NDMA: What Is it and Why Should I Be Concerned?

Many lots of the drug Valsartan were recalled last year due to the contamination of n-nitrosodimethylamine (NDMA), a known animal carcinogen and a probable human carcinogen. More recently, a number of manufacturers recalled their Zantac and ranitidine products due to the belief that the drugs can naturally produce high levels of NDMA as a byproduct of the digestion process.  In May 2020, the Food and Drug Administration (FDA) announced it had found high levels NDMA in certain batches of the type-2 diabetes drug Metformin. Many individuals don’t know what NDMA is or how it can impact their health and lifestyle. Here we’ll explore what it is and why the recall was necessary.

Do I Have a Zantac Case?

Do I Have a Valsartan Case?

Do I Have a Metformin Case?

What Is NDMA?

NDMA is a semi-volatile organic chemical that can form naturally or unintentionally through industrial processes. Unintentional NDMA can form as a byproduct of the chlorination of wastewater and drinking water. This process led NDMA to be found in Valsartan tablets produced by four different facilities:  Zhejiang Huahai Pharmaceuticals in China, Hetero Labs Limited in India, Aurobindo Pharma in India, and Mylan Laboratories, Ltd. in India.

NDMA can also be formed through natural processes. Ranitidine, the active ingredient in Zantac, has a molecular structure that makes it susceptible to naturally creating NDMA once it is ingested. Specifically, the ranitidine compound contains the two elements that are required to form NDMA: nitrite (“N”) and dimethylamine (“DMA”). The presence of both nitrite and dimethylamine in ranitidine’s chemical structure renders it highly capable of producing NDMA under the right conditions.

A recent independent study conducted by Valisure Online Pharmacy sought to understand how capable ranitidine was of naturally producing NDMA. During the testing, Valisure simulated the conditions that ranitidine is exposed to in the human stomach to see how the ranitidine would react; namely, they mixed ranitidine with the gastric fluid and sodium nitrites that stimulate the digestion process. They found that when the ranitidine interacts with the gastric fluid and sodium nitrites found in the stomach, high amounts of NDMA are produced. In fact, when exposed to the simulated stomach conditions, the ranitidine produced approximately 304,500 nanograms (ng) of NDMA per tablet. This is an alarming amount of NDMA, considering the FDA-approved acceptable amount of NDMA intake is 96 ng per day.

Concerns about the molecular generation of NDMA associated with ranitidine have led to several recalls of ranitidine products.

In September 2019, there were voluntary recalls by Sandoz, Inc. and Apotex Corp. The Sandoz ranitidine recall involves 14 lots of prescription capsules, while the Apotex ranitidine recall involves all of its 75mg and 150mg over-the-counter capsules. Many of the Apotex capsules were labeled and sold by popular pharmacies Walgreens, Wal-Mart, and Rite-Aid.

In October 2019, numerous additional voluntary recalls have been announced. On October 23rd, it was announced the Dr. Reddy’s Laboratories Ltd and Sanofi would be recalling ranitidine products. The Dr. Reddy’s recall involves all prescription and over-the-counter capsules manufactured by the company, while Sanofi issued a recall of its over-the-counter ranitidine. On October 28th, it was announced that Perrigo Company, Novitium Pharma LLC, and Lannett Company, Inc. would be recalling ranitidine products as well due to the presence of NDMA. Perrigo Company is recalling all over-the- counter ranitidine tablets; Novitium Pharma is recalling all ranitidine hydrochloride capsules; and, the Lannett Company recall involves all lots of prescription ranitidine syrup.

While several recalls have already occurred, several other countries, including Canada, have taken further action by ordering complete recalls of all Zantac and ranitidine products.

In December 2019, the regulators for multiple global health organizations began testing samples of the type 2 diabetes drug metformin for NDMA contamination. As of December 5, 2019, there has been no metformin recall in the United States. The FDA said in a statement that it has not confirmed any NDMA contamination of metformin sold in the United States, but that any contamination detected beyond the acceptable daily intake limit will lead to recommended recalls. Singapore’s Health Sciences Authority announced on December 4 that is was recalling three metformin medications due NDMA contamination.

In March 2020, Valisure filed a citizen petition with the FDA after it found high levels of NDMA in certain batches of metformin. The citizen petition described Valisure’s testing protocols that improved the accuracy of its tesdting and requested the agency recall the contaminated metformin. On May 27, 2020, the FDA announced it had found high levels of NDMA in some versions of metformin. The agency said it would be in contact with the manufacturers of the contaminated batches to determine the appropriate next steps.

Metformin is manufactured as a generic by multiple global pharmaceutical companies. Popular brand name drugs sold in the United States that contain metformin include Fortamet, Glucophage, Glucophage XR, Glumetza, and Riomet.

What Are the Effects?

NDMA can contaminate drinking water and humans often get NDMA exposure from consuming food or drink that was contaminated with NDMA. Exposure to NDMA in Valsartan can cause prostate cancer, lower esophageal cancer, non-hodgkins lymphoma, leukemia, multiple myeloma, colon, stomach, intestinal, or pancreatic cancer. Even small amounts of exposure can lead to liver damage. Exposure to NDMA in ranitidine has been linked to a number of cancers including stomach cancer, cancer in the small and large intestines, colorectal cancer, esophageal cancer, kidney cancer, bladder cancer, liver cancer, prostate cancer, pancreatic cancer, leukemia, non-hodgkin’s lymphoma, and multiple myeloma.

Classified as a Carcinogen

The EPA classifies NDMA as a B2 carcinogen, meaning it is a probable human carcinogen. B2 carcinogens do not have enough human data but have a sufficient amount of animal data to conclude that it’s a potential carcinogen. Many animal studies were done to test NDMA, and they found that various species, including rats and mice, developed tumors in the liver, respiratory tract, and blood vessels after exposure to NDMA. The U.S. Department of Health and Human Services believes that NDMA is “reasonably anticipated to be a human carcinogen.”

Contact GoldenbergLaw

If you or a loved one contracted cancer after taking Valsartan, ranitidine, or metformin, contact the dangerous drug attorneys at GoldenbergLaw. We are committed to promoting safety through accountability.

Ten Steps to Follow After an Auto Accident

HELP! I Was In An Auto Accident, What Do I Do?

This is a question we hear quite often from new clients who recently experienced a car accident. Being involved in an automobile accident can be a very scary experience. In addition to facing personal injuries and property damage, there are often legal authorities, insurance companies, and at-fault drivers to deal with as well. Below are a few things to keep in mind if you are ever involved in an auto accident.Auto Accident Infographic

  1. Be sure to stop if you are involved in an accident. No matter how minor, do not drive away from the scene of an accident without stopping to address the matter appropriately first.
  2. Call the police. It is important to involve the authorities. The police will evaluate the accident, take statements, and write a police report that will later be available to you and others involved.
  3. Be honest and accurate. The police may have questions for you about what happened. It is important to make an accurate record by being honest and accurate to the best of your ability. If there is something you don’t know, indicate that rather than trying to guess.
  4. Be visible. If it is nighttime or visibility to other drivers is a concern, do all you can to make your location and presence known to passing traffic to avoid anyone else hitting your vehicle. Turn on your vehicle lights, place flares if you have them, or use a flashlight.
  5. Take photos. If you or someone you trust is able to do so, take photos of your vehicle and the other vehicles involved, specifically focusing on any vehicle damage and license plates. If it is possible given the circumstances, take photos of your injuries as well.
  6. Exchange auto insurance information with the other driver.
  7. Seek medical attention. If you feel you may need medical attention, get it, right away. Then follow your doctor’s orders.
  8. Call your auto insurance carrier to report this incident. They will likely have several questions for you about what happened. They may at some point ask to take a recorded statement. In many states, you are allowed to decline having your statement recorded.
  9. Keep documents related to the incident in one place. Create a file or an electronic record to keep track of documents related to the accident.
  10. Consider your legal rights. Consult an attorney as soon as possible if you are injured. An attorney could assist in helping you understand your rights.

If you or a loved one suffered an injury in a car accident, contact the auto accident attorneys at GoldenbergLaw for a free consultation. We will deliver the Gold standard advocacy you deserve.

How Do You Know If Your Baby Has Rickets?

What Is Rickets?

Rickets is a bone disorder that is caused by vitamin D deficiency. It is characterized by the softening and weakening of the bones. Vitamin D absorbs calcium and phosphate in the body, so the lack of vitamin D in a child’s body causes their body to have difficulty maintaining proper calcium and phosphorous levels in the bones.

Calcium and phosphorous are vital minerals for the body. Calcium and phosphorous combine with one another to form a mineral crystal that gives structure and strength to the bones. When a child has rickets, calcium and phosphorous are not properly absorbed into the bones, thus making them weak and soft.

Neocate and Rickets

A 2017 study at Yale revealed that Neocate formulas were linked to bone fractures, broken bones, hypophosphatemia (low phosphate levels), and rickets. When participants in the study were switched to an alternative formula, they saw immediate improvement in calcium and phosphate levels, ultimately improving their skeletal development.

The link between Neocate and rickets is not something the defendant, Nutricia, warns consumers and doctors about.  The only warning given to parents about bone disorders and fractures was a March 2016 statement that children using Neocate as a primary or sole source of nutrition “should be routinely monitored by clinicians.”

Warning Signs of Rickets

If you suspect your child has rickets, there are a few signs and symptoms to look out for. Typical symptoms of rickets, include:

  • Fussy behavior
  • Soft skull
  • Bone tenderness
  • Stunted growth and development
  • Bone pain
  • Bowed legs
  • Wide joints (wrists, elbows, and knees)

If you think your child may have rickets, take them to the doctor immediately. They will conduct a physical exam and run blood tests and x-rays. Rickets can be a serious disease if left untreated.

GoldenbergLaw Can Help

If you’re concerned about Neocate and rickets and the effect on your child, you are not alone. GoldenbergLaw is currently accepting cases in which a child has taken Neocate and experienced serious bone disorders, low phosphate levels, rickets, spontaneous fractures, and/or broken bones. Please fill out the form below or give us a call. We will help you understand your rights and choices.