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SEC Committee Recommends Metformin SR For Gestational Diabetes; Final Approval Pending

The Endocrinology & Metabolism Subject Experts Committee (SEC), under the Central Drugs Standard Control Organization (CDSCO), recently reviewed the use of Metformin Hydrochloride Sustained-Release (SR) Tablets for the management of gestational diabetes. Following the review, the SEC has recommended the consideration of Metformin SR 500 mg & Metformin SR 1000 mg for use during pregnancy, at the treating physician's discretion, as an adjunct or alternative to insulin therapy.

Metformin is one of the most widely used first-line agent for the management of type 2 diabetes, Prediabetes and is also approved for the treatment of Polycystic Ovary Syndrome (PCOS) with established insulin resistance. Its applicability and safety during pregnancy and the peri-conceptional period were recently evaluated by the Subject Expert Committee (SEC) in the presence of gynecologists and neonatalogists as special invitees. Its use in gestational diabetes is currently under review by regulatory authority.

Based on the prescription data and already available approval in EU and UK presented by Pharma major USV Pvt limited in this special population, the committee recommended the CDSCO for grant of permission to update the proposed statement in the prescribing information of Metformin Hydrochloride SR Tablets 500mg and 1000mg.

The prescribing information for Metformin Hydrochloride SR Tablets 500mg and 1000mg will be updated to indicate that

"if clinically needed, Metformin may be considered during pregnancy or the periconceptional phase, as an addition or alternative to insulin, at the treating physician's discretion".

The final grant of approval for the change in the prescribing information is awaited from DCGI/ CDSCO and any changes to the approved labelling will be communicated accordingly. Healthcare professionals are advised to continue following current treatment guidelines until the official regulatory update is issued.

Disclaimer: "The use of Metformin during pregnancy is still under review and subject to final regulatory approval"

How Much Weight Can You Lose On Metformin, The Oral Ozempic Alternative?

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The type 2 diabetes medication Ozempic has been hugely popular when prescribed off-label for weight loss, thanks to its ability to regulate your blood sugar and curb your appetite. But between shortages, high out of pocket costs and the need for weekly injections, the medication is not suited for everyone. As an alternative, some doctors have been prescribing metformin—an oral diabetes drug—off-label for weight loss. But how does metformin work, and how much weight can you expect to lose? Here, experts explain everything you need to know. 

What is metformin?

Metformin is a prescription medication used to manage type 2 diabetes in adults. "Metformin works by decreasing glucose (sugar) production in the liver, improving the body's response to insulin and reducing glucose absorption from food in the intestines," says HaVy Ngo-Hamilton, PharmD, a pharmacist at BuzzRx. "It is FDA-approved for people with type 2 diabetes and is typically prescribed as a first-line treatment to help control blood sugar levels in patients with this disease."

While it's most often prescribed for diabetes, metformin can also be used off label to help manage polycystic ovarian syndrome (PCOS), prediabetes and obesity, says Katherine H. Saunders, MD, DABOM, obesity physician at Weill Cornell Medicine and co-founder of FlyteHealth.

Can you take metformin for weight loss?

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Metformin is not currently approved by the Food and Drug Administration for weight loss. However, metformin can contribute to modest weight reduction in diabetic and non-diabetic individuals, explains Ngo-Hamilton.

"The weight loss associated with taking metformin is likely due to decreased caloric intake rather than increasing energy expenditure," explains Eric Smith, DO, FASMBS, bariatric medical doctor at Pop Recovery Systems. He recommends consulting with your primary care provider to determine if metformin is the right medication for you.

While taking metformin for weight loss won't deliver the same impressive results as Ozempic (dropping 15-20 percent of your body weight), it can help you shed around 5 percent of your body weight within the first year. For a 200-pound person, that's 10 pounds.

How metformin aids weight loss

While it's not an official weight loss medication, metformin is worth considering if you're trying to shed stubborn pounds. Here's how metformin can support weight loss: 

Metformin curbs appetite 

"Metformin can increase certain hormones that reduce hunger, like lac-phe, a molecule that makes you feel less hungry," says Dr. Smith. Lac-phe was discovered in 2022 by Stanford University researchers, and it plays a critical role in metabolism, exercise and appetite. 

Metformin also affects the gut microbiota (the balance of beneficial and harmful organisms naturally found in your gut) and reduces food intake. "Metformin can shift the balance of bacteria in the gut, which plays a role in digestion and possibly in how the body processes and stores energy," adds Dr. Smith.

Metformin improves insulin sensitivity

Since the diabetes drug helps the body use insulin more effectively, metformin also stabilizes blood sugar and may reduce fat storage. "Excess glucose in the blood will accumulate as fat," says Ngo-Hamilton. "By getting blood sugar levels under control, metformin helps reduce fat accumulation."

A study published in the Bariatric Times found that taking metformin decreased body weight for individuals with and without diabetes.  And Dr. Smith adds that metformin also helps with glucose production. "Less glucose coming from the liver means the body needs less insulin, which may also help with less fat storage."

Side effects of taking metformin for weight loss 

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If your doctor has prescribed metformin, it's important to be aware of the potential side effects. "The most common side effects among our patients include diarrhea and constipation," says Dr. Saunders. "Other potential side effects include nausea, dyspepsia, abdominal pain, gas, headache, dizziness, muscle pain and altered taste."

Since metformin isn't approved for weight management, there's no recommended starting dose for weight loss. However, Dr. Saunders says a typical dose can range from 500 to 2,000 mg daily, and you must get a prescription from a doctor to take metformin.

Another important note: Weight loss with metformin is usually modest and not guaranteed "Lifestyle modifications, such as following a healthy diet and regularly exercising, are essential for meaningful and sustainable weight management," says Ngo-Hamilton.

For more weight loss tips

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This content is not a substitute for professional medical advice or diagnosis. Always consult your physician before pursuing any treatment plan.

Diabetes Drug Metformin, GLP-1 Meds Might Also Curb Asthma

Drugs already taken by millions of diabetes patients appear to also help slash asthma attacks by up to 70%, new research shows. Photo by Adobe Stock/HealthDay News

Drugs already taken by millions of diabetes patients appear to also help slash asthma attacks by up to 70%, new British research shows.

The two drugs are metformin, one of the most widely used diabetes medications, and the GLP-1 class of medications that include Ozempic, Mounjaro and Saxenda.

A study of nearly 13,000 people with diabetes and asthma found that metformin cut a patient's odds for asthma attacks by 30%, while adding in a GLP-1 med reduced it by another 40%.

The effects appeared to rely on more than just improved in blood sugar control or weight reduction, the authors said, and suggest that metformin and GLP-1s might work directly on airway function to ease asthma.

All in all, the findings "suggest potential for repurposing anti-diabetic. Drugs to much needed alternative treatments for asthma," said a team led by Chloe Bloom. She's a senior lecturer in respiratory epidemiology at Imperial College London.

Her team published its findings Monday in JAMA Internal Medicine.

As the researchers explained, there's long been good reason to suspect that metformin might improve asthmatics' respiratory health. The drug has anti-inflammatory effects, they said, and it also appears to reverse some of the changes in airways and the "hyper-responsiveness" of airways that asthma brings.

The data on GLP-1s shows similar effects: The same cellular receptors that the drugs work on in the brain are found in the lungs, and GLP-1s are also thought to calm airway hyper-responsiveness.

But would any of this show up in a real-world study of patients?

To find out, Bloom's team tracked the hospital records of about 12,700 Type 2 diabetes patients who also had asthma, looking for incidents of asthma attacks. They also tracked each patients' use of various diabetes medications. Data was collected from 2004 to 2020.

The results were impressive.

"Metformin was associated with a lowered risk of asthma attacks by approximately 30%," the researchers found. When patients were also prescribed a GLP-1 as an add-on therapy, that was "associated with an additional lowered risk of approximately 40%," they added.

Looking closer at the data, Bloom's team found that changes in blood sugar control or weight while on the drugs had little to do with the relationship of metformin and GLP-1 use to improvements in asthma.

They note that half of people with asthma in their study were also overweight or obese and at risk of having diagnosed or undiagnosed Type 2 diabetes.

So, the findings bring up a potentially exciting new possibility: Giving metformin or a GLP-1 to people with asthma to help treat the breathing disorder and any underlying diabetes.

There may be "a benefit of [this type of] early pharmacological intervention for adults with asthma and metabolic dysfunction," Bloom's group concluded.

They say further research, including clinical trials, is warranted to confirm the benefits seen in this study and to better understand how diabetes drugs may improve asthma care.

More information

To find out more about asthma treatments, head to the Asthma and Allergy Foundation of America.

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