Zantac Recall: FDA Recalls All Zantac & Ranitidine Products

On April 1, 2020, The Food and Drug Administration (FDA) requested the recall of all Zantac and ranitidine products from the U.S. market due to contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA).

Do I Have A Case?

Why Is The FDA Recalling All Zantac Products?

The FDA Zantac recall announcement acknowledges that NDMA impurities in the popular heartburn medications can increase to dangerous levels when the products are stored over time or exposed to higher temperatures. This determination echoes the findings reported to the FDA earlier this year by Emery Pharma, which found steady increases of NDMA production in Zantac and ranitidine products stored just above room temperature. Emery’s study also produced levels of NDMA exceeding the FDA’s daily acceptable intake limit of 96 nanograms in ranitidine products stored in temperatures as low as 158 degrees Fahrenheit for as little as five days.

Emery submitted these findings to the FDA in a Citizen Petition on January 2, 2020 and recommended the agency recall all Zantac and ranitidine products from the market. Additional testing has since found that older ranitidine products contained greater levels of NDMA, suggesting that NDMA levels in the drugs can increase over time.

Is This The First Zantac Recall?

No. The FDA has announced 16 different recalls of Zantac and ranitidine products since tests began discovering NDMA in the heartburn medications in September 2019. Until now, the agency had refrained from withdrawing all Zantac and ranitidine products from the market due to inconsistencies in NDMA levels found in previous tests. However, the FDA has now concluded that it can no longer guarantee the safety of the products due to unknowns about duration and conditions in which the drugs have been stored.

What Should I Do If I Am Currently Taking Zantac?

The FDA is recommending users of over-the-counter Zantac and ranitidine products to cease use immediately and safely dispose of any remaining medication. The agency advises patients taking prescription ranitidine products to speak with their healthcare provider to discuss alternative treatment options.

What Is NDMA and Why Is It Dangerous?

NDMA is considered a probable human carcinogen by multiple global health organizations. It was previously used to make rocket fuel, however, this was stopped after unusually high levels of the compound were found in the air, water, and soil samples collected near a rocket fuel manufacturing plant. NDMA is now only intentionally produced in the U.S. for research purposes.

Human exposure to unsafe levels of NDMA in Zantac and ranitidine products has been linked to the following cancers:

  • Bladder Cancer
  • Stomach Cancer
  • Intestinal Cancer
  • Colon/Colorectal Cancer
  • Liver Cancer
  • Kidney Cancer
  • Prostate Cancer
  • Esophageal Cancer
  • Pancreatic Cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Multiple Myeloma

How We Can Help

GoldenbergLaw is currently representing clients who have been diagnosed with cancer after taking Zantac or ranitidine products. The Zantac Recall Attorneys at GoldenbergLaw have over 30 years of experience delivering justice to victims of corporate negligence. If you are interested in learning more about a Zantac recall lawsuit, contact us today for a free consultation. Let us delivery the Gold standard advocacy you deserve.

FDA Recalls Belviq Due To Cancer Risks

On February 13, 2020, the Food and Drug Administration (FDA) requested a recall of the prescription weight loss medications Belviq (lorcaserin) and Belviq XR after a study associated long term use with certain cancers. Belviq’s manufacturer, the Japanese pharmaceutical company Eisai Inc., voluntarily recalled the drug in response to the FDA’s recommendation.

What Is Belviq?

Belviq was approved by the FDA in 2012 as a prescription weight management treatment. It is approved for use for adults who have a body mass index (BMI) of over 30 or adults who have a BMI of 27 or more and have additional health risks.

What Did The FDA Study Find?

Shortly after Belviq was approved, the FDA authorized a clinical study to analyze cardiovascular problems associated with the drug. The double blind, placebo-controlled study involved 12,000 patients over a five year period and found occurrences of certain types of cancer in 7.7 percent of patients taking Belviq. This compares to occurrences of cancer in just 7.1 percent of patients taking a placebo. The study found more incidences of cancer among patients taking Belviq over a longer period of time.

What Cancers Is Belviq Linked To?

Patients taking Belviq developed a range of cancers, but the most common cancers reported included:

  • Lung Cancer
  • Pancreatic Cancer
  • Colorectal Cancer

Why Did The FDA Recall Belviq?

The FDA initially issued a Drug Safety Communication in January 2020 warning the public of a possible link between Belviq and increased cancer risks. Less than a month later, the agency issued an updated Drug Safety Communication recommending that Eisai Inc. recall Belviq from the U.S. market. The agency concluded that “the risks of lorcaserin outweigh its benefits” after its review of the clinical study.

How GoldenbergLaw Can Help

GoldenbergLaw is currently handling cases where an individual has taken Belviq and developed lung cancer, pancreatic cancer, or colorectal cancer. Contact us today for a free Belviq cancer lawsuit evaluation. Our Minnesota Cancer Attorneys have been litigating complex cancer cases for over three decades, let us deliver the Gold standard advocacy you deserve.

Is Metformin Safe? Global Health Agencies Investigating Link to NDMA

Over the past year, world regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have uncovered, investigated, and recalled medications due to nitrosamine impurities such as NDMA. In 2018, many of the blood pressure ‘sartan’ medications (angiotensin II receptor blockers known as ARBs), including Valsartan and Losartan, were recalled due to NDMA contamination. In 2019 and 2020, various companies have issued voluntary recalls of popular heartburn medication Zantac and other ranitidine products after uncovering NDMA contamination.

In December 2019, the global investigations of NDMA impurities extended to the type-2 diabetes drug Metformin after the public health agency of Singapore recalled three out of the 46 locally marketed Metformin medications due to the presence of NDMA.

Singapore Metformin Recalls

Singapore’s Health Sciences Authority (HSA) tested all 46 locally distributed Metformin medicines and three were found to have trace amounts of NDMA which were “above the internationally accepted level.”

As a result, on December 4, 2019 the HSA recalled the three medicines as a “precautionary measure” but also announced that the other 43 Metformin medications were not contaminated.

Which Metformin Medications were Recalled in Singapore?

  • One batch of Glucient XR Tablet 500mg—supplied by Glorious Dexa Singapore
  • All batches of Meijumet Prolonged Release Tablet in 750mg and 1000mg –supplied by Pharmazen Medical

Singapore’s HSA claims that the risk to patients who have been taking the affected medications is “very low” because the potential risks of nitrosamine contamination is associated with long-term use of the affected drugs, and the recalled medicines have only been sold in Singapore since 2018.

Have Any Other Government Health Agencies Recalled Metformin?type-2-diabetes-pills

Currently, only Singapore’s HSA has issued recalls for Metformin medications. However, as a result of the recalls, worldwide regulatory agencies such as the U.S. FDA, Health Canada, European Medicines Agency (EMA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) have opened investigations into possible NDMA contamination in their Metformin medications.

In statements from the FDA, EMA, Health Canada, and MHRA, the agencies claim that there is no evidence that any Metformin medications distributed in their respective territories are affected and have advised patients to continue taking their medications.

U.S. FDA’s Metformin Investigation

The FDA reacted to Singapore’s Metformin recalls by announcing an investigation into potential NDMA impurities in Metformin available in the United States. Currently, no Metformin recalls have been issued by the FDA and no NDMA contamination has been found in lots sold in the United States.

Pertaining to the affected samples outside of the United States, the FDA claims that “based on the information we have available, the levels of NDMA seen outside the U.S. are within the range that is naturally occurring in some foods and in water.”

The investigation will determine whether there is NDMA in Metformin, and if so whether that amount is above the United States’ acceptable daily intake limit of 96 nanograms. The FDA “will recommend recalls as appropriate if high levels of NDMA are found,” according to a statement from Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Dr. Woodcock recommends that U.S. patients should continue taking Metformin while the investigation continues to keep their diabetes under control because “there are no alternative medications that treat this condition in the same way.”

European Medicine Agency’s Metformin Investigation

The EMA—the drug advising department for the European Union—has partnered with companies manufacturing and distributing Metformin within the EU to test the medication for NDMA. The results have thus far found no data indicating that EU Metformin medicines have been affected and recommends that patients in the EU should continue taking Metformin as prescribed.

The EMA is aware of trace amounts of NDMA found in a small number of Metformin medications outside of the EU; however, the organization claims that the levels of NDMA found in affected non-EU Metformin medicines are very low and appear to be within or even below the range people can be exposed to from other sources including water and certain foods.

Health Canada’s Metformin Investigation

Health Canada has asked drug manufacturers and distributors of Metformin to “test their own Metformin products” and will be “collecting samples from those companies to conducts its own testing.”

After the investigation, Health Canada announced that it is not aware of any Metformin products available in Canada that contain NDMA above the acceptable limits; however, it is working closely with international regulatory agencies to continually assess the concerns.

What is Metformin?

Metformin is a prescription medication available in both generic and brand name forms that helps those suffering from type 2 Diabetes by lowering blood sugar levels. The immediate-release form of the medication is Glucophage and the extended-release forms of the medication are Glucophage XR, Fortamet, and Glumetza.

How Does It Work?

In patients suffering from type 2 Diabetes, insulin (the hormone that helps the body remove extra sugar from the blood) naturally produced by the pancreas is unable to get sugar into the body’s cells where it can be properly converted into energy. Metformin, which belongs to a class of drugs known as biguanides, works by reducing the amount of glucose (sugar) made by the liver, decreasing the amount of glucose absorbed by the body, and increasing the impact of naturally produced insulin within the body.

What is NDMA Contamination?

N-nitrosodimethylamine (NDMA) is classified as a probable human carcinogen—meaning that the substance can cause cancer and belongs to class of impurities known as nitrosamines.

NDMA is commonly found in drinking water, some processed foods (pickled vegetables, salted fish, and processed meat products such as bacon and sausages), and as a result of air pollution.

NDMA was once used to make rocket fuel. However, after high levels of NDMA were uncovered in the air, soil, and water samples near manufacturing plants, NDMA use was discontinued. However, NDMA contamination occurs today through unintentional chemical reactions at industrial sites or in the manufacturing process of drugs.

Low levels of NDMA exposure are not dangerous. However, if more than 96 nanograms of NDMA are ingested daily, there is an increased risk of cancer.

Overexposure to NDMA can lead to:

  • Jaundice
  • Fever
  • Vomiting
  • Abdominal cramps
  • Dizziness

Prolonged Exposure to NDMA Contamination can lead to tumors and cancer of the:

  • Liver
  • Stomach
  • Colon & Intestines
  • Esophagus
  • Kidneys
  • Pancreas
  • Bladder

How GoldenbergLaw Can Help You

If you or a loved one contracted cancer after taking a drug recalled due to NDMA contamination, contact the dangerous drug attorneys at GoldenbergLaw. We are committed to promoting safety through accountability and providing you with the gold standard of advocacy.