FDA Urged to Recall Metformin after Third Party Testing Shows NDMA in 16 Batches

recall, metformin, ndma, fda

Pharmaceutical companies are under more pressure than ever due to concerns about contamination and the presence of unsafe ingredients.  Readers will no doubt recall notable recent medication recalls like Zantac (ranitidine), Valsartan and Belviq.  Now, another popular drug, Metformin, is joining those ranks after third party tests found the probable human carcinogen NDMA (N-Nitrosodimethylamine) in 16 different batches of the drug.

Third Party Tests Find NDMA in Metformin

Valisure, an online pharmacy, conducted tests of various batches of Metformin, including batches from noted manufacturers Amneal Pharmaceuticals and Actavis Pharma Inc.  Valisure tested batches from 11 companies in total, and found NDMA in 16 batches.  Not only did Valisure find NDMA, but some batches had well over the acceptable daily intake limit.  One batch from Amneal had 16 times the acceptable daily intake limit.

Petition Urges FDA to Recall Metformin

Valisure filed a citizen’s petition to the U.S. Food and Drug Administration (FDA) urging them to recall Metformin and investigate their findings.  The FDA says they will respond directly to Valisure.

In December, the FDA began testing samples of Metformin sold in the United States, but no recalls were ever issued.  The FDA reports finding low levels of NDMA in Metformin, but those levels were within the acceptable daily intake limit of 96 nanograms per day.

Singapore and Canada both have active Metformin recalls, and European drug regulators are now testing for carcinogens.  The FDA says that they will continue to monitor the situation and will provide consumers and healthcare providers with updates.

What is NDMA?

NDMA, or N-Nitrosodimethylamine, is a probable human carcinogen.  It is a compound that occurs naturally in certain environments.  NDMA is produced during grilling or curing meat, and may be present in some dairy products and vegetables.  The level of NDMA in these products is generally very low, and well within the FDA’s acceptable daily intake limit.

The director of the FDA’s Center for Drug Evaluation and Research says,

“Everyone is exposed to some level of NDMA.  The FDA and the international scientific community do not expect it to cause harm when ingested at low levels.”

High levels of exposure or prolonged exposure can cause health problems, however.  Laboratory tests show that NDMA can cause serious liver problems and internal bleeding.  Tests have also shown an increased rate of certain cancers, including liver and lung cancer.

The World Health Organization (WHO) lists NDMA as a “potent carcinogen.” Research does not indicate a specific increase in the risk of cancer among people exposed to NDMA.  However, the WHO does warn that research is

“Supportive of the assumption that NDMA consumption is positively associated with either gastric or colorectal cancer.”

What is Metformin?

With type 2 diabetes, the body does not process insulin properly, and therefore, cannot stabilize blood sugar levels.  In healthy individuals, the pancreas makes insulin, which turns into glucose, which turns into energy for the body.  With type 2 diabetes, the body does not use glucose the way it should.  Instead, glucose builds up in the bloodstream causing high blood sugar.

Metformin is an oral medication used to help the body control blood sugar levels.  Metformin works by helping the body properly respond to insulin and process it correctly.  It also helps decrease the amount of sugar that the liver makes.  As a result, it also reduces the amount of sugar that the intestines and stomach absorb.

Metformin is sold under the brands:

  • Fortamet
  • Glucophage
  • Glucophage XR
  • Glumetza
  • Riomet

It is available in pill form, with the dosage and administration requirements varying depending on the patient’s needs.

Importance of Controlling Blood Sugar Levels

It is important to control blood sugar levels.  High blood sugar can cause a host of medical problems, some of which can cause permanent damage or be fatal.  High blood sugar can lead to:

  • Heart and blood vessel damage – People with uncontrolled type 2 diabetes are five times more likely to suffer a stroke or heart disease.
  • Kidney damage – High blood sugar affects the kidneys over time. High blood sugar can cause kidney failure over time.
  • Damage to the eyes – High blood sugar can cause damage to the blood vessels in the back of the eye. This is called retinopathy.  Without adequate treatment, retinopathy can cause permanent blindness.
  • Brain damage – Over time, high blood sugar can cause damage to the brain. It can also increase the risk of Alzheimer’s disease or dementia.
  • Skin problems – High blood sugar causes your blood to not circulate properly. This makes it harder for skin to heal properly if there is an injury.  Wounds that heal slowly are more susceptible to infection.
  • Sleep apnea – Many people with uncontrolled type 2 diabetes develop sleep apnea. This condition causes you to periodically stop breathing during sleep.
  • Nerves – Diabetic neuropathy is one of the most common side effects. Uncontrolled blood sugar levels affect the nerves and cause tingling and numbness (neuropathy).  This often occurs in the extremities, which can be dangerous if a wound develops.

Fortunately, many of these complications are avoidable.  Type 2 diabetes is a serious medical condition, but many people are able to control their symptoms and maintain a healthy lifestyle.  Most often, it is a combination of medication and lifestyle changes that is most successful.

Have Questions about a Medication Recall?

If you are one of the millions of people who take Metformin, Zantac, Valsartan or other drugs under investigation or recall, you likely have many questions.  Of course, the first place to start is your healthcare provider.  Your healthcare provider can answer many of your questions and make recommendations based on your health and benefits or risks of certain medications.

If you have questions about your legal rights, however, you should contact Drug and Device Watch.  Our legal professionals can offer you information about your legal rights and what options you may have if you are suffering due to a contaminated or recalled medication.  To find out more, contact us at 1-888-458-6825.  You can also request a free consultation online via our contact form.