Abbott receives regulatory approval for FreeStyle Lite test strips
ALAMEDA, Calif. The Food and Drug Administration approved blood-glucose test strips from Abbott.
Abbott’s new FreeStyle Lite test strips use an enzyme which is unaffected by common nonglucose sugars, such as maltose or galactose, and minimizes the potential for other interference, Abbott said. The strips also are compatible with the company’s FreeStyle Lite blood-glucose monitoring systems.
“The new FreeStyle Lite test strips represent Abbott’s latest success in delivering innovative products for people living with diabetes,” said Heather Mason, SVP Abbott Diabetes Care. “Abbott is delivering on what patients and healthcare professionals demand in diabetes care, especially for people who use insulin to manage their diabetes.”
FreeStyle Lite test strips will be available in July.
Study: Metformin may cause vitamin B12 deficiency
NEW YORK A commonly prescribed diabetes drug may cause a vitamin deficiency over time, a new study found.
Dutch scientists, led by Coen Stehouwer of Maastricht University Medical Center in the Netherlands, found that prolonged use of metformin to treat diabetes may drive down vitamin B12 levels in diabetic patients.
The study, which was published in the British Medical Journal, reviewed 390 patients with Type 2 diabetes. Of the group, 196 of them were administered metformin three times a day for more than four years. The remaining 194 patients were given a placebo. Stehouwer and colleagues found that 19% of the subjects had reduced B12 vitamin levels and progressively worsened over time, compared with the placebo group, which had almost no change.
“Our study shows that it is reasonable to assume harm will eventually occur in some patients with metformin-induced low vitamin B12 levels,” Stehouwer wrote.
In related news, a recent study published late last month found that diabetic nephropathy patients that receive high-dose vitamin B therapy are more likely to have decreased kidney function and an increased risk of heart attack and stroke.
SIDI Working Group releases CoA guideline for dietary supplement makers
WASHINGTON The Joint Standardized Information on Dietary Supplement Ingredients Working Group — a coalition of the dietary supplement industry’s trade associations — on Thursday announced the release of the new Certificate of Analysis guideline, the latest in a series of voluntary guidelines for the supplement industry, developed to assist finished product manufacturers with the complex process of qualifying their ingredient suppliers.
The voluntary CoA guideline outlines the type and scope of information that should appear on a CoA provided by an ingredient supplier to its finished product manufacturer for a component or ingredient used in a dietary supplement.
“A requirement of the supplier qualification process involves verifying the information provided in an ingredient CoA, and manufacturers of dietary supplements rely on supplier CoAs to ensure finished products are GMP-compliant,” stated Andrew Shao, a spokesperson for the SIDI Working Group and SVP scientific & regulatory affairs at the Council for Responsible Nutrition. “It’s essential for ingredient suppliers to have a form that can be consistently used, containing the appropriate information in a clear and concise format. … By standardizing the information on CoAs, this voluntary guideline will benefit both ingredient suppliers and dietary supplement manufacturers.”
The voluntary CoA guideline, along with sample CoA templates for botanical and non-botanical ingredients, is available on the five trade associations’ websites, along with the original SIDI protocol materials.
The SIDI Working Group is a cooperative effort run by the dietary supplement industry trade associations including the American Herbal Products Association, the Consumer Healthcare Products Association, CRN, the Natural Products Association and the United Natural Products Alliance.