Author: Vincent Iannelli, MD

Does Zantac Cause Cancer?

Breaking News – In Canada, companies marketing ranitidine products have stopped any further distribution until evidence is provided to demonstrate that they do not contain NDMA above acceptable levels.

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.

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 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

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

Does My Child Need a Flu Test?

Your child has a fever, cough, runny nose, body aches and chills.

Should you rush them to your pediatrician for a flu test?

Diagnosing the Flu with a Flu Test

While you may want to seek medical attention, depending on your child’s age and how sick they are, believe it or not, you don’t need a flu test to get diagnosed with the flu.

“If your doctor needs to know for sure whether you have the flu, there are laboratory tests that can be done.”

CDC on Diagnosing Flu

A flu test is an option though.

Most people do not need a flu test.
Most people do not need a flu test.

Is it a good option?

A necessary option?

“Most people with flu symptoms are not tested because the test results usually do not change how you are treated.”

CDC on Diagnosing Flu

While a diagnosis of the flu can be made clinically, based on your symptoms, a flu test can be a good idea:

  • to help determine the cause of an outbreak (mostly if there aren’t already a lot of flu cases in your area)
  • if someone is at high risk for flu complications

In general though, most people do not need a flu test, especially during the active part of flu season.

What’s the problem with doing a flu test?

“In January 2017, the FDA reclassified antigen-based RIDT systems into class II. This reclassification was to help improve the overall quality of flu testing. The reclassification was prompted, in part, by recognition that the poor sensitivity of some of antigen-based RIDTs resulted in misdiagnosed cases, and, according to anecdotal reports, even death.”

FDA on CLIA-Waived Rapid Flu Test Facts

Mostly, they are neither as accurate nor as easy to interpret as most folks think, even the newer versions of these tests.

Have you ever heard someone say that they tested positive for both flu A and flu B?

When a flu tests is positive for both A and B flu strains, it invalidates the test. They may have had either flu A or flu B or neither, but they almost certainly didn’t have both.

The antigen-based rapid flu tests that most doctors and clinics use, which give results in 10 or 15 minutes, are also prone to both false positive (you don’t really have the flu, even though your test was positive), and more commonly, false negative (you actually do have the flu, even though your test was negative) results, depending if flu is active at the time.

Other flu tests are available, but are more expensive and take longer to get results, so aren’t used as often. These include “rapid” nucleic acid detection based tests that can be done in a doctor’s office, rapid nucleic acid detection based tests and rapid influenza diagnostic tests that are done in a central lab, PCR tests, and viral cultures.

So why do so many people rush to the doctor to get a flu test?

Many think that if they are positive, then they can take Tamiflu or another flu medicine and get better faster.

The problem with thinking like that is that few people actually need to take Tamiflu, as at best, it only helps you get better about a day quicker than if you didn’t take it. That’s why the recommendations for Tamiflu say to reserve it for children under two to five years of age and others who might be at high risk for flu complications.

Since most other people don’t need to take Tamiflu, they don’t necessarily need a flu test or a definitive diagnosis of the flu. Again, even if they did need Tamiflu, the diagnosis of the flu could be made clinically.

And even more importantly, a negative flu test doesn’t necessarily mean that you don’t really have the flu, especially if you have classic flu symptoms in the middle of flu season. Again, a negative flu test could be a false negative.

“RIDTs may be used to help with diagnostic and treatment decisions for patients in clinical settings, such as whether to prescribe antiviral medications. However, due to the limited sensitivities and predictive values of RIDTs , negative results of RIDTs do not exclude influenza virus infection in patients with signs and symptoms suggestive of influenza. Therefore, antiviral treatment should not be withheld from patients with suspected influenza, even if they test negative.”

CDC on Guidance for Clinicians on the Use of Rapid Influenza Diagnostic Tests

Have you ever had a negative flu test and the doctor still gave you Tamiflu? Then why did they do the test?

Diagnosing the Flu Without a Flu Test

If the results of flu testing aren’t going to change how you are treated, then you probably don’t need to have the flu test done in the first place.

Plus it saves you from having a swab stuck up your nose.

But kids should have flu tests, right?

Although rapid flu tests might be a little more accurate in kids than adults, it is not by much, so you are left with the same issues.

A positive test might reassure you that it really is the flu, but your child could still have the flu if their test is negative. A diagnosis and treatment decision can be made clinically, without a flu test, remembering that most older, healthy kids don’t need to be treated with Tamiflu.

We can’t skip flu season (although we sure can try if we get vaccinated and protected), but we can try and skip flu testing season.

More on Flu Tests