Zantac Recall Expands, New Options help PV patients calm Itching

MPN Patients have multiple Over The Counter options to relieve Itching!

by Jennifer Acker

For many PV patients the combination of Zantac (an H2 blocker) and Zyrtec (an H1 blocker) have been effective in providing relief from pruritus, a severe itching condition that is a common MPN symptom.  PV Reporter first uncovered this impressive treatment for itching back in 2016.  Here is a scientific explanation of why itching is prominent in up to 85% of us with an MPN.

But this past September, patients taking Zantac or its generic equivalent were alerted by the FDA that the over the counter drug may have higher than normal levels of cancer causing NDMA present. “Ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain NDMA, nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels.  NDMA is classified as a probable human carcinogen (a substance that may cause cancer) based on results from laboratory tests.  NDMA is a known environmental contaminant found in water and foods, including meats, dairy products, and vegetables.” Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research said in a statement this September.

In light of the findings, most major pharmacies including CVS, Walmart, Rite Aide and now Walgreens have already voluntarily pulled the drug from their shelves.

h1 and h2 inhibitors beat itching in MPNsAnd just recently, French drug maker Sanofi Pasteur announced it is also issuing a recall of the drug in the United States and Canada.  In a statement released October 18th Sanofi said, “As a precautionary measure, Sanofi will conduct a voluntary recall of Zantac OTC (over-the-counter) in the U.S. and Canada.  This recall is being taken due to possible contamination with a nitrosamine impurity called N-nitrosodimethylamine (NDMA).  The company is working with health authorities to determine the level and extent of the recall…Due to inconsistencies in preliminary test results of the active ingredient used in the U.S. and Canadian products, Sanofi has made the decision to conduct the voluntary recall in the U.S. and Canada as the investigation continues.”

The FDA is currently asking all companies that manufacture ranitidine to test their products using lower heat closer to normal body temperature.  High temperature testing levels may have affected the results of the NDMA found present, but it’s too early to tell if temperature regulation will impact the levels of NDMA.

So what does this mean for MPN patients who use a combination of H1 and H2 blocker to alleviate pruritus?  It’s still too early to know for sure; however, the FDA is advising patients switch to an alternative medication such as famotidine (Pepcid), cimetidine (Tagamet) or esomeprazole (Nexium) in lieu of ranitidine until further testing is conducted.

Patients of course should always consult with their doctors before beginning a new treatment.


Publishers Note by David Wallace

I am always looking ahead regarding new treatment options for MPNs, both OTC / natural methods and drugs in clinical trials.  About 18 months ago, I started using Xyzal (generic is levocetirizine) 5mg tablet once a day, instead of Zyrtec, as it was a more effective allergy medication for me.  It worked flawlessly in the combo as they are both antihistamines (H1 blockers).  Sanofi promotes Xyzal as a mirror image of Zyrtec, without the part of the drug that causes drowsiness (that was never a problem for me).

A few months later, I started using the generic version, levocetirizine, by prescription, a less expensive alternative….depending on your insurance.  This switch to a “generic script” was suggested by my pharmacist, as well as swapping out Zantac for famotidine (Pepcid).

Some key points:

  • Your pharmacist can be excellent resource for questions regarding your medications, optimal dosing schedule, as well as possible interactions between medications you are prescribed.  He or she should have a solid understanding of MPNs, symptoms and the medications being used to treat our funky blood cancers (obviously, this narrows the list quite a bit).
  • There is “Anecdotal Evidence” that taking any one of several H1 blockers (H1 antagonist, antihistamines) in combination with an H2 blocker (used to treat excess stomach acid) may provide the same relief from itching as the original Z and Z combo.  That is assuming the Z and Z combo worked for your to begin with.  It’s important to note the side effect profile on some these OTC medicines are not conducive to long term usage.  Talk to you doctor and/or pharmacist for the best advice.
  • It should be noted Zantac may be available by prescription, depending on supplies in your area.
  • Here is a running list of FDA updates and Press Announcements on NDMA in Zantac (ranitidine).

There are numerous strategies to beat Itching, here are a few.


 

About David Wallace

Founder of PV Reporter, a resource for Myeloproliferative Neoplasm (MPN) patients and caregivers. After being diagnosed with Polycythemia Vera (PV) in 2009, I utilized social media to connect with "informed patients" and develop a better understanding of emerging treatment options. My philosophy on patient care is straight forward - "educating the patient is essential, so the patient can guide their physician to meet his or her needs." PV Reporter is a comprehensive resource hub giving visitors vital tools to become "empowered patients."

 
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