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Pharmaceutical Litigation Archives

The new year brings in more heartburn drug recalls

Toward the end of 2019, consumers in Ohio and elsewhere learned that a popular medication some have taken for decades contained a human carcinogen that could give them a variety of cancers. Since Sept. 2019, numerous pharmaceutical companies have voluntarily issued recalls for products containing ranitidine, a popular heartburn reliever. Some people may have hoped that the new year would bring better news, but instead, the Food and Drug Administration only continues to widen heartburn drug recalls.

Understanding why drug recalls happen

The controversy surrounding Zantac and other medications containing ranitidine has brought up numerous questions from many consumers across the country and here in Ohio. Drug recalls happen often for a variety of reasons, but people may not have paid much attention to why this happens until now. The information below may provide some insight into the process.

FDA approval doesn't guarantee a medication is safe

Over the last year or so, some highly popular medications for acid reflux, high blood pressure and diabetes have been recalled. Potential safety concerns have also prompted investigations by the Food and Drug Administration. The recent recalls by numerous manufacturers of medications containing ranitidine, such as Zantac, has many patients here in Ohio and elsewhere wondering whether they can take legal action against manufacturers even though the medications received FDA approval at one time.

Can the Zantac recall save others from harm?

Drugs are taken off the market all the time, but sometimes, the medication is so popular that it causes authorities to take a look elsewhere. Technically, the recent surge in testing of medications for contaminants started with popular blood pressure medications, but things really took off with the recall of Zantac across the country, including here in Ohio. Perhaps, the fact that an immensely popular and widely used over-the-counter medication could contain the same human carcinogen prompted closer scrutiny.

How do ranitidine medications work?

The recall of Zantac and its generic forms has raised serious questions for people across the country regarding how a dangerous human carcinogen like NDMA could end up in them. But, that is not the only question being asked. The Food and Drug Administration also wants to know how the body converts the ranitidine medications into this human carcinogen. Could the answer lie in how the medications work?

Zantac wasn't the first ranitidine drug to be recalled

When the Food and Drug Administration and the maker of Zantac announced its recall of the popular over-the-counter acid reducing medication, it was everywhere in the media around the country and here in Ohio. However, Zantac was not the first medication recalled. Back on Sept. 23, the Food and Drug Administration announced the recall of Ranitidine Hydrochloride Capsules made by Sandoz Inc. That recall occurred due to the presence of elevated levels of N-Nitrosodimethylamine, the very chemical involved in the recent ranitidine drug recalls.

Food and Drug Administration expands NDMA testing requirements

As the ranitidine recall situation continues to unfold across the country and here in Ohio, manufacturers, distributors and sellers are scrambling to get products off the shelves. In the meantime, the scientific community is attempting to figure out just how N-nitrosodimethylamine, popularly known as NDMA, ended up in this medication. As part of that initiative, the Food and Drug Administration has expanded its testing requirements of products containing ranitidine and now nizatidine as well. 

What NDMA is and what overexposure looks like

What began as a recall of heart failure and blood pressure medications continues to expand to other popular medications taken for heartburn by numerous people across the country. To this point, most Ohio residents have heard about the recall of Zantac and its generic equivalents due to the same impurity that could cause cancer. The problem is that most people do not understand what NDMA is and how to tell if they suffered too much exposure to it.

Handling holiday heartburn after the ranitidine recall

During the holidays, most people eat foods they do not ordinarily eat the rest of the year. For many of them, including people here in Ohio, that means heartburn. If you used to use Zantac to handle your holiday heartburn, you may need to find another way to find relief in the aftermath of the ranitidine recall.

Did the FDA miss the potential harm from ranitidine?

Numerous countries decided to simply discontinue the manufacturing, distribution and selling of Zantac and its generic equivalents off the market. Here in the United States, the Food and Drug Administration decided to continue testing and determining how nitrosodimethylamine, popularly known as NDMA, forms in the medication. In the meantime, consumers here in Ohio and elsewhere may be wondering whether they will suffer harm from ranitidine.

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