over the years, and you might have never heard of misinformed consent. He is also active on Science Based Medicine, where he is a managing editor.

Like David Gorski, Steven Novella has been writing about pseudoscience for a long time, first at the NESS (the New England Skeptical Society) and then at The Skeptics’ Guide to the Universe, Neurologica, and Science-Based Medicine.

Are you following them?

Jennifer Gunter is one of the more popular social media doctors fighting medical misinformation.

Jennifer Gunter may be best known for calling out Gwyneth Paltrow’s Goop and her jade vaginal eggs, vaginal steaming, and other quackery. Active on Twitter, she also has a column in the New York Times, has a new book coming out, The Vagina Bible (pre-order it now!), and she is getting her own TV show!!!

She is another doctor you should be following, as she is doing a great job of calling out non-evidence based treatments.

And then there are these folks you should be reading and following (no, they are not all doctors…):

That they all don’t have millions of followers is one of the reasons that folks fall for medical misinformation is so easily.

It’s the reason that you might go to a chiropractor when you are having problems breastfeeding, even though you don’t really understand how chiropractic works.

And why you buy homeopathic “medicines” when your kids have colic or a runny nose, not understanding that you don’t get any active medicine when you buy something with homeopathy on the label.

From misinformation about vaccines to every type of alternative medicine scam out there, these folks have been writing and warning us about them for a long time.

Surprised when someone “breaks a story” about celebrity anti-vaxxers or the “latest” alternative medicine fad that is hurting folks? You wouldn’t be if you were following these folks fighting medical misinformation.

More on Social Media Doctors Fighting Medical Misinformation

The New Vaccine Surveillance Network Report on Enterovirus D68 Infections

Anyone who has been following the outbreaks of Acute Flaccid Myelitis the last few years will likely think the following report is long overdue.

The report, Enterovirus D68–Associated Acute Respiratory Illness — New Vaccine Surveillance Network, United States, July–October,2017 and 2018, is especially welcome by those folks who are already convinced that AFM is associated with EV D68.

The New Vaccine Surveillance Network Report on Enterovirus D68 Infections

But wait, why was surveillance done through the New Vaccine Surveillance Network?

And for that matter, what is the New Vaccine Surveillance Network?

“The New Vaccine Surveillance Network (NVSN) includes study sites that focus on population-based surveillance and data collection on the use and impact of vaccines and the impact of vaccine policies. Since 2006, NVSN sites have conducted active, population-based surveillance for hospitalizations and outpatient visits associated with acute gastroenteritis (AGE) in children (2006-present). NVSN sites have conducted surveillance for acute respiratory illness (ARI) from 2000 to 2009, and again beginning in 2015.”

New Vaccine Surveillance Network (NVSN)

Before you start thinking that this means a new Enterovirus D68 vaccine is coming out soon, many NVSN studies have nothing to do with vaccines…

“NVSN supports broad-based surveillance and research projects for acute gastroenteritis and acute respiratory infections in areas with a population base of at least 500,000.”

New Vaccine Surveillance Network (NVSN) Overview

In addition to studies on the flu and pneumococcal disease, they have done studies on norovirus, coronavirus, human metapneumovirus, HPIV, RSV, and rhinovirus infections.

So what did they find out about Enterovirus D68 infections?

“Based on preliminary data, test results were positive for EV-D68 for two (0.08%) of 2,433 patients with ARI who were tested during 2017 and 358 (13.9%) of 2,579 tested during 2018. “

Enterovirus D68–Associated Acute Respiratory Illness — New Vaccine Surveillance Network, United States, July–October, 2017 and 2018

There were a lot more EV D68 infecions in 2018 than there were in 2017

And what does that mean?

Considering that we had “only” 33 confirmed cases of AFM in 16 states in 2017 and at least 223 confirmed cases of AFM in 41 states in 2018, the rise in EV-D68 cases seems to correlate with the rise in AFM.

“Although AFM is rare in the United States, these AFM surveillance data, along with the EV-D68 activity documented through NVSN, provide additional supporting evidence for a temporal association between EV-D68 respiratory illness and AFM. “

Enterovirus D68–Associated Acute Respiratory Illness — New Vaccine Surveillance Network, United States, July–October, 2017 and 2018

Again, few people are going to be surprised by this news…

So, what’s next?

You mean besides the 2019 AFM season?

More on Acute Flaccid Myelitis News


Infants’ Ibuprofen Concentrated Oral Suspension Recall

Three lots of  Infants' Ibuprofen Concentrated Oral Suspension that were made by Tris Pharma, Inc. and sold under the Equate, CVS Health, and Family Wellness brands and sold at Wal-Mart, CVS, and Family Dollar stores have been recalled.

If you have little kids who sometimes take pain or fever medications, you will want to check your medicine cabinet for this recall.

Three lots of Infants’ Ibuprofen Concentrated Oral Suspension have been recalled because the concentration in the bottle might be higher than they it is supposed to be.

What does that mean?

Although they are supposed to be at a 50mg per 1.25ml concentration, if it is indeed higher, then if you gave your child 1.25ml, they might get more than just 50mg.

“To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.”

How much more? We don’t know, since we don’t know what the “potentially” higher concentration might be.

Infants’ Ibuprofen Concentrated Oral Suspension Recall

Fortunately, the recall is limited to just 3 lots of  Infants’ Ibuprofen Concentrated Oral Suspension that were made by Tris Pharma, Inc. and sold under the Equate, CVS Health, and Family Wellness brands and sold at Wal-Mart, CVS, and Family Dollar stores.

Do you have any recalled Ibuprofen?
Do you have any recalled Ibuprofen? Check your lot numbers!

If you have the recalled Ibuprofen, don’t use it. Contact Tris Pharma for a refund.

And seek medical attention if you think your child got too much Ibuprofen and is having any symptoms, especially nausea, vomiting, epigastric pain, or more rarely, diarrhea.

Fortunately, getting extra Ibuprofen is not usually as dangerous as getting extra Acetaminophen.

Although, of course, neither is good! Be careful when dosing your kids and be sure they need it first.

Oh, and yes, at least in this case, store brand Ibuprofen at Family Dollar and Wal-Mart is the same as store brand Ibuprofen at CVS…

More on Infants’ Ibuprofen Concentrated Oral Suspension Recall