FDA Metformin Recall – Weight Loss Surgery and Diabetes


FDA Recommends Voluntary Recall on Metformin Products

On May 28, 2020 the FDA issued a press release announcing they contacted five manufactures of the diabetic medication, Metformin and recommended they voluntarily recall the drug due to contamination.

The FDA will update their website as the companies respond (Link found HERE). As of the time of our blog only one company, Apotex Corp, has responded.

This is a good time to mention that many studies have shown that weight loss surgeries have a 45-95% remission rate on Type 2 diabetes. This depends on the type of surgery the patient has. Surgeries such as the Gastric Bypass have shown to have the most effective long term weight loss and a higher effect on the glucoregulatory gut peptides producing one of the highest rate of remission (Study HERE).

From our own observations, many of our patients have reported back to us an immediate effect on their blood sugars. Some have not taken diabetic medication from the day of their surgery onward.

For more information on the surgeries offered and our surgeons call 1-800-215-6497

The full press release is below:

FDA News Release

FDA Alerts Patients and Health Care Professionals to Nitrosamine Impurity Findings in Certain Metformin Extended-Release Products

Agency Continues Investigations of Nitrosamine Impurities in Drug Products

For Immediate Release: May 28, 2020

The U.S. Food and Drug Administration is announcing today that agency laboratory testing has revealed levels of the nitrosamine impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit in several lots of the extended-release (ER) formulation of metformin, a prescription drug used to control high blood sugar in patients with type 2 diabetes. The agency is in contact with five firms to recommend they voluntarily recall their products. Company recall notices will be posted on FDA’s website. There are additional manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled. The FDA is continuing to work closely with manufacturers to ensure appropriate testing. Assessments are underway to determine whether metformin ER recalls will result in shortages and the agency will work closely with manufacturers to prevent or reduce any impact of shortages.

“The FDA has strict standards for safety, effectiveness and quality, and the agency makes every effort based on science and data to help keep the U.S. drug supply safe. We understand that patients may have concerns about possible impurities in their medicines, and want to assure the public that we have been looking closely at this problem over many months in order to provide patients and health care professionals with clear and accurate answers,” said Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research. “Now that we have identified some metformin products that do not meet our standards, we’re taking action. As we have been doing since this impurity was first identified, we will communicate as new scientific information becomes available and will take further action, if appropriate.”

Patients should continue taking metformin tablets even after recalls occur, until they consult with their health care professional who can prescribe a replacement. Patients with type 2 diabetes could face dangerous health risks if they stop taking their prescribed metformin. The FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate; FDA testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin). The agency is working with manufacturers of the recalled tablets to identify the source of the NDMA impurity. At this time, the elevated levels of NDMA have been found in some finished-dose tablets of the ER formulation but have not been detected NDMA in samples of the metformin active pharmaceutical ingredient.

The agency is also asking all manufacturers of metformin containing ER products to evaluate the risk of excessive NDMA in their product and to test each batch before it is released into the U.S. market. If testing shows NDMA above the acceptable intake limit, the manufacturer should inform the agency and should not release the batch to the U.S. market.

In late 2019, the FDA announced it had become aware of NDMA in some metformin products in other countries. The agency immediately began testing to determine whether the metformin in the U.S. supply was at risk, as part of the ongoing investigation into nitrosamine impurities across medication types. By February 2020, the agency had identified very low levels of NDMA in some samples, but at that time, no FDA-tested sample of metformin exceeded the acceptable intake limit for NDMA. The FDA has maintained that it would continue with ongoing testing of metformin and other medications, and if any levels of NDMA or other impurities were identified, swift action would be taken.

Recently, the FDA became aware of reports of higher levels of NDMA in certain ER formulations of metformin via a citizen petition filed by a private laboratory. FDA laboratories tested the same metformin lots that the private laboratory found to contain NDMA above the acceptable intake limit. The agency confirmed unacceptable NDMA levels in some, but not all, of those lots. In other instances, our laboratory detected NDMA in lots that the private laboratory did not. The agency also found that the levels of NDMA, when present, were generally lower than reported by the private laboratory. Given FDA scientists’ deep experience quantifying these impurities in drugs, the agency is confident in the reliability of the FDA’s testing method and results and will continue to take action based on the latest scientific information. The results have also been consistent with the findings of other regulatory agencies’ laboratories around the world.

Additional Information

NDMA is a common contaminant found in water and foods including cured and grilled meats, dairy products and vegetables. 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. The FDA’s acceptable intake limit for NDMA in drug formulations is 96 nanograms per day. The FDA does not expect nitrosamines to cause harm when ingested at or below the acceptable intake limit levels (such low levels of nitrosamines are present in foods in low levels and ingested as part of usual diets) even over a long period of time (such as a 70-year lifespan). Nitrosamine impurities may increase the risk of cancer if people are exposed to them at above-acceptable levels over long periods of time, but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer. We are working to ensure medicines on the U.S. market do not exceed the acceptable intake limit.

The FDA has previously investigated the presence of nitrosamines in the U.S. drug supply. The investigation began with the blood pressure and heart failure medicines called angiotensin II receptor blockers (ARBs) and later expanded to include heartburn medicines, ranitidine and nizatidine, as well as diabetes medication, metformin and other medicines. In April 2020, the agency requested manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drug products from the market because of test results showing that NDMA in some ranitidine products increases over time and, when stored at higher than room temperatures, may result in consumer exposure to unacceptable levels of this impurity.

There are multiple reasons for the presence of NDMA in drugs. The FDA has previously found that the source of NDMA can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged. As food and drugs are processed in the body, nitrosamines, including NDMA, can be formed.

The FDA is taking a systematic approach to identify medicines with nitrosamines above the acceptable intake limit and remove them from the market. Improved technology enables the detection of even trace amounts of impurities in drug products and may be the reason why more products have been found to have low levels of NDMA. Today, better testing methods exist, and the FDA better understands the specific manufacturing steps that may increase the risk of nitrosamine formation. The FDA works closely with international drug regulatory agencies, who have also been testing drug products for NDMA and are collaborating to investigate the sources of these impurities.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Bypass > Sleeve For Type 2 Diabetes


weight loss surgery before after vertical sleeve bypass diabetes

Our BeLiteWeight team is no stranger to the scene of surgical weight loss options. After assisting more than ten thousand customers over the past fifteen years our patients stories have given us insight in to what options are better for certain people. Even if you or a loved one is not excessively overweight but is suffering from Type 2 Diabetes than bariatric surgery may help alleviate many symptoms and put the disease in to withdrawal. This has been the case for many of our patients!

However, certain procedures are more effective than others at combating Type 2 Diabetes. The two most common bariatric procedures are the Gastric Bypass and the Vertical Sleeve, but the Bypass has been shown to be exceptionally effective for those with Diabetes. This is likely to do with the the effects of the procedure on the stomaches absorption processes.

While BeLiteWeight has been vocal about this for many years, another study published at the end of last month concluded that the Gastric Bypass was the preferred option for Diabetes care. Nevertheless, both offer unique benefits and your entire medical history and current condition have to be fully considered before choosing.

For more information on Gastric Bypass and other weight loss surgical questions, please call BeLiteWeight today at 1-800-215-6497!

Guac & Cucumbers: Keto Style


The weather is getting warmer and that means avocado season is beginning to bloom! Instead of turning to tacos our team at BeLiteWeight would like to offer this tasty keto-friendly recipe for flavor bursting guacamole.

Just Four Ingredients!

2 Ripe Avocados

½ Cup of Chunky Salsa  (Without The Chip!)

¼ TSP Red Pepper Sauce

1 Thinly Sliced Cucumber

For more information on Gastric Sleeve and other weight loss surgical questions, please call BeLiteWeight today at 1-800-215-6497!

Obesity & Walking: The First Step


Too many people do not exercise because they believe that working out must equal long hours spent at the gym putting yourself through excruciating pain. However the benefits of just stepping outside your front door and leaving your home for a few minutes are staggering! Here are just a few reasons to walk more!

#1 – Greater Benefit for Obese

For those struggling with obesity these effects are even more amplified! At a power-walking speed of 4.5 miles per hour a 185 lb person would burn about 65 more calories per hour than a 155 lb person!

#2 – It’s Easy!

While walking may be troublesome for a select few, when compared to other forms of exercise such as running power walking is low-impact and minimally stressful on the body. Just start with a five minute walk and add two minutes every week!

#3 – More YOU time!

The time you spend walking is an opportunity for you to put on your headphones and jam out to your favorite tracks or listen to an audiobook.

#4 – The American Lifestyle

Americans take fewer steps than adults in Australia Switzerland and Japan which all have less issues with obesity and heart disease. Our lifestyle choices in America are not good for our bodies!

#5 – 50% Reduction of Select Diseases

High energy walking for 2-4 hours a week reduced the risk of diabetes, heart disease, and metabolic syndrome by 50 percent!

The 2008 CDC Physical Activity Guidelines recommends 30 minutes per day of moderate activity or 15 minutes per day of vigorous exercise. The BeLiteWeight team would like to challenge you to meet their standards!

For more information on Gastric Sleeve and other weight loss surgical questions, please call BeLiteWeight today at 1-800-215-6497!

Happy Birthday Dr. Rod!


With big smiles the BeLiteWeight Family celebrated Dr. Rodriguez’ birthday this past weekend! Having performed thousands of bariatric surgeries this exceptional man is highly honored within the international surgical weight loss industry and deeply loved by his own community as well. Just look at some of the comments from his patients! Thank you so much for everything you do Rod, & happy birthday again!

Here are some of the touching messages from his patients! He should be so proud!

For more information on Gastric Sleeve and other weight loss surgical questions, please call BeLiteWeight today at 1-800-215-6497!

You’ve Had Weight Loss Surgery, Now What?


At a high level, it's easy to understand what happens after weight loss surgery, right? You have a procedure, such as lap band surgery, and you lose weight. Simple, right?

Wrong.

Yes, most people who undergo weight loss surgery lose weight–but it's certainly not simple. It's a process that involves recovery, significant lifestyle changes, potential complications and then: weight loss.

Here's a closer look at what you can expect after weight loss surgery:

You’ve Had Weight Loss Surgery, Now What? Recovery
After a procedure such as lap band surgery, most people spend at least two days in the hospital. This gives doctors a chance to make sure the procedure went as planned and allows incisions to heal. Once you've gone home, you'll need to take it easy for three to five weeks. You'll be up and moving, but you'll want to avoid any strenuous activities.

Lifestyle
For your procedure to be successful, you'll have to change your diet significantly. Initially, you'll eat (drink) mostly liquids. Eventually, you'll be able to re-introduce more "normal" foods back into your diet–but your portions will shrink considerably. After a while, you'll want to get on a regular exercise routine. This will help maximize the benefits of the procedure–and keep you healthy.

On the other hand, you'll probably start to feel more energetic, and your risk for serious health problems such as diabetes, high blood pressure and even sleep apnea goes down significantly.

Potential complications
Of course there is risk that comes with undergoing a weight loss procedure such as lap band surgery. You'll want to make sure your incisions heal correctly and don't become infected. Constipation can occur, and so can the development of gallstones. You also may have excess skin, which can be dealt with through surgery. The good news is that relatively few people who have surgery (about 5 percent) have serious complications.

Weight loss
The ultimate goal, of course, is to lose weight. If you adjust your lifestyle and stay healthy, your chances of reaching your goal are good. Most people lose about 60 percent of their excess weight after surgery. And that's more good news!

The Reality of Obesity: Causes


Reality of Obesity | BeLiteWeight | Weight Loss Services The best way to control weight gain is to count the calories you eat everyday, especially when the scale starts showing excess weight gain. But more often than not, a few extra pounds are not taken as a warning and are often neglected, leading to a stage when you become overweight. In today’s world, where stress has become an integral part of life causing various related chronic diseases such as hypertension and diabetes, you cannot simply add to the risk by putting on more weight. Keeping a tab on the causes of obesity can help you control your weight gain.

Understanding the Causes of Obesity The causes of obesity in a person can differ and mostly depend on the lifestyle of an individual. Let’s crosscheck some of the causes that can lead to being overweight:

Energy Imbalance The most common cause is an imbalance of your energy levels. This means that the amount of calories you consume is less than the amount of calories used for carrying out your daily activities (including digestion). In such cases, the best way is to reduce the intake of calories and increase their digestion by following a certain exercise regime such as walking, running, yoga, aerobics, resistance training, etc. These small changes are enough to stop further weight gain and promote health in other facets of your everyday life.

Environment Your environment is another factor that leads to obesity. (Remember: we’re products of it!) Various things factor into our environment such as the habit of eating meals in large portions, lack of good parks or walking/running tracks, local culture, highly inactive and sedentary work and home life, lack of knowledge regarding healthy foods, and so on.

Genetics Having a family history of obesity is one of the main reasons people get and stay overweight. Researchers have shown that the tendency of your body to store fat is greatly influenced by your genes and there are many siblings who, even after growing up in a different environment with totally different eating habits, still have a common problem of obesity. Parents should start monitoring the weight of their kids at a very early age and inculcate in them the habit of eating healthy food in small portions.

Health Conditions Health conditions such as hypothyroidism, polycystic ovarian syndrome, and Cushing’s syndrome are known to cause obesity.

Other causes of overweight are medicines, pregnancy, and lack of sleep, emotional stress and growing age.