Articles Tagged with FDA

new-brestmilk-device-300x200As matured human beings, we generally have a plethora of options when it comes to where we receive our nutrients, but for those in the fragile first 12 months of life, the choices are severely limited. Basically, the choices come down to either the less nutrient sufficient formula, or the more nutrient complex breast milk. So those who desire a more nutrient-rich diet for their infant will generally have to choose breast milk.

Recently the U.S. Food and Drug Administration permitted marketing of the Miris Human Milk Analyzer after reviewing it through the De Novo premarket review pathway, a regulatory pathway for new low-to-moderate-risk devices. This device and diagnostic test is designed to examine breast milk in order to accurately measure its nutrient composition. Breast milk composition will often vary depending on the individual, and so a test which can examine their nutritional value can be a valuable guide. The findings from this test can include concentrations of fat, carbohydrate, protein, total solids, and energy; providing healthcare professionals and parents of newborns with vital information.

The Miris Human Milk Analyzer is a prescription device used by professionals that operates by analyzing samples of human milk through an infrared spectroscopy system. This system will produce quantitative measurements of the contents contained in the milk. There are conditions that limit the information taken by the machine though, such as an interference from medication that is generally used by nursing mothers.

Harmful drugs are commonly found in dietary supplements people take for weight loss, or muscle building, sexual enhancement or general health according to a new analysis. When California health department researchers took a closer look at more than 700 supplements subject to warnings from the FDA over a 10-year span, they often found drugs like sildenafil (Viagra), the heart drug sibutramine, and synthetic steroids, all of which could be harmful.

50% of adults in the U.S.  consume dietary supplements, which is now a $35 billion industry. These supplements include vitamins, minerals, botanicals, amino acids, and enzymes that according to the US Food and Drug Administration (FDA) are not intended to treat or prevent disease.  In the recent study, c ertain drug ingredients were commonly detected across products marketed for the same purposes . Overall, 287 of 353 adulterated sexual enhancement supplements (81.3%) contained sildenafil (166 of 353 [47.0%]) and/or at least 1 of its structural analogues (134 of 353 [38.0%]). Sildenafil is the active pharmaceutical ingredient in Viagra, which is a prescription medication manufactured by Pfizer Inc for erectile dysfunction. Analogues are metabolized in the body into active pharmaceutical ingredients. In the beginning of the 10-year period from 2007 through 2016, analogues of sildenafil were detected in a majority of adulterated sexual enhancement supplements (Figure 2). In 2012, however, the proportion of products containing sildenafil began to increase.

Harvard’s Dr. Pieter Cohen — who penned a commentary that accompanies the study — says the FDA’s “dereliction of duty” is to blame for tainted supplements still on the market. He says that the FDA plays an essential role in ensuring the safety of vitamins.  He also suggests that there are major deficiencies in the FDA’s regulation of supplements.

A recent study at the Primary Children’s Medical Center in salt Lake showed that a majority of drugs used in the pediatric intensive care unit (PICU), are used in an off-label manner, exposing the patients to meds that may not have been studied in children. Of 335 drugs used in a PICU over a 5-month period, 75% were used off label at least once and nearly all of the patients, 96%, received a drug off label at least once. In the study, a drug was considered used off label when it was prescribed for a patient whose age was not listed on the label, when no pharmacokinetic data were listed for the patient’s age, or when the drug was used for an indication not approved by the FDA.The medications most likely to be used off-label based on drug orders were morphine (268), ondansetron (144), metoclopramide (141), dopamine (130), and fentanyl (127).