Medication Safety Questioned as FDA Investigates More NDMA Claims

medication safety

With Valsartan and Zantac still making headlines due to possible carcinogenic contamination, it is no surprise that medication safety is being questioned by the masses.  But it is also being questioned by agencies like the U.S. Food and Drug Administration (FDA).  As the investigation into Zantac continues, the FDA is now investigating the possibility that another popular medication may contain NDMA.  The series of recent medication recalls is more than a little alarming.

New Medication Safety Concerns Related to NDMA

Early in December 2019, headlines related to N-Nitrosodimethylamine (NDMA) shifted from Zantac to Metformin.  According to the FDA, batches of Metformin in other countries have tested positive for NDMA, which has spurred the agency to initiate an investigation in the United States.  The Director of the FDA’s Center for Drug Evaluation and Research states,

“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.”

Outside the U.S., some Metformin has been recalled, but the FDA is not advising recalls in the U.S. at this time.  They state that they will update patients and healthcare providers if tests uncover high levels of NDMA, and will make appropriate recommendations at that time.

While the investigation is ongoing, there is no doubt that this latest NDMA risk is alarming consumers.  Metformin is the most commonly prescribed medication for Type 2 Diabetes.  Estimates suggest that, worldwide, doctors write more than 120 million prescriptions each year.

What is Metformin?

Metformin is an oral medication prescribed to treat patients with Type 2 Diabetes.  The drug helps control blood sugar levels either alone or in conjunction with insulin.  Metformin works by restoring the body’s insulin response to an adequate level.  This helps the body respond to naturally-produced insulin in a way that supports healthy blood sugar balance.  Metformin also helps decrease the amount of glucose that the liver produces and the stomach and intestines absorb.

Most people who take Metformin take it on a daily basis.  It is most successful when the patient also adopts healthy eating and exercise habits.  Generally speaking, the side effects of Metformin are mild, and may include:

  • Nausea
  • Vomiting
  • Weakness
  • Diarrhea
  • Metallic taste

Even though these side effects are unpleasant, Metformin is popular because it has less of an impact on the body and organs than other diabetes medications.  It is also much more affordable than brand name options like Glucophage, which makes it preferable to most patients.

What is NDMA?

NDMA (N-Nitrosodimethylamine) is a substance that occurs naturally in water, soil and certain foods.  The substance was originally discovered during the process of making rocket fuel.  It is a degraded compound of dimethylhydrazine and is a known contaminant of pesticides and other industrial processes.

Exposure to small amounts of NDMA, such as through food or water, is not dangerous to humans.  However, NDMA is a known probable human carcinogen.  That means that prolonged exposure or exposure to excessive levels of the substance could cause cancer in humans.

Because of the potential risk, the FDA has set a daily acceptable intake limit of 96 nanograms.  Recent studies of blood pressure medication and Zantac have revealed levels of NDMA far exceeding that daily intake limit.  Naturally, such tests cause alarm and concern among patients, healthcare providers and regulatory agencies.

Does NDMA Cause Cancer?

NDMA is a probable human carcinogen, meaning there is a potential that exposure to the substance could cause cancer.  According to the World Health Organization (WHO),

“There is conclusive evidence that NDMA is a potent carcinogen in experimental animals by several routes of exposure, including through ingestion of drinking-water.  NDMA has been classified by IARC as probably carcinogenic to humans.”

In toxicological tests, researchers found that the way that NDMA metabolizes means that humans are likely more sensitive to NDMA than animals.  In research, NDMA is linked to tumors and cancer involving the:

  • Liver
  • Lungs
  • Tongue
  • Esophagus
  • Pancreas
  • Kidneys
  • Bladder

Researchers still do not know the full extent of the risk of NDMA or what all types of cancer may be possible.  The FDA and other agencies continue to investigate the risk and several medications.

Have Questions About Medication Safety?

If you have questions about medication safety, your first step is contacting your healthcare provider.  Find out if you are at risk and if there is an alternative medication you can take.  Next, keep up with recalls and information from the FDA about NDMA risks.

If you have been diagnosed with cancer after taking Zantac, Valsartan or Metformin your next step will be determining if NDMA is a contributor to your diagnosis.  If so, you may have an actionable claim for compensation.

Find out more about your legal rights and taking legal action against defective or contaminated medications by calling Drug and Device Watch.  Our team of legal professionals is here to help you understand your rights and determine if you qualify to take legal action.  Call us toll free at 1-888-458-6825 to schedule a free legal consultation.  You can also contact us online through our confidential contact form.