Earlier this year I wrote a blog post that discussed the recent revelation that Zantac might cause cancer. Scientists found a link between N-Nitrosodimethylamine (NDMA), a likely cancer-causing substance, and ranitidine, the key ingredient in Zantac.

A few things have changed since that blog post, such as the U.S. Food and Drug Administration (FDA) asking all manufacturers to immediately recall drugs containing ranitidine from the market.

Why Did the FDA Ask for a Recall?

The FDA based this decision on its findings that the levels of NDMA could increase over time when stored at higher than room temperatures. The FDA’s new testing found that “NDMA levels increase in ranitidine even under normal storage conditions.” The FDA also discovered that “the older a ranitidine product is, or the longer the length of time since it was manufactured, the greater the level of NDMA.”

There is debate on how the NDMA makes its way into medications such as Zantac. The FDA sometimes seems to take the approach that the NDMA is an impurity found in medications with ranitidine. However, the major theory is that as ranitidine breaks down in the human body, it creates very high levels of NDMA.

One study from 2016 supports this theory. Ten adults each took just 150mg of ranitidine (the recommended dose is 150mg, twice a day) with scientists analyzing their urine for 24 hours. They found that NDMA levels in the urine increased by a factor of 400.

Despite this massive increase, it’s still a conservative number. That’s because the human body will metabolize some of the NDMA before it can be removed through urine.

Regardless of how the NDMA finds its way into the human body, it’s clear that NDMA is something that people should avoid, especially for its increased cancer risks.

How Does NDMA Cause Cancer in Humans?

The World Health Organization explains that NDMA causes cancer when a particular enzyme converts NDMA into a methyldiazonium ion. This ion then leads to DNA damage, which can turn healthy cells into cancerous cells.

The U.S. Environmental Protection Agency (EPA) classifies NDMA as a “B2 (probable human) carcinogen.” This is based on studies that have found cancer in the liver, kidney and lungs of several different types of laboratory animals. Other studies have potentially linked NDMA to other cancers, such as pancreatic cancer, stomach cancer and bladder cancer.

Currently, there is the fear that Zantac and other medications containing ranitidine can lead to many types of cancers, including:

• Small intestine cancer
• Colorectal cancer
• Esophageal cancer
• Throat cancer
• Nasal cancer
• Thyroid cancer
• Liver cancer
• Brain cancer
• Colorectal cancer
• Kidney cancer
• Breast cancer
• Lung cancer
• Ovarian cancer
• Prostate cancer
• Testicular cancer
• Uterine cancer
• Multiple myeloma
• Non-Hodgkin lymphoma

It’s thought that this cancer risk is cumulative, which means the more someone takes ranitidine, the higher that person’s risk of developing cancer. The problem is that until last year, the widespread view by medical professionals was that ranitidine was an extremely safe drug. This means potentially millions of people were taking ranitidine non-stop for years and even decades.

Currently, more research is underway to better understand the links between NDMA and cancer, including exactly what types of cancers are the result of medications containing ranitidine.

If you have taken Zantac or any other drug with ranitidine for an extended period of time and have been diagnosed with any of the above cancers, it’s possible that your cancer was the result of you taking ranitidine.

As scientists complete their research and learn more, I’ll be sure to provide additional updates and information. In the meantime, feel free to call me at (919) 830-5602 if you have any questions, and if you took Zantac for an extended period and later developed cancer, call me to discuss your potential case against the pharmaceutical company Sanofi.

During the course of surgery, a doctor may need to find a way to connect sections of organs or close wounds. One way to do this is through the use of sutures, a special type of thread. Another way is with the use of surgical staples. The Ethicon surgical stapler is pictured at right.

Doctors commonly use staples over sutures during surgery because they offer several advantages, including:

• Lower risk of infection
• Speed of insertion
• Reduced adverse reaction to surrounding tissue

Two of the major manufacturers of surgical staplers in the United States include Covidien and Ethicon. This blog post will focus on Ethicon’s staplers, in particular those involved in its most recent recalls.

History of Problems with Surgical Staplers

Despite their advantages, widespread use and overall general safety, surgical staplers and staples do not have a perfect operational record. They have caused a variety of problems for patients, including:

• Tissue and organ tearing
• Postoperative connection leak
• Hemorrhaging
• Hemorrhagic shock
• Fistulas
• Sepsis
• Bleeding
• Death

These problems can be caused by surgical staplers can malfunctioning in several ways:

• Misfiring of the stapler
• The stapler failing to fire
• Improperly formed staples
• The staple line opening

Countdown to Recall

As a result of these problems, various stapler manufacturers have recalled their products and the U.S. Food and Drug Administration (FDA) has made several announcements regarding these issues. Here is a brief timeline of recent events:

March 8, 2019: The FDA issues a letter to health care providers describing the adverse events associated with surgical staplers and staples. The FDA mentions that from January 1, 2011 to March 31, 2018, the FDA received reports that included 366 deaths and more than 9,000 serious injuries.

April 11, 2019: Ethicon issues a recall for circular staplers because they do not fire properly and fail to correctly form staples when fired. The FDA classified this as a Class I recall, the most serious type, as they involve devices that could result in death. This recall applied to approximately 92,496 devices in the United States.

April 23, 2019: The FDA issues draft guidance. This is a proposal for new recommendations for surgical stapler and staple manufacturers requiring they include additional information on product labels.

April 24, 2019: The FDA issues a proposed order to change surgical staplers and staples for internal use from Class I medical devices to Class II medical devices. This change, if adopted, would allow the FDA to implement special controls to make the products safer.

May 30, 2019: The FDA holds an open meeting to discuss reclassifying internal surgical staplers and staples from Class I to Class II medical devices.

October 3, 2019: Ethicon issues a recall for Echelon Flex Endopath Staplers due to their failure to properly form staples. The FDA classified this as a Class I recall. More than 5,700 devices in the United States were subject to this recall.

Ethicon’s Most Recent Recall from October 3, 2019

Ethicon’s October 3, 2019 recall involved one product line, the Echelon Endopath staplers. Specifically, they involved the following products:

• Product code: EC60A – Echelon Flex 60 Endopath Stapler, Articulating Endoscopic Linear Cutter
• Product code: PCEE60A – Echelon Flex 60 Powered Plus Compact Articulating Endoscopic Linear Cutter
• Product code: PLEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 44cm Shaft Length
• Product code: PSEE60A – Echelon Flex 60 Powered Plus Articulating Endoscopic Linear Cutter 34cm Shaft Length

The lot numbers, as well as additional information concerning the identification of the specific products being recalled, can be found on the FDA’s Medical Device Recall website.

These staplers are being recalled because the stapler may have a component that is out-of-specification. This could create malformed staples, causing problems in patients. As of the date of the recall, Ethicon publicly acknowledged that the recalled products had caused seven serious injuries and one death.

Litigation Involving Ethicon Staplers

Some litigation has begun and it is ongoing. Concerning the products recalled by Ethicon on April 11, 2019, some individual lawsuits have begun, but are currently in the pre-trial stages of litigation.

As for the products recalled on October 3, 2019, there are few, if any, current lawsuits against Ethicon and Johnson & Johnson, Ethicon’s parent company. If there are any changes, I’ll be sure to let you know in an updated blog post.

Note: The information and images contained in this post were derived from FDA content and news sources.