HEALTH

FDA warns against homeopathic asthma products

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Thursday issued a warning to consumers to avoid use of over-the-counter asthma products labeled as homeopathic as "the products have not been evaluated for safety and effectiveness." 
 
The agency directed consumers to talk to their healthcare provider about a prescription asthma remedy or a nonprescription solution that is marketed OTC in accordance with an FDA monograph. 
 
The American Association of Homeopathic Pharmacists, representing the principal manufacturers and distributors of homeopathic medicines in the United States, said it fully supports the Food and Drug Administration’s position that consumers should seek the advice of their health care provider if they suspect they or their children are experiencing symptoms of asthma, which includes, but is not limited to, shortness of breath, chest tightness, wheezing and/or coughing. The AAHP supports the concern that self-treatment of suspected or diagnosed asthma without the advice of a health care provider may place consumers at risk.
 
"Consumers with diagnosed asthma should seek regular advice from their health care provider for management of intermittent and chronic asthma symptoms," the association stated. "If consumers wish to include homeopathic medicines in their asthma treatment plan, the AAHP suggests consumers seek evaluation by a homeopathic physician who has completed post-graduate medical training in the selection of homeopathic medicines for individual cases."
 
However, there aren't many OTC medications for asthma on the market. Nephron Pharmaceuticals has a recepinephrine solution on shelves called Asthmanefrin that generated $18.4 million for the 52 weeks ended Dec. 28, 2014, according to IRI data for total U.S. multi-outlets. Sales were relatively flat with a slight 0.8% lift. 
 
And it doesn't look likely that the one-time $100 million asthma-relief brand Primatene Mist will make a comeback to the marketplace. Primatene Mist had been withdrawn from the market in December 2011 when the agency removed all inhalers containing chlorofluorocarbons from the market. And a pair of FDA advisory panels in February of last year did not recommend a petition by Armstrong Pharamceuticals to approve Primatene HFA, an epinephrine inhalation aerosol indicated for the temporary relief of mild symptoms of intermittent asthma for people ages 12 years or older. 
 
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program, the agency stated. 
 

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C&D expands its First Response brand into multivitamins

BY Michael Johnsen

EWING, N.J. — Church & Dwight is leveraging its First Response brand into the dietary supplement set with the launch of First Response multivitamin gummies which target reproductive health and prenatal/post-natal need states. 
 
“First Response has been a trusted resource for women for more than 25 years, delivering her the innovative tools she needs to be prepared and knowledgeable throughout her reproductive health journey – a journey that extends well before pregnancy through post-pregnancy,” said Stacey Feldman, VP marketing, Church & Dwight. “As the category leader, First Response remains committed to reducing the anxiety faced throughout the family planning process by giving women a full breadth of products needed to make informed, healthy decisions. Expanding our portfolio to include women’s health vitamins allows us to meet yet another crucial need, extending our support throughout a woman’s reproductive years. ”
 
First Response multivitamin gummies were developed to provide women with the recommended amount of folic acid in an easy-to-consume gummy form. 
 
The two new vitamin SKUs, First Response Reproductive Health Multivitamin Gummies and PreNatal & PostNatal Multivitamin Gummies, will be available in drug, grocery and mass retailers across the country starting in April for $14.99. The First Response Reproductive Health Multivitamin Gummy is a multivitamin with essential nutrients needed for overall health and to help prepare for pregnancy (including 400 mcg of folic acid and 50mg of Omega-3 DHA).

One serving is an excellent source of iodine to support pre-pregnancy health. And the First Response PreNatal & PostNatal Multivitamin Gummy is a multivitamin that contains essential nutrients important to pregnant and nursing women (including 800 mcg of folic acid and B vitamins for energy metabolism support) and one serving is a good source of calcium for nursing mothers.

 
The supplements were developed in conjunction with C&D's Vitafusion, one of the leading gummy vitamin brands. 
 
“All women trying to get pregnant or who don’t use effective contraception 100% of the time during sex, should take a daily multivitamin with 400 mcg of folic acid,” said Mary Jane Minkin, clinical professor of obstetrics, gynecology and reproductive sciences at the Yale School of Medicine. “Folic acid has been found to be instrumental in helping to prevent neural tube defects, which often develop before a woman knows she is pregnant. The nutrients and vitamins in the First Response women’s health gummy vitamins are important for preparing a woman's body for a healthy pregnancy, even before they consider trying to conceive.”  
 
The full portfolio of First Response products includes at-home pregnancy test kits (including the Gold Digital Pregnancy Test), ovulation kits (including the Daily Digital Ovulation Test) and Pre-Seed, a sperm-friendly fertility lubricant. 
 
In addition, the First Response Tracker smartphone app offers personalized period and ovulation trackers, as well as a due date calculator.
 

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Research: Vitamin D may slow progression of low-grade prostate cancer

BY Michael Johnsen

 

DENVER — Taking vitamin D supplements could slow or even reverse the progression of less aggressive, or low-grade, prostate tumors without the need for surgery or radiation, Bruce Hollis, a researcher at the Medical University of South Carolina, reported Sunday at the 249th National Meeting & Exposition of the American Chemical Society here.
 
If a tumor is present in a prostate biopsy, a pathologist grades its aggressiveness on a scale known as the Gleason Grading System. Tumors with Gleason scores of 7 and above are considered aggressive and likely to spread, requiring surgical removal of the prostate gland (prostatectomy) or radiation therapy. In contrast, prostate tumors with Gleason scores of 6 and below are less aggressive, and in some cases may cause no symptoms or health problems for the duration of the man’s life.
 
In cases of low-grade prostate cancer, many urologists do not treat the disease, but instead do what’s called “active surveillance,” Hollis noted. “The cure — meaning surgery or radiation — is probably worse than the disease, so they wait a year and then do another biopsy to see where the patient stands.”
 
However, knowing that they have even low-grade prostate cancer can cause patients and their families excessive anxiety, which prompts some of the men to undergo an elective prostatectomy, despite the risk of complications such as infection, urinary incontinence and erectile dysfunction. But a man must wait 60 days from the time of his biopsy before he can undergo a prostatectomy, so that inflammation from the biopsy can subside.
 
Hollis wondered if giving these men vitamin D supplements during the 60-day waiting period would affect their prostate cancer. His previous research had shown that when men with low-grade prostate cancer took vitamin D supplements for a year, 55% of them showed decreased Gleason scores or even complete disappearance of their tumors compared to their biopsies a year before.
 
In a new randomized, controlled clinical trial, his team assigned 37 men undergoing elective prostatectomies either to a group that received 4,000 U of vitamin D per day, or to a placebo group that didn’t receive vitamin D. The men’s prostate glands were removed and examined 60 days later.
 
Preliminary results from this study indicate that many of the men who received vitamin D showed improvements in their prostate tumors, whereas the tumors in the placebo group either stayed the same or got worse. Also, vitamin D caused dramatic changes in the expression levels of many cell lipids and proteins, particularly those involved in inflammation. “Cancer is associated with inflammation, especially in the prostate gland,” Hollis said. “Vitamin D is really fighting this inflammation within the gland.”
 
The protein most strongly induced by vitamin D was one called growth differentiation factor 15. Previous studies by other groups showed that GDF15 dials down inflammation, and many aggressive prostate cancers make little or no GDF15.
 
The new research suggests that vitamin D supplementation may improve low-grade prostate cancers by reducing inflammation, perhaps lessening the need for eventual surgery or radiation treatment. “We don’t know yet whether vitamin D treats or prevents prostate cancer,” says Hollis. “At the minimum, what it may do is keep lower-grade prostate cancers from going ballistic.”
 
Hollis notes that the dosage of vitamin D administered in the study — 4,000 U — is well below the 10,000–20,000 U that the human body can make from daily sun exposure. “We’re treating these guys with normal body levels of vitamin D,” he said. “We haven’t even moved into the pharmacological levels yet.”
 
The researchers acknowledge funding from Gateway for Cancer Research, the Department of Veterans Affairs, National Institutes of Health and South Carolina Clinical and Translational Research Institute.
 
The American Chemical Society is a nonprofit organization chartered by the U.S. Congress. 

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