FDA advisory panel to consider OTC status of NSAIDs
SILVER SPRING, Md. — A pair of Food and Drug Administration advisory committees will be meeting Feb. 10 to talk about heart risks associated with use of NSAIDs and whether or not Bayer’s Aleve (naproxen) carries a lower risk profile than other NSAIDs. The FDA is also considering potentially revoking OTC status of certain nonprescription NSAIDS, according to published reports.
However, the lower doses of OTC pain relievers relative to prescription-only and the short duration those pain relievers are supposed to be used to alleviate acute pain could be factors in favor of keeping ibuprofen, ketoprofen and naproxen as nonprescription pain relief options.
In addition, FDA is asking advisers to consider whether an ongoing safety study of Pfizer’s Celebrex as compared to ibuprofen and naproxen should continue as naproxen is seen as safer.
The labeling for non‐prescription NSAIDs was revised in 2005 to include more specific information about potential cardiovascular and GI risks following the recalls of cox-2 inhibitors Vioxx and Bextra.
Three NSAIDs are approved in the U.S. for over-the-counter use: ibuprofen at doses up to 1,200mg/day, ketoprofen at doses up to 75 mg/day and naproxen at doses up to 660 mg/day.
CRN addresses study claiming children’s vitamins generally exceed RDAs
NEW YORK — The Council for Responsible Nutrition on Monday helped to tone down the conclusions of a recent study reported by Reuters Health that found vitamin supplements marketed for infants and children contained more than the recommended amount of individual vitamins.
Specifically, the study found that supplements marketed for older children contained five times the recommended amount of vitamin C. And the average amount of biotin in children’s supplements was as much as nine times the RDA.
According to the report, researchers found that in all but one case (vitamin D) the average vitamin content of those supplements exceeded what’s recommended. "What we did is compare what’s on the labels for [children’s vitamins] to the recommended daily allowance or adequate intake," Michael Madden, lead author of the study from the Lake Erie College of Osteopathic Medicine, told Reuters Health.
However, the study did not identify any health concerns with use of the children’s supplements.
According to CRN SVP scientific and regulatory affairs Duffy MacKay, the recommended daily allowances as issued by the Institute of Medicine haven’t been updated recently. Further, he suggested to Reuters Health, the new study did not distinguish between multivitamins and single-letter vitamins. "There are reasons why some of the vitamins would contain more than the RDA," he said. For instance, single vitamin supplements could be made for kids who are deficient in that particular vitamin.
MacKay recommended parents read the supplement label and ascertain whether or not to give the supplement to their children after talking to their pediatrician.
MarketsandMarkets projects the nutraceutical ingredient market to reach $33.6 billion by 2018
DALLAS — MarketsandMarkets projects the nutraceutical ingredient market will grow from $23.8 billion in 2013 to $33.6 billion in 2018, with a compound annual growth rate of 7.2%, according to a report released Tuesday.
Growing awareness and reliability on the nutraceutical products is offering a strong consumer base for the market, the company noted. Nutraceutical ingredients are essential for various health purposes and prevent chronic diseases that may occur due to lack of required nutrients in the body. With changing lifestyles, consumers are tilted towards healthy diet and are more concerned about the consumption of healthy nutrients due to fear of deficiency and chronic diseases. "Therefore, the market for these ingredients is getting a push and is served with wide opportunities," MarketsandMarkets stated.
Dietary supplements form the major application of nutraceutical ingredients. The market for dietary supplements is expected to reach $13 billion by 2018, whereas a functional beverage is expected to experience the highest growth rate of 7.4% from 2013 to 2018.