Zantac 360 is Not Zantac

Recently the FDA has allowed Zantac to be relaunched as Zantac 360. This is well-described in a recent blog post on GoodRx: Zantac Returns to Market With a New Ingredient

While famotidine (the new ingredient in Zantac 360) acts similar to ranitidine (the old ingredient), there is no longer N-nitrosodimethylamine (NDMA) detectable which was a concern as a potential cancer risk. It comes in two different strengths (10 mg and 20 mg).

My take: In my view, it is a bad decision to allow Zantac to be relaunched with this new ingredient; this is like allowing some hot dogs to be sold as hamburgers.

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Most Popular 2020 Posts

I want to thank all of you who take an interest in my blog, particularly those who give suggestions, references, and encouragement. The following posts were the most popular from the past year.

Related post: Favorite Posts of 2020

Sandy Springs at Sunrise

Use of Famotidine for COVID-19

A recent study (DE Freedberg et al. Gastroenterol 2020; DOI: Use Is Associated With Improved Clinical Outcomes in Hospitalized COVID-19 Patients: A Propensity Score Matched Retrospective Cohort Study, highlighted on AGA blog, indicates that famotidine may improve outcomes in those with COVID-19.

Methods: Freedberg et al collected data from 1620 patients who tested positive for SARS-CoV-2 no more than 72 hours following admission; 84 of the patients (5.1%) had received famotidine (any dose, form of administration, or duration; median dose of 136 mg) within 24 hours of hospital admission.

Key finding: After the authors adjusted for baseline patient characteristics, use of famotidine was independently associated with risk for death or intubation (adjusted hazard ratio 0.42, 95% CI, 0.21–0.85). This did not change after propensity score matching to balance covariables (hazard ratio 0.43, 95% CI 0.21–0.88).

My take: While these results indicate that famotidine may improve outcomes with COVID-19, a randomized controlled trial is needed to confirm these findings (currently one is underway to determine whether famotidine can improve clinical outcomes in hospitalized patients with COVID-19 (NCT04370262)).

AGA Blog Summary: Use of Famotidine Associated With Improved Outcomes of Hospitalized COVID-19 Patients

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COVID-19: At-Risk Populations, Moral Distress, and Related News

Before today’s post –more on voting this year:

Democracy Docket Four Ways to Safely Cast Your Ballot without USPS

  • This article also has very helpful links to all of the states’ resources, regulations, and contacts

Several recent commentaries have shown scenarios impacted by this pandemic.  Thanks to Ben Gold for sharing these references.

CA Wong et al. Pediatrics, Mitigating the Impacts of the COVID-19 Pandemic Response on At-Risk Children

Here, we (1) highlight the health risks of the pandemic response measures to vulnerable pediatric subpopulations and (2) propose risk mitigation strategies that can be enacted by policy makers, health care providers and systems, and communities.

  • Children With Behavioral Health Needs
  • Children in Foster Care or at Risk for Maltreatment
  • Children With Medical Complexity

R Cholera et al. Pediatrics. Full link: Sheltering in Place in a Xenophobic Climate: COVID-19 and Children in Immigrant Families

One in 4 children (>18 million) in the United States lives in an immigrant family, in which the child or ≥1 parent was born outside the United States.1 Among children in immigrant families (CIF), >7 million live in “mixed-status” families, meaning ≥1 parent is not a US citizen.2 The COVID-19 pandemic amplifies existing inequities and introduces new ones as immigrant families navigate school closures, lack of health insurance and paid leave, and decisions to seek medical care or public services amid ongoing immigration enforcement. Additionally, immigrant families are more likely to live in multigenerational households,4 heightening the risk of COVID-19 for multiple family members…For CIF in US communities coping with persistent fears of immigration enforcement and family separation, economic devastation during a pandemic may threaten the stability of place. In this article, we apply a health equity framework5 to evaluate the impact of COVID-19 on CIF and highlight opportunities for advocacy and action for pediatricians, hospitals and health care systems, and policymakers to mitigate the unique risks faced by CIF

AM Evans et al. Pediatrics:  Pediatric Palliative Care in a Pandemic: Role Obligations, Moral Distress, and the Care You Can Give

Moral distress refers to the experience of being unable to take the action that one believes to be morally right or required.1 the inability to provide care because of resource constraints, involvement in care that one deems to be against a patient’s interests, and disputes about care planning with families and within teams…

We cannot have an obligation to save a life that cannot be saved: we can only be obliged to do what we can… It is only your role to act well within your scope of responsibility and to be the best clinician that you can be under the circumstances. Recognizing the limits of one’s powers can relieve a burden of guilt that is unconnected with one’s own choices and actions.

Famotidine may be helpful based on a retrospective study:

This long piece from Slate details the myriad public health mistakes in the U.S. approach to COVID-19: The Trump Pandemic

“Quietly” Testing Famotidine for COVID-19

Yesterday, I received two emails (first from Steven Liu) about an article in Science and today I’ve already seen this article is referenced in a CNN report:

New York Clinical Trial Quietly Tests Heartburn Remedy Against Coronavirus

Key points:

  • In China, a review of ~6000 patients suggested lower mortality in those taking famotidine (not statistically significant)
  • Famotidine may interfere with viral replication protease in the coronavirus based on computer modeling
  • A randomized trial with IV famotidine (large quantities are not available) is underway in New York using 9 times the dose used for heartburn.
  • The article notes that increased heart problems are common in those with reduced renal function
  • “We still don’t know if it will work or not”

My take: Famotidine may be a hot commodity –at least until studies are completed.  Based on experience with hydroxychloroquine, some of our patients may need to look for alternative acid blockers.

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How Effective are the Treatments for Functional Abdominal Pain?

According to a recent systematic review (Korterink JJ et al. J Pediatr 2015; 166: 424-31), “there is no evidence to support routine use of any pharmacologic therapy” for pediatric functional abdominal pain (FAP).  How many pediatric gastroenterologists want to discuss this conclusion with their patients?

How did the authors reach their conclusion?

Design: The authors screened 557 articles and ultimately identified only four articles with a total of 6 studies met inclusion criteria which included the following:

  • systemic review or randomized control trial
  • children 4-18 years
  • diagnosis of FAP established with well-defined criteria
  • intervention was compared to placebo or alternative treatment

Results: All of the studies were reviewed –each received an overall quality rating by the authors as “very low.” The particular treatments included amitriptyline, peppermint oil, famotidine, miralax, tegaserod, and cyprohepatadine.  The study with the most patients had only 90 patients and the longest treatment period was 4 weeks.

In the discussion, the authors make several key points:

  • there is a lack of adequately powered, high-quality, placebo-controlled drug trials in children with FAP
  • weak evidence was found in support of peppermint oil, cyproheptadine, and laxatives at reducing pain; amitriptyline and famotidine had weak evidence supporting some improvement in global symptoms or quality of life.
  • problems with the studies: small sample sizes, poorly reported side effects, lack of follow-up, risk of bias
  • “several nonpharmacologic therapies (e.g.. hypnotherapy and cognitive behavioral therapy) have shown their efficacy in treating children with” FAP…with success rates up to 85%.  Moreover, these therapies are not hampered by severe side effects.”

Bottomline: Our office-based psychologist may be more helpful for our patients than all the medications combined.

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