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December 2019 Archives

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.

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.

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