FDA FINDS NDMA CONTAMINATION IN YET ANOTHER DRUG

 

MTN previously opined that our research indicates that the current Zantac litigation is just the tip of a much larger iceberg.
It appears our prior opinion may become reality, sooner rather than later.

Nationwide Recalls of Nizatidine, Heart Medicine and Blood Sugar Drugs Due to NDMA Impurity.

On April 15th, 2020 Amneal Pharmaceuticals of Bridgewater, New Jersey announced that it is voluntarily recalling three lots of Nizatidine Oral Solution, a heartburn medicine packaged in 480 ml bottles. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly-owned subsidiary of Amneal Pharmaceuticals.

The reason is that Nizatidine contains the impurity NDMA (N-nitrosodimethylamine), which is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

About 15 million Americans take Proton Pump Inhibitors (PPIs) like Nizatidine each year to treat common conditions such as gastroesophageal reflux disease (GERD).

There is no Nizitadine multi-district litigation docket at this time however, MTN expects numerous cases involving all H2 Blocker Acid Reducers to be filed this year, without regard to the existence of a consolidated litigation (MDL).

In addition to evidence that NDMA is carcinogenic, the literature also supports the conclusion that NDMA causes still births, certain birth defects as well as organ failure in adults.

First FDA Removal Request

Back on April 1, 2020, the FDA requested that all makers of all ranitidine drugs (Zantac and generics) remove their products from the market. This was the first time the FDA requested market withdrawal of all ranitidine products.

Ranitidine works by reducing the amount of acid your stomach produces. It is used to treat and prevent ulcers in the stomach and intestines. It also treats GERD and other conditions in which acid backs up from the stomach into the esophagus, causing heartburn.

“The FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity,” the agency says.

As of April 15, 229 Ranitidine lawsuits are being overseen by US District Judge Robin L. Rosenberg in MDL 2924, IN RE: Zantac (Ranitidine) Products Liability Litigation.

The FDA has also ordered recalls of entirely different drugs where NDMA impurities were found:

  • Valsartan, Losartan, and Irbesartan, which are Angiotensin II Receptor Blockers (ARBs), which are used to treat high blood pressure and heart failure.
  • Metformin, which is a prescription drug used to control high blood sugar in patients with type 2 diabetes.

Nizatidine, like Ranitidine Hydrochloride (Zantac), is a histamine H2 receptor antagonist that inhibits stomach acid production. Nizatidine was patented in 1980 and approved for medical use in 1988. Eli Lilly developed it, and brand names include Tazac and Axid.

Amneal Pharmaceuticals denied it has received any reports of adverse events that are confirmed to be directly related to the recall. Nizatidine Oral Solution is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).

Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can send an email to Inmar Intelligence DrugSafety@amneal.com for further information.

Heartburn Medications Lawsuits in MDL 2789

The first heartburn medication lawsuit was filed in the Western District of Tennessee against AstraZeneca’s Nexium in May 2016. The PPI kidney failure lawsuit alleged that the defendants knew or should have known about the significantly increased risk for kidney injuries and failed to adequately warn consumers.

Multidistrict Litigation (MDL 2789) was finally approved on August 2, 2017, to streamline proceedings. By July 2018, 4,618 kidney failure lawsuits were still pending before U.S. District Judge Claire C. Cecchi in New Jersey.

Today there are 13,432 PPI lawsuits filed in MDL 2789, IN RE: Proton-Pump Inhibitor Products Liability Litigation (No. II)

 

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