Popular diabetes drug can cause side effects: Study
NEW DELHI: Prolonged use of frontline blockbuster diabetic drug metformin can lead to side effects including reduced mental abilities, depression, breathlessness and extreme fatigue. A latest government-funded study on Indian population shows the drug triggers deficiency of vitamin B12 leading to neuropathy and microvascular complication and in the absence of regular nutritional diet and supplement, patients with type 2 diabetes can suffer serious side effects.
According to doctors and researchers, Vitamin B12 deficiency is common among Indians, who are mostly vegetarian or do not have animal products as part of their regular diet.
"Intake of metformin further reduces the absorption of Vitamin B12. A prolonged B12 deficiency can cause mental disabilities, slowness, forgetfulness etc," Dr Atul Gogia, research author and consultant, Internal Medicine at Ganga Ram Hospital said.
Besides supplementation by tablets, animal products like fish and meat, and greens and beans are rich in Vitamin B12.
There were 66.8 million cases of diabetes in India in 2014. While metformin is the first drug prescribed to more than 90% of type 2 diabetics, doctors say there are over 500 brands of the drug available in the market in various combinations.
"Quality control of these combination products is not good. In terms of efficacy, all the brands are not similar," says leading endocrinologist Anoop Misra, who is also chairman of Fortis C Doc.
As part of the latest cross-sectional research conducted by New Delhi's Ganga Ram Hospital and Maharaja Sayajirao University of Baroda, 144 adults with type 2 diabetics were assessed for nutritional status and biophysical measurements. The study was funded by Indian Council of Medical Research, a government institution.
Vitamin B12 deficiency was recorded in 36% of the adults between 30-96 years, the research revealed. It also found that B12 deficiency was more in females, with 30% of female subjects found with very low B12 levels. More than one-fourth reported anorexia and metallic taste as metformin side effects.
The research recommended efficacy trials for B12 supplementation among type 2 diabetic adults.
"Addressing B12 deficiency seems crucial as regards metformin side effects and glycemic control to further prevent deterioration in quality of life due to neuropathy," Dr Gogia said.
http://timesofindia.indiatimes.com/india/Popular-diabetes-drug-can-cause-side-effects-Study/articleshow/46350264.cms
Metformin causes vitamin B12 deficiency
Sunday, October 31, 2010 by: David Gutierrez, staff writerTags: Metformin, vitamin B12, health news
NaturalNews) Long-term use of the popular diabetes drug metformin (originally marketed as Glucophage) may cause patients to develop a steadily worsening vitamin B12 deficiency, Dutch scientists have found.
"Our study shows that this decrease is not a transitory phenomenon, but persists and grows over time," wrote the Maastricht University Medical Center researchers in the British Medical Journal.
This is an issue of particular concern given the prevalence of diabetes and the popularity of metformin as a treatment.
"Metformin is considered a cornerstone in the treatment of diabetes and is the most frequently prescribed first line therapy for individuals with type 2 diabetes," the researchers wrote. "In addition, it is one of a few ... associated with improvements in cardiovascular morbidity and mortality, which is a major cause of death in patients with type 2 diabetes."
Earlier, short-term studies had found that use of the drug might lead to insufficient levels of the vitamin in the body. The new study confirmed this trend over the long term.
"Metformin does ... induce vitamin B12 malabsorption, which may increase the risk of developing vitamin B12 deficiency -- a clinically important and treatable condition," the researchers wrote.
The researchers assigned 390 Type 2 diabetes patients at the outpatient clinics of three nonacademic hospitals to take either metformin or a placebo pill three times per day for more than four years. The average study participant had been diagnosed with diabetes 13 years prior and had been undergoing insulin treatment for seven years. Average participant age was 61.
Among those taking metformin, vitamin B12 levels began to steadily drop relative to those who were taking a placebo pill. The biggest drop occurred in the first few months, but the decrease continued over the course of the study.
After four years, participants in the metformin group had undergone a 19 percent relative reduction in their levels of the nutrient. They were 11.2 percent more likely than placebo participants to suffer from B12 insufficiency and 7.2 percent more likely to suffer from deficiency.
For every 8.9 patients treated with metformin, one would develop insufficient vitamin B12 levels. This increased risk remained after researchers adjusted for other risk factors including age, duration of diabetes, insulin dose, sex, smoking status and previous treatment with metformin.
"Our study shows that it is reasonable to assume harm will eventually occur in some patients with metformin-induced low vitamin B12 levels," the researchers wrote.
The researchers found that metformin seems to inhibit the intestine's absorption of vitamin B12. Fortunately, calcium supplements appear to reverse this effect.
Vitamin B12 is critical for maintaining nerve and red blood cell health. It can be found in animal products, nutritional yeast and fortified breakfast cereals. Symptoms of deficiency include anemia, fatigue, nerve damage and cognitive changes. Because similar symptoms often occur in diabetics and the elderly, deficiency may be hard to detect in such populations. Yet while B12 deficiency can carry severe consequences, it is relatively easy to correct with supplementation.
The researchers suggested that all patients taking metformin have their vitamin B12 levels tested regularly to avoid potentially severe consequences.
"Vitamin B-12 deficiency is preventable; therefore, our findings suggest that regular measurement of vitamin B-12 concentrations during long-term metformin treatment should be strongly considered." the researchers wrote.
Nearly 11 percent of the U.S. population, or 24 million people, suffer from diabetes. Of these 5.7 million are undiagnosed. In addition, 57 million people in the United States alone are estimated to be pre-diabetic, or at imminent risk of developing the disease.
Worldwide, an estimated 246 million people suffer from the disease. Prevalence is only expected to increase as the spreading Western diet and lifestyle lead to increasing rates of obesity.
Learn more: http://www.naturalnews.com/030234_Metformin_vitamin_B12.html#ixzz43zNFh2os
Combo drugs bite into patients' pockets
CHENNAI: When S Manivalan, 77, went to a pharmacist to get his monthly dose of metformin, an anti-diabetes medicine, he was surprised when the bill was much more than usual.
When he asked, the pharmacist pointed to the almost illegible scribble against the drug in the prescription that said 'sr'. It stood for 'sustained relief'. The tweak in the drug kept it outside the price control regime. A 10-tablet strip of Metformin costs 29, while Metformin-sr costs 42.
For the pharma sector, combination drugs may be a tactic to spike their profit margin by crores, but for customers who depend on these drugs, a 20 difference is a burden.
"Every month, our family budget is planned according to our medical expense. Even a marginal rise in our medication means we have to cut down on other things," said Manivalan, whose wife has high blood pressure and cholesterol. The couple's monthly expenditure on medicines comes to 1,500. "Every time we go to buy medicine, the pharmacist tells us there's a new drug in the market that combines two of my medicines in the same dosage," said the retired teacher.
Combination drugs include two or more active pharmaceutical ingredients combined in a single dose. With more than 450 drug formulations under the National Pharmaceutical Pricing Authority's control, manufacturers are not just reducing supply of some critical drugs that come under the list, but also using their agents to push for combination drugs.
Diabetologist Dr Anand Moses said combination drugs are often pushed under the pretext of patients' convenience. "Instead of popping two pills, they can have one. As doctors, it is impossible for us to find out if this claim is true," he said. "Besides, many general physicians are unaware of the difference in price of these drugs and they prescribe based on availability and what they think is marketed well," he added.
Medical representatives say pharma companies have been pushing for these combination drugs, making use of the loopholes in the country's drug policy. "India is among the few countries where combination drugs comprise such a huge share of the drugs market," said H Sriram, working committee member of Federation of Medical Representatives Association of India (FMRAI). Experts say the efficacy was these drugs are still ambiguous.
While Mumbai and Delhi have reported a critical shortage of essential drugs used for treating cancer, thyroid and liver ailments, state drug controller Abdul Khader denied a similar shortage in Chennai. "We routinely visit pharmacies, and in case of a shortage we will report it to NPPA," he said.
http://timesofindia.indiatimes.com/city/chennai/Combo-drugs-bite-into-patients-pockets/articleshow/45555355.cms
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