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FDA finds contamination in several brands of diabetes drug

WASHINGTON — U.S. health regulators are telling five drugmakers to recall their versions of a widely used diabetes medication after laboratory tests found elevated levels of a contaminant linked to cancer.

The Food and Drug Administration said late Thursday that several batches of the drug metformin tested positive for unsafe levels of a chemical called N-Nitrosodimethylamine. The agency has stepped up testing after the chemical was found in dozens of shipments of heartburn drugs last year, triggering recalls of Zantac and other popular over-the-counter and prescription medications.

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Metformin tablets are a staple of diabetes care, reducing excess sugar in the blood. People with Type 2 diabetes use metformin alone or with other drugs to help control their blood sugar levels. More than 34 million people in the U.S. have this disease.

Patients should continue taking metformin drugs until their doctor can prescribe a replacement, the FDA said in a statement, noting the risks of discontinuing. Regulators are still assessing whether the recalls will lead to shortages of metformin, but noted that a number of other companies make generic versions of the drugs that don’t appear to be affected by the issue.

Drugmaker Apotex Corp. recalled its extended-release metformin distributed in the U.S. earlier this week after the FDA found contamination in one lot. Apotex said in a statement it recalled all supplies of the drug “out of an abundance of caution.” The company said it stopped selling the drug in the U.S. in February 2019 and that little remains on the market.

The FDA announcement did not name the four other drugmakers who have been requested to recall their products.

The agency noted that no contamination problems have been found in immediate-release metformin.

The FDA is responsible for ensuring that medicines for the U.S. market are made in safe, sanitary conditions that meet federal quality standards. But government inspectors have repeatedly criticized the agency for falling short in reviewing overseas manufacturing plants as the pharmaceutical supply chain has increasingly spread to Asia.

In March, the FDA suspended nearly all U.S. and foreign inspections due to safety concerns and travel restrictions caused by the coronavirus outbreak.

HOW D’OXYVA CAN HELP?

D’OXYVA is the only fully noninvasive, completely painless over-the-skin microcirculatory and nerve stimulant solution that has been validated to significantly improve microcirculation.

The improvement of microcirculation, i.e., blood flow to the smallest blood vessels, benefits one’s health, immune system and overall sense of well-being in a variety of ways.

Reduce unwanted doctor visits, recommended and ranked top by experts!

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An interview with Dr. Michael McGlamry: Diabetic patients and Covid-19

Michael Mcglamry

About Dr. Michael McGlamry

Forsyth Foot and Ankle Associates, Cumming, GA

Dr. McGlamry was born and raised in Atlanta.  He graduated from Tucker High School in 1982, and earned a Bachelor of Science in Engineering with honors from The University of Florida. In 1991, he earned a Doctorate of Podiatric Medicine from The Penn. College of Podiatric Medicine/Temple University.

In 1991, he began his residency training in reconstructive surgery of the foot and leg at Northlake Regional Medical Center in Tucker. After completion, he started a practice in Gainesville, Fl where he practiced for 11 years.

Currently, he teaches at DeKalb Medical Center, with the residency program. He also teach on the post graduate level with the Podiatry Institute, and AO North America; both of which are renowned for their dedication to physicians’ education, and for the improvement of quality patient care.

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1. What should patients with diabetes know about COVID-19 and how it may affect them?

In the middle of a global pandemic, like the one we’re living, it is very important to be able to assess risks and try to diminish their effects. Cardiovascular disease is one of the most relevant and impactful; that is why improving blood flow and tissue oxygenation is so important for improving the health outcomes of a COVID-19 infection.

People with diabetes, especially those over 65 years of age, have been shown to be affected more often and with greater severity by coronavirus infection. Diabetic patients, particularly those with more longstanding and poorly controlled disease, suffer from diminished oxygen-rich blood in their microcirculation, which may be a major risk factor for why COVID is so deadly for them. Reports from Chinese authorities and from top American institutions, such as Harvard Medical School, show that underlying cardiovascular disease is associated with an increased risk of in-hospital death for patients hospitalized with COVID-19.

2. How does Circularity’s  over-the-counter (OTC) transdermal device helps patients with foot issues, potentially including COVID?

D’OXYVA® (deoxyhemoglobin vasodilator) is a groundbreaking noninvasive, painless transdermal delivery system based on widely established, groundbreaking, Nobel Prize-winning science and is shown to increase oxygen-rich blood flow in the local microcirculatory system, which in turn leads to better blood perfusion and tissue oxygenation. The increased peripheral perfusion plays a significant role in enhancing the wound healing process, which may lead to a reduction in the influence of preexisting conditions in cases of a coronavirus infection.

D’OXYVA has shown significant promise for severe cases of diabetic foot ulcers. Its therapeutic effects have circulatory and neurological benefits as well.

3. Tell us about CO2, microcirculation, and its effects on the body.

D’OXYVA uses ultra-purified carbon dioxide (CO2), a naturally occurring nontoxic substance, which is delivered via the D’OXYVA noninvasive skin delivery system. The CO2 acts as a signaling agent for the body to help stimulate delivery of red blood cells loaded with fresh oxygen to the peripheral tissue. D’OXYVA’s over-the-skin route of administration has demonstrated a safer, more effective alternative route to inhalation — a routine CO2 delivery method in hospitals. Purified carbon dioxide is a nontoxic molecule and can be sold by Circularity over the counter (OTC) and online without the need for a prescription. Circularity’s products are manufactured in compliance with the highest standards.

Improved microcirculation leads to better tissue oxygenation and better heart function, as the heart does not need to exert extra force to propel the blood to all the organs of the body.

4. What have clinical trials shown about how this device helps patients, especially diabetics with foot problems?

Over two dozen studies have demonstrated convincing results at clinics and in homes with no adverse events. D’OXYVA has recorded significant results, delivering major outcomes for well over 90% of users. Studies of D’OXYVA have shown unmatched results in noninvasive wound care — particularly when all other approaches have failed. D’OXYVA provides an adjunct to accelerate comprehensive wound care programs and infection protection in a painless, affordable nonprescription solution that is available in a clinical setting or in the comfort and privacy of your own home.

In an ongoing multiyear, multicountry, multicenter randomized clinical trial on patients with diabetic foot ulcers, D’OXYVA demonstrated hastened wound improvement and eventual wound closure in an average of 5 weeks**.

In addition, D’OXYVA eliminated pain and improved quality of life such as in regard to sleep, appetite, and mood in just a week in 100% of subjects.

No adverse events of any kind were reported during and for years after the studies.

5. As a Internist ­focused on prevention, what do you want diabetics to know about making their foot health a priority?

Microcirculation is often disregarded by diabetic patients, and I’d like to emphasize to them that microcirculation is important, especially in wound healing. In other words, microcirculation is the bridge between blood and single cells that supply oxygen and nutrients to human tissues, especially where it is needed the most. Without proper blood flow, their body will be prone to more complications, including the development of foot ulcers that could lead to amputation. Remember that having improved microcirculation and oxygenation promotes faster wound healing, promotes better performance, and enhances the renewal and replacement of damaged tissues.

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Reduce unwanted doctor visits, recommended and ranked top by experts!