In September, the Food and Drug Administration (FDA) issued new guidance for drug manufacturers on how to detect and prevent potential cancer-causing N-nitrosodimethylamine (NDMA) contamination in the medicine that the companies make. The new guidance from the FDA comes after several drugs were recalled due to the discovery of high levels of NDMA found in popular medications such as Zantac (ranitidine), valsartan, and metformin.
Latest NDMA Drug Recall
Metformin, widely used for diabetes, is the most recent drug to be recalled by the FDA because of high levels of NDMA, a type of nitrosamine, and “probable human carcinogen.” Metformin hydrochloride extended-release tablets are taken by those with type 2 diabetes to lower glucose levels.
The latest recall applies to metformin tablets between 500 mg and 750 mg sold under the brand name Time-Cap Labs, Inc., which is created by Marksans Pharma Limited. This new announcement by the FDA expands an earlier recall of the same product over the summer.
In the past year, multiple metformin products were found to contain NDMA, prompting seven other drugmakers to issue recalls for metformin hydrochloride extended-release tablets due to their carcinogenic contents.
NDMA and Cancer Risk
The FDA is currently investigating how NDMA can contaminate medications like metformin and ranitidine (commonly known as Zantac). Nitrosamines such as NDMA exist in small amounts in our environment, including our air, food, and water. However, they can potentially increase the risk of cancer with long-term exposure to higher numbers. The recently recalled medications exceed the FDA’s accepted daily intake guidelines.
The FDA identified conditions that increase the likelihood that nitrosamines can contaminate medications, including chemical reactions that occur when using recovered chemicals, contamination from vendor-sourced raw materials, inadequate purification, and lack of process control and optimization.
In September 2019, the FDA issued the first NDMA contamination-related recall involving the heartburn medication Zantac (ranitidine) after finding unacceptable levels of the contaminant. In their research, the FDA concluded that NDMA levels increase with storage time on store shelves or in medicine cabinets.
What the FDA does not know is when the contamination started. It is also unknown how many people who took drugs with high-levels of NDMA could be at increased risk of cancer.
Drug-Related Cancer Lawsuits
Right now, more than 500 federal Zantac lawsuits are pending in federal court here in Florida and experts anticipate that thousands of additional individual lawsuits may be filed in the future.
These coordinated proceedings (known as MDL No. 2924- In Re: Zantac [Ranitidine] Products Liability Litigation) are being litigated on behalf of patients that have been injured or died due to cancers of the bladder, kidney, pancreas, stomach, rectum, or colon following their chronic use of Zantac and/or ranitidine.
The team at Panter, Panter, & Sampedro is taking on cases from individuals who were harmed by NDMA contaminated drugs like Zantac. If you or a family member took Zantac and were later diagnosed with a form of cancer, you may be eligible to file a product liability lawsuit against the manufacturers of Zantac/Zantac.
Conversely, if you took Zantac but never developed cancer, you could still seek compensation by filing a class-action lawsuit against the drug’s manufacturers. A Zantac class-action lawsuit allows consumers who purchased prescription or generic Zantac to regain the money spent on the medication.
If you think you or a family member may be affected by Zantac or NDMA drugs, or are concerned about product liability, including defective and dangerous drugs, we are here to help and answer any questions you may have. Please give us a call for a free consultation at (305) 662-6178.
Llamas (2020, October 6). FDA Issues Guidance to Control NDMA in Zantac, Other Drugs. Retrieved from: https://drugwatch.com/news/2020/10/06/fda-issues-guidance-control-ndma-zantac-other-drugs/
CBS Miami (2020, October 13). Recalled: Widely-Used Diabetes Drug With High Levels Of Cancer-Causing Agent. Retrieved from: https://miami.cbslocal.com/2020/10/13/recalled-widely-used-diabetes-drug-with-high-levels-of-cancer-causing-agent