Step 1. Read this letter.
Step 2. If you live in the US, find the contact information for the three members of Congress (two U.S. senators and one U.S. representative) that represent you.
Step 3. Copy, paste, and edit this letter. Here’s a Google doc version of the letter. Send it to each of your three members of Congress via U.S. postal mail, email, or webform.
Step 4. Let me know in the comments or on social media who you sent your letters to!
Dear [member of Congress],
I am writing regarding the FDA’s request to remove all ranitidine products (including Zantac) from the market in April 2020. While ranitidine is commonly known as a medication that reduces heartburn discomfort, it is a critical daily antihistamine for people, like me, who have mast cell disease.
Many mast cell disease patients depend on ranitidine to eat, move, and sleep. Mast cell disease causes excessive release of histamine. Ranitidine is an antihistamine that blocks histamine H2 receptors, which are located throughout the body, including the brain and cardiovascular system. Without an effective H2 blocker, mast cell patients can experience severe allergic reactions including nausea, vomiting, hives, migraine, sleep disruptions, asthma, throat swelling, pulmonary edema, and life-threatening complications.
For many mast cell patients, the known benefits of taking ranitidine outweigh the potential health risks cited by the FDA. In its April 1, 2020 statement, the FDA announced, “NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine. Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water.” If ranitidine’s potential risk is less than common foods, such as bacon and cured cheese, doctors should be allowed to decide whether or not to prescribe ranitidine. There are no known cases of cancer caused by ranitidine.
The FDA seems completely unaware of the impact its actions on mast cell disease patients. While other H2 blockers such as famotidine (Pepcid) and cimetidine (Tagamet) may be effective alternatives for people without mast cell disease, this is uncommon among mast cell disease patients. As a result, mast cell patients are turning to medications, such as steroids and biologics, which have proven health risks.
The timing of FDA’s actions is alarming. The loss of ranitidine puts unnecessary strain on an already overwhelmed health care system. Furthermore, the FDA’s actions have contributed to drug shortages of famotidine. At the same time, researchers are stockpiling famotidine for COVID-19 clinical trials. Many mast cell patients are struggling to access any (prescription, compounded, or OTC) H2 blocker medication.
Please urge the FDA to reconsider its actions and allow ranitidine to immediately return the prescription market.
Sincerely,
[your first and last name]
[your street address]
[city, state zip code]