Apotex Recalls Metformin for NDMA Contamination
Apotex Inc. is recalling 100-count bottles of 500 mg Metformin Hydrochloride Extended-Release Tablets, USP, NDC Number 60505-0260-1, after tests revealed the presence of NDMA, according to an FDA Recall Notice. Apotex discontinued the sale of metformin in the U.S. in Feb. 2019, but there still remains an undetermined quantity of the drug in circulation. This recall began on May 27, 2020.
Metformin Tainted with Cancer-Causing Toxin: FDA Investigation
Following the discovery of carcinogenic chemicals in metformin sold in other countries, the U.S. Food & Drug Administration (FDA) is investigating whether the diabetes medication may contain the same toxin that led to widespread recalls of valsartan and Zantac earlier this year.
What is NDMA?
In an FDA alert issued on Dec. 5, 2019, the agency said it was investigating whether metformin sold in the U.S. contains N-Nitrosodimethylamine (NDMA) or similar chemicals, known collectively as nitrosamines. NDMA was originally used to make rocket fuel, but this use was stopped after high levels of the compound were found in air, water, and soil samples collected near a rocket fuel manufacturing plant.
What Types of Cancer has NDMA Been Linked to?
NDMA has been linked to cancer in multiple human organs, including:
- Stomach cancer
- Colon cancer
- Rectal cancer
- Mouth cancer (oral cancer)
- Tongue cancer
- Esophageal cancer
- Gastrointestinal cancer
- Lung cancer
- Pancreas cancer
- Liver cancer
- Kidney cancer
- Bladder cancer
- And more
What is Metformin?
Metformin is an oral medication that helps control blood sugar levels in patients with type 2 diabetes, according to the Mayo Clinic. The drug works by reducing the amount of sugar the liver releases into the blood, and making the body respond better to insulin. Metformin is sold under the following brand names in the U.S.:
- Glucophage XR
Metformin Side Effects
In addition to having the potential to cause cancer, metformin has been linked to the following common side effects:
- Abdominal or stomach discomfort
- Cough or hoarseness
- Decreased appetite
- Fast or shallow breathing
- Fever or chills
- General feeling of discomfort
- Lower back or side pain
- Muscle pain or cramping
- Painful or difficult urination
Has Metformin Been Recalled?
In 2015, Actavis Laboratories recalled more than 13,000 bottles of metformin hydrochloride extended-release tablets due to failed dissolution specifications. However, no recall for metformin has been issued over the issue of potential NDMA contamination.
“While we are aware that some regulatory agencies outside the U.S. may be recalling some metformin drugs, there are no metformin recalls affecting the U.S. market at this time,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.”
Can I File a Class Action?
Our lawyers are currently only accepting potential individual lawsuits in the Metformin Litigation. We have decided against the filing of a class action in these cases in the best interest of our clients, who are likely to benefit more from individual suits. Contact us now to learn more about your legal rights if you think you may have a claim.
Do I Have a Metformin Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in metformin lawsuits. We are handling individual litigation nationwide and currently accepting new cancer cases in all 50 states.
If you or a loved one got cancer after taking metformin, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.