zantac Archives - Drug Law Journal

Lupin Pharmaceuticals Recalls Blood Pressure Tablets Due to Possible Carcinogen Contamination

Posted on October 25, 2021October 25, 2021

Lupin Pharmaceuticals issued a voluntarily recall of irbesartan and hydrochlorothiazide tablets. Tests on API batches of these medications revealed possible contamination with a cancer-causing impurity. Both medicines are used to treat high blood pressure and diabetic nephropathy in hypertensive patients with Type 2 diabetes.

Current Recall for Lupin Pharmaceuticals

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above specification limit for the impurity N-nitrosoirbesartan,” the Food and Drug Administration (FDA) reported. N-nitrosoirbesartan is a potential carcinogen for humans.

Between early October 2018 and late September 2021, Lupin Pharmaceuticals received four reports of illness from irbesartan. Patients taking the combination of irbesartan and hydrocholorothiazide tablets reported no illnesses.

Irebesartan was distributed nationwide in 75mg, 150mg, and 300mg formulas. They were sold through wholesalers, drug chains, mail order pharmacies, and supermarkets.

Previous Recalls Due to Potential Carcinogen Contamination

This recall is not Lupin’s first experience with possible carcinogen contamination. During the summer of 2020, the company, along with Sun Pharma, Bayshore Pharmaceuticals, and Granules Pharmaceuticals, pulled metformin, a generic diabetes medication, from the shelves due to batch testing results.

The recalls of metformin were in response to the FDA finding N-nitrosodimethylaine in “sartan”-based blood pressure drugs and heartburn medications, including Zantac. These findings triggered a global recall of all impacted medicines.

For more information about both the Lupin Pharmaceuticals recall and the Zantac recall, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Bladder Cancer Linked to Zantac Use in Recent Study

Posted on August 9, 2021August 9, 2021

Hundreds of plaintiffs have filed lawsuits arguing that, after years of using heartburn medication Zantac (ranitidine), they were diagnosed with bladder cancer. Now, a recent study supports their claims: The American Journal of Gastroenterology published research that indicates that users of Zantac products may face a higher chance of developing bladder cancer.

Link Between Ranitidine Use and Bladder Cancer

The new study looked at information from patients diagnosed with bladder cancer in Scotland between 1999 and 2011. Researchers matched the participants up with controls based on their age, gender, and general practice records. They ultimately gathered data on 3,260 cases of bladder cancer and 14,037 controls, showing that ranitidine users have a 22 percent higher risk of bladder cancer than non-users. The risk increased further if patients used the drug for over three years.

It’s important to note that these risks were not seen with proton pump inhibitors, another class of heartburn drugs. Examples include Nexium and Prilosec.

Although research linking Zantac and bladder cancer is in its early stages, there have been other studies that look at how ranitidine may increase levels of known carcinogen N-nitrosodimethylamine (NDMA) in the body. In a study from 2016, researchers collected urine samples from adult volunteers over a 24-hour period, both before and after taking 150mg of ranitidine. They then reviewed the samples for residual ranitidine, NDMA, and other nitrosamines. After ranitidine intake, urinary levels of NDMA increased 400-fold, while total N-nitrosamines increased 5-fold. Study authors noted that these rates “equaled or exceeded those observed in patients with schistosomiasis, a disease in which N-nitrosamines are implicated as the etiological agents for bladder cancer.”

FDA Recall of Ranitidine Products

In April 2020, the U.S. Food and Drug Administration (FDA) recalled all ranitidine products after studies revealed that storage time and high temperatures may increase the level of NDMA.

For more information about the Zantac recall and lawsuits, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Posted on July 15, 2021July 19, 2021

In a recent filing from lawyers representing over 70,000 former users of Zantac, Sanofi is accused of “widespread” email deletion related to its 2019 recall of the heartburn medication, which preceded the Food and Drug Administration’s (FDA) full ban in 2020. Lawyers claim that this tampering “resulted in the delay and/or postponement of many key Sanofi depositions.” They have asked for more time to prepare for these trials, which are set to begin next year.

A spokesperson for Sanofi revealed that the company “did not intentionally destroy any emails related to the Zantac litigation. Any suggestion to the contrary is false. Sanofi has provided hundreds of thousands of pages of relevant discovery to the plaintiffs, including internal emails, test results, safety assessments, and correspondence with regulatory authorities.”

Zantac Recall Timeline

In late 2019, Sanofi agreed to recall over-the-counter Zantac in the United States and Canada due to possible contamination with suspected carcinogen N-nitrosodimethylamine (NDMA). By April 2020, the FDA had removed the drug and all generic versions from shelves. In August 2020, Sanofi shared that it was the focus of a Department of Justice probe over potential violations of the False Claims Act in relation to the Zantac recalls.

Other drugmakers, including GlaxoSmithKline and Boehringer Ingelheim as well as multiple generic companies, are also accused in the Zantac lawsuits of failing to alert customers to the potential harm.

For more information about the Zantac recall and lawsuits, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Zantac Lawsuits & Updates

Zantac (Ranitidine) Commonly Asked Questions

Zantac Cancer Risk

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Posted on June 10, 2021July 8, 2021

In April 2020, the Food and Drug Administration (FDA) issued a recall of all prescription and over-the-counter (OTC) versions of ranitidine, more commonly known as Zantac, due to an increased cancer risk. Recently, the medication relaunched with a new name and ingredient: Zantac 360 (famotidine). The oral tablet is available in two strengths (10 mg and 20 mg) and without a prescription. It is only recommended for use by adults and children over the age of 12.

Famotidine and ranitidine are in the same class of medications. They are both H2 blockers and work equally well to combat heartburn, acid reflux, and other stomach ailments. After discovering that ranitidine contained a chemical called N-nitrosodimethylamine (NDMA), the FDA tested other H2 blockers for the carcinogen. Fortunately, famotidine has no traces of NDMA. Thus, these is no possible link to cancer, which means that Zantac 360 is a safer option for consumers.

Famotidine may look familiar: it’s the same active ingredient in Pepcid AC, another OTC heartburn medication, meaning Zantac 360 and Pepcid AC provide the same symptom relief without any benefits over the other. They both work within an hour and last for up to 12 hours.

This relaunch comes at a notable time. In addition to the hundreds of lawsuits that have already been filed against Zantac, a new study in The American Journal of Gastroenterology indicates that Zantac products may cause a 22 percent increase in the user’s risk of bladder cancer.

For more information about the Zantac recall and relaunch, contact us today.

Additional Reading:

Zantac Cancer Claims Invalid Under Federal Law

Zantac Lawsuits & Updates

Zantac (Ranitidine) Commonly Asked Questions

Zantac Cancer Risk

Zantac Cancer Claims Invalid Under Federal Law

Posted on March 22, 2021May 7, 2021

A federal judge recently threw out multiple claims by the plaintiffs in the Zantac cancer multi-district litigation (MDL) because the claims, which were filed under state laws, were barred by federal law.

MDL 2924, which now has more than 500 cases, was created in February 2020. These lawsuits focus on the belief that Zantac contains an undeclared carcinogen. Allegations made against the drug manufacturers include personal injury; negligence; violation of consumer protection laws; and design defects.

The recent ruling filed under state laws argued that the manufacturers of ranitidine (generic Zantac) created a flawed product and failed to notify consumers about it. The court ruled these claims invalid, effectively preventing manufacturers from addressing the defective design or the lack of consumer warning. Of course, the plaintiffs’ attorneys disagreed, arguing that the manufacturer could have changed the expiration date on the packaging without violating the law. Had the drug expired sooner, it would’ve been less harmful, as evidence shows that carcinogen levels in the drug increase over time.

The federal judge also accused the plaintiffs of making conflicting Zantac claims within the same case (which is not allowed based on court precedent). The plaintiffs argued that the drug was defective at the time of manufacture, which opposes the claim about expiration dates. If the drug was in fact harmful on the production date, then an earlier expiration date would not make it safe. These claims, both under state law, were dismissed.

While it is unclear how the case will proceed, the plaintiffs now have 30 days to file new, narrower claims. Some reports suggest that they will focus on possible legal labeling changes that should’ve been made by the manufacturers. Additionally, there are still pending claims under federal law that have not yet been addressed by the judge.

Additional Reading:

Keeping Up To Date On Potential Dangers of Medications

Zantac Lawsuits & Updates

Zantac (Ranitidine) Commonly Asked Questions

Zantac Cancer Risk

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Tag: zantac

Lupin Pharmaceuticals Recalls Blood Pressure Tablets Due to Possible Carcinogen Contamination

Current Recall for Lupin Pharmaceuticals

Previous Recalls Due to Potential Carcinogen Contamination

Additional Reading:

Bladder Cancer Linked to Zantac Use in Recent Study

Link Between Ranitidine Use and Bladder Cancer

FDA Recall of Ranitidine Products

Additional Reading:

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Zantac Recall Timeline

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Additional Reading:

Zantac Cancer Claims Invalid Under Federal Law

Additional Reading:

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