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An Ingredient Used to Make Rocket Fuel Was in My Medicine

It all started one night after eating spicy Indian food at a Christmas party. I woke up in the middle of the night in excruciating pain. I literally felt like someone had poured acid down my throat and my insides were all being burned. I would have gone straight to the emergency room the pain was so bad, but my husband, who is a pharmacist, immediately knew what was wrong.

You have acid reflux, he said, and gave me an over-the-counter medicine to lessen my acid production. I also spent the next few nights trying to sleep sitting up so the acid could not back up again. I have back and neck issues so this was not at all restful. I made an appointment to see my doctor and also immediately cut out all acidic, fatty and spicy foods from my diet. No coffee, no ketchup or sauce, no citrus, etc. As someone who lives with a rare disease, I am a good patient and am able to follow multiple diets for multiple conditions. I also tried all the home remedies like drinking aloe juice and eating ginger. I still needed medicine for my acid reflux/GERD.

I was first prescribed ranitidine (brand name Zantac) in December 2013. I took it every morning before breakfast and sometimes used it as a rescue pill if my nausea got too intense. My prescriptions have changed a few times but I have been on ranitidine for years. Even with the medicine and following a strict diet I still dealt with a lot of nausea, but I never had that horrible burning feeling again. Because of my nausea I never missed a dose and have not attempted to stop using this medicine. I was always glad for it. Glad that we live in a time with so many treatments for so many conditions. Ranitidine is also an older drug, used by millions with few side effects or interactions. It was considered safe enough to give to pregnant women and to babies. My doctor believed it was safe, My husband thought it was safe and so did I.

Fast forward to September 2019. I was on my computer and got an e-mail about Zantac possibly being recalled for n-Nitrosodimethylamine (NDMA). It’s an ingredient in rocket fuel that damages the liver and is a probable human carcinogen. In rats it causes tumors, cancers, internal bleeding and death. Pregnant rats given NDMA gave birth to dead rats or rats that died shortly after birth. I immediately called my husband and asked him if Zantac was the same drug as ranitidine. It is.

A small pharmacy named Valisure had discovered the problem with ranitidine because one of the pharmacists had a baby girl who was prescribed it and decided to test it. So many things I had believed about our healthcare system were about to be proven false over the next few weeks as I researched and reached out to everyone I can think of.

For one thing I always believed that the FDA — The Food and Drug Administration — tests our foods and medicines and makes sure we are all safe. Fifteen million patients were on prescription ranitidine a year, including pregnant women and babies, and many more bought it over the counter — all without the FDA testing it as rigorously as other medications. These drugs (and many others) are made over seas. Up to 80% of the ingredients in our medicines are now coming from overseas. The FDA is not able to regulate in the same way. Only one third of foreign manufacturing sites ever get inspected by the FDA. Even if things look great at the time of inspection there is little to stop a manufacturer from loosening quality controls or obtaining ingredients from a cheaper source later on. I found reports on the different ways overseas drug manufacturers “dupe” the FDA. Another news story I viewed said that documents were shredded before inspections and that some facilities refused inspection at all. And this is where our medication is coming from.

Many insurance companies will only pay for the cheapest version of a drug. Which is fine if they are all tested to be safe. Another millions of patients were on blood pressure medicines Valsartan, Losartan and Irbesartan which were recalled two years ago. All getting the toxic NDMA and other impurities in with their prescription for as long as four years! You would think if medicine is contaminated it would be caught quickly and recalled. Having patients on it for years without anyone catching it increases the odds of those patients developing cancer. Toxic exposures are cumulative. A sleeping FDA can prove to be deadly.

Our sweaters clearly state where they are made on the label. Our pill bottles do not. You must locate your manufacturer and see where the drugs and ingredients are coming from. Many patients have trouble following the directions on the bottle — yet alone tracking down where everything is coming from. And what if the insurance only will pay for the cheapest one? We need to make sure all medicines prescription, over the counter, brand or generic are safe. Everything coming in the U.S. needs to be tested.

There currently is discussion of lowering drug costs. We do not just need cheaper drugs. We need safer drugs. Unsafe drugs undermine modern medicine itself. People are living longer than ever because of modern medicine. Pharmacists, nurses and all forms of caretakers need to trust that they are helping patients and not hurting them when giving them medicine. Seventy percent of Americans take one or more prescribed drugs. Many more use popular over the counter medicines like Tylenol, cough syrup and allergy medicines. The medicine we take and we give to our children should be kept as safe as possible. This is a bipartisan issue I think we should all agree on.

I do not know what my outcome will be or for how long my ranitidine contained NDMA or even if all ranitidine breaks down to NDMA in your stomach as some tests may indicate. My genetic disease already makes me more likely to develop cancer and now I was consuming a dangerous substance for an unknown period of time. I have not gone to see my doctor yet to have my liver tested because with my primary immune deficiency disease, I try to avoid crowded waiting rooms where I might catch a new infection during peak cold and flu season. My nausea has dramatically improved since switching to a new prescription. The CDC and the FDA do not fully understand yet what NDMA does to the human body but with tens of million of people possibly exposed my guess is we will be learning. There are already nearly 600 cancer lawsuits for the blood pressure medicines that were recalled and groups are starting to study the effects of NDMA.

I started a Facebook group Make Medications Safer USA and I have reached out to lawmakers to try to fix some of the issues with medication that we find ourselves facing. I am also reaching out to health related organizations and fellow activists for support. I am doing all I can to keep unsafe medicines from happening to anyone else but there is little I can do on my own. Please join my fight. I want testing of all our medications being imported and I want clear labels that say what county manufactured a drug. Until that happens I want patients and doctors to choose whether brand or generic version of a drug is given — not the insurance companies.

harry
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