Amidst the nationwide pandemic brought about by COVID-19, attorneys in Boca Raton are still hard at work fighting for those in need of proper representation.

The most recent focus of pharmaceutical malpractice attorneys is the Zantac drug lawsuit, which has put a large population of people at risk of cancer.

Read below to learn more.

Zantac Drug Lawsuit

As of April 1st, 2020, The U.S. Food and Drug Administration (FDA) has recalled all Zantac and generic Zantac OTC ranitidine drugs. This highly popular medication used to treat heartburn, acid reflux as well as numerous other gastrointestinal, throat, and stomach issues have been taken off the shelves amidst the Zantac drug lawsuit.

The FDA has found that storing this medication at a temperature higher than room temperature can result in an increase of the active ingredient N-Nitrosodimethylamine (NDMA). With this increase in NDMA levels, exposure to the average consumer is at a carcinogenic level.

When reviewing the effects of NDMA the World Health Organization (WHO), the Environmental Protection Agency (EPA), and the FDA have classified the substance as cancer-causing.

When pharmaceutical malpractice attorneys began to take a closer look at the situation, it was discovered that studies dating back to the 1980s have also come to the same conclusion.

However, Sanofi and Boehringer Ingelheim, the company responsible for the manufacturing of Zantac, were well aware of these side effects and made the decision to withhold this information from the general public. This irresponsibility puts many at risk as Zantac is the first drug to generate $1 billion in sales.

Under U.S. District Judge Robin Rosenberg, serving the Southern District of Florida, cases have been consolidated due to the potential size of the litigation. As of February 2020, there have been 140 cases.

Pharmaceutical malpractice attorneys are now reaching out to those who may have been impacted by this negligence. If you have taken this medication and now have developed cancer, you may be eligible for compensation.

Origin

In September of 2019, a Connecticut based online pharmacy revealed to the FDA that they had found NDMA in some samples of Zantac and the generic affiliate, ranitidine.

These findings then led major retailers, such as CVS and Walmart, to remove the product from their shelves.

This is not the first appearance of high levels of NDMA in medications. July of 2018, Valsartan, a medication used to treat high blood pressure and heart failure was also found to have traces of the contaminant which led to a nationwide recall.

Pharmaceutical malpractice attorneys have expressed how the Zantac drug lawsuit differs from the Valsartan lawsuit because the active ingredient in Zantac, ranitidine, can actually form in the body in addition to pre-contamination.

About NDMA

N-Nitrosodimethylamine (NDMA) is found not only in Zanac but in household foods as well as other medications. Angiotensin II Receptor Blockers are used to treat blood pressure and heart conditions and have been found to contain this carcinogenic ingredient.

NDMA is most closely linked with stomach cancer as well as bladder cancer. Although ingestion is never recommended, the body can tolerate it in small doses. The FDA has concluded that human consumption should not be more than 96 nanograms — one billionth of a gram.

When the Connecticut based online pharmacy tested individual tablets, they found 2,511,469 ng of NDMA in Zantac OTC and 3,267,968 ng of NDMA in Zantac Cool Mint from CVS. This is 31,250x the approved ingestion amount! The abnormally high levels of NDMA found in medications is what has led to the recall.

When the substance was tested on rats, studies found that fibrosis of the liver occurred with high exposure as well as liver tumors in chronic low doses.

It can also form when cooking foods that contain sodium nitrate as a preservative. Of the foods that contain this chemical, the most common are cured meats, fish, as well as selective cheeses, alcoholic beverages, tobacco, fruits, and vegetables. Although levels in these products have been deemed unlikely to bioaccumulate, become concentrated inside of the body, It is more important than ever that you know what is in the food you are eating.

NDMA in the News

One of the first reports of NDMA occurred after it was found as a contaminant in California groundwater during the years of 1998 and 1999. It was said to have come from a nearby manufacturer of rocket fuel. One of the components of rocket fuel requires NDMA in order to synthesize. This process has since ceased after high levels of the chemical were found in air, water, and soil samples.

Also, water treatment that uses the process of chlorination or chloramination of organic nitrogen-containing wastewater has also been linked to the creation of unsafe levels of NDMA.

Amneal Pharmaceutical has voluntarily recalled their nizatidine oral solution after learning of the possibility of unacceptably high levels of NDMA in their product. The FDA has advised companies to recall their nizatidine if it shows levels of NDMA above the acceptable daily intake limit.

As of recently, Lupin Ltd has conducted a voluntary recall of their medication, Metformin Hydrochloride extended-release, which is used to combat diabetes. Some of the samples of the drug that were tested contained higher levels than the acceptable daily intake limit. This recall was done out of caution in light of the Zantac recall.

Granules Pharmaceuticals, Inc., another manufacturer of Metformin Hydrochloride, also recalled their product. This was after 12 batches of the substance were tested and 1 of them was found to contain NDMA levels higher than the FDA approved limit. They have yet to receive any reports of adverse effects pertaining to these findings.

Getting Help

If you have taken any of these medications and have experienced negative side effects due to NDMA, we urge you to reach out to pharmaceutical malpractice attorneys in your area.

Specifically pertaining to the Zantac drug lawsuit, this is a high profile case that has occurred due to the negligence of the pharmaceutical company. Compensation is owed to those who have been affected.

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