Search Results for: drug approval

FDA Approves Soolantra Cream for Rosacea

Good news for those suffering from Rosacea. Galderma Laboratories’ Soolantra (ivermectin) Cream, 1% has been approved by the FDA for the once-daily topical treatment of the inflammatory lesions, bumps, and pimples of rosacea.
Rosacea is an inflammatory and vascular skin disorder affecting 16 million Americans, many of whom are women 30 years of age and older. Although the cause of rosacea is unknown, studies suggest that factors such as sun, alcohol, spicy food, and exercise can trigger the inflammation associated with the condition. Additional research has also indicated that rosacea may be connected with microscopic Demodex mites, which have been found to be more common on the faces of rosacea patients.
“Rosacea is a common and challenging condition to manage as it tends to vary from patient to patient, often requiring a tailored approach. For that reason, we are always looking for innovative new treatments,” said Linda Stein Gold, M.D., Galderma consultant. “While some rosacea treatments for the common bumps and pimples of the condition may take more than 4 weeks to show effect, Soolantra Cream may provide initial results as early as week 2.” Long-term extensions to the 12-week studies also found that Soolantra Cream was safe and well-tolerated for an additional 40 weeks (52 weeks total), a promising result for rosacea patients with sensitive skin. Some study participants reported skin burning sensation and skin irritation while using Soolantra Cream.

FDA Approves Drug for Children’s Nasal Symptoms Related to Allergic Rhinitis

A new FDA approval may soon help children with allergies seek relief from nasal symptoms. Teva’s beclomethasone dipropionate (Qnasl) 40 mcg has been approved by the FDA for treating nasal symptoms associated with allergic rhinitis (AR) among children 4 to 11 years old, according to the manufacturer’s press release.
Qnasl 40 mcg offers a lower dose formulation than the already-available Qnasl Nasal Aerosol 80 mcg, which is a waterless intranasal corticosteroid spray for individuals 12 and older with nasal problems related to AR. This approval makes Qnasl 40 mcg the only waterless hydrofluoroalkane nasal allergy treatment for children as young as 4 years old, according to Teva.
A study of Qnasl’s efficacy showed that once-daily treatment with 40 mcg of the drug provided greater nasal allergy symptom relief among children with seasonal AR and perennial AR when compared with placebo. Some common side effects were nosebleeds and ulcers.
“The approval of Qnasl for use in children aged 4 to 11 is an important advancement for an often difficult-to-treat patient group,” said Todd Mahr, MD, director of pediatric allergy and immunology at Gundersen Lutheran Medical Center in La Crosse, Wisconsin, in a press release. “Qnasl 40 mcg has several characteristics that provide prescribers with a treatment option specifically designed for children with allergic rhinitis, including its ‘waterless’ aerosol method of delivery and lower dose formulation.” Teva estimates Qnasl 40 mcg will be available by prescription in February 2015.
Source: Pharmacy Times

It’s hard to believe that another year has come and gone. We have gained new customers and new friends along the way and appreciate your loyalty. In case you’ve missed any of them, the following list shows the articles that we’ve shared in 2017. Here’s to a healthy and happy 2018.
Disease Awareness
Deep Vein Thrombosis: Learn the Risks
Shingles: Are you at risk?
Good News for those with MS
What you need to know about TB
Asthma Awareness Month
Group B Strep awareness
Diabetes Awareness Month

Drug Awareness
Final Drug Approvals from 2016
FDA Approvals for First Quarter of 2017
Prescription Drug Abuse
Endo to pull Opana from market following FDA request
Newest drug approvals – July 2017
Why it’s important to take your medications
Drug Take-back Day
FDA drug approvals for Third Quarter 2017

Personal Well-Being
Time to schedule your checkup
The health benefits of gratitude
Sinus Trouble Do’s and Don’ts
Quit Smoking Resolution
Eating Disorders
Radon: Should you test for it?
Put your best fork forward
Stevia vs. Sugar
Dehydration and Kidney Stones
Travel Safety Tips
What are hernias and what causes them?
Is it a cold, flu or allergies?
Flu prevention
Gender differences in addiction and treatment
Suicidal behavior awareness and prevention
Staying healthy during cold and flu season
Preventing Traumatic Brain Injuries

Women’s Health
Wear Red for Women’s Health
Cervical Health Awareness
Thyroid Disease in Women
Breastfeeding and vitamin deficiency
Is it time to schedule your mammogram?

Men’s Health
What you should know about testicular cancer

Senior Living
Sundowning: How to help your loved one
Cataract Awareness Month
Bone Density
Top tips for family caregivers
Medicare Part D open enrollment

Children’s Health
Managing Head Lice
Self-injury and Teenagers
Child ID Kits
Fighting Teen Addiction
Healthy eating habits for kids
 

Thank you to our loyal customers! Not only do we appreciate your support of our local pharmacies this past year, but also allowing us to serve you for the past 15 years. The following are a list of articles  from 2016 that cover everything from disease awareness and prevention, to healthy kids. Cheers to a healthy and happy 2017!
Village Pharmacy Celebrates 15 Years of Serving Hampstead
Disease Awareness
Alzheimer’s Awareness Month
Colorectol Cancer Awareness Month
Crohn’s Disease
Glaucoma Awareness Month
July 28 is World Hepatitis Day
Lupus Awareness Month
Focus on MS
Preventing and Treating Osteoporosis
Parkinson’s Disease Symptoms and Stages
Symptoms and Treatment Options for Psoriasis
Living with Rheumatoid Arthritis
Drug Awareness
The Dangers of Antibiotic Overuse
National Drug & Alcohol Abuse Week (SM)
FDA Approvals for 4th Quarter of 2015
New Drugs Approved in First Quarter of 2016
New FDA approvals in the Second Quarter of 2016
Third Quarter Drug Approvals

Personal Well-Being
Avoiding Holiday Depression
Dehydrated?
Vertigo: Beyond the Dizziness
Heart Rate: Learn your Rhythm
Should you worry about the Zika virus?
DANGER – E-Cigarettes
Plantar Fasciitis
Kidney Stones: How to prevent and treat them
What Causes Hearing Loss?
Seasonal Tips
Fall Safety Tips
Is it a cold, the flu, or allergies?
Summer Safety
Protecting your skin – What are you wearing?

Healthy Living
Avoiding Sugar
Eat Your Vitamins
National Immunization Awareness Month
Tips to Manage Stress
Weight Loss Resolution
Cholesterol: Get the Facts
Children’s Health
Is Your Child Depressed?
National Infant Immunization Health Week
Autism Awareness Month
National Childhood Obesity Awareness Month
Childhood Cancer Awareness Month
College Send Off
Causes of stress in kids
Men’s Health
Is it your bladder or your prostate?
Top Health Issues for Men
Women’s Health
Survival Mode: How to help women fighting breast cancer
Senior Care
Prevent Falls at Home
The Behaviors of Alzheimer’s
 

Thank you for allowing us to serve you in 2014. As we look back at the year, we are grateful to you, our customers, and hope you have learned from us through our blog articles. In case you’ve missed any of them or simply want to refresh your memory, here’s a glimpse of what we’ve covered this year. Click on the links below to read the full articles.

Drug Abuse Issues

Many of our customers take vitamins to supplement their diet. However, before you reach for that bottle of vitamin C or fish oil pills, ask yourself whether you need them in the first place.
More than half of all Americans take one or more dietary supplements daily or on occasion and are available without a prescription. Common supplements include vitamins, minerals and herbal products, also known as botanicals. People take these supplements to make sure they get enough essential nutrients and to maintain or improve their health. But not everyone needs to take supplements.
“It’s possible to get all of the nutrients you need by eating a variety of healthy foods, so you don’t have to take one,” says Carol Haggans, a registered dietitian and consultant to the National Institutes of Health. “But supplements can be useful for filling in gaps in your diet.”
Some supplements may have side effects, especially if taken before surgery or with other medicines. Supplements can also cause problems if you have certain health conditions. And the effects of many supplements haven’t been tested in children, pregnant women and other groups. So talk with your doctor or pharmacist if you’re thinking about taking dietary supplements.
“You should discuss with your doctor what supplements you’re taking so your care can be integrated and managed,” advises Dr. Craig Hopp, an expert in botanicals research at NIH.
Dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods, not as drugs. The label may claim certain health benefits. But unlike medicines, supplements can’t claim to cure, treat or prevent a disease. “There’s little evidence that any supplement can reverse the course of any chronic disease,” says Hopp. “Don’t take supplements with that expectation.”
Evidence does suggest that some supplements can enhance health in different ways. The most popular nutrient supplements are multivitamins, calcium and vitamins B, C and D. Calcium supports bone health, and vitamin D helps the body absorb calcium. Vitamins C and E are antioxidants—molecules that prevent cell damage and help to maintain health.
Women need iron during pregnancy, and breastfed infants need vitamin D. Folic acid—400 micrograms daily, whether from supplements or fortified food—is important for all women of childbearing age.
Vitamin B12 keeps nerve and blood cells healthy. “Vitamin B12 mostly comes from meat, fish and dairy foods, so vegans may consider taking a supplement to be sure to get enough of it,” Haggans says.
Research suggests that fish oil can promote heart health. Of the supplements not derived from vitamins and minerals, Hopp says, “fish oil probably has the most scientific evidence to support its use.”
The health effects of some other common supplements need more study. These include glucosamine (for joint pain) and herbal supplements such as echinacea (immune health) and flaxseed oil (digestion).
Many supplements have mild effects with few risks. But use caution. Vitamin K, for example, will reduce the ability of blood thinners to work. Ginkgo can increase blood thinning. The herb St. John’s wort is sometimes used to ease depression, anxiety or nerve pain, but it can also speed the breakdown of many drugs—such as antidepressants and birth control pills—and make them less effective. Just because a supplement is promoted as “natural” doesn’t necessarily mean it’s safe. The herbs comfrey and kava, for example, can seriously damage the liver.
“It’s important to know the chemical makeup, how it’s prepared, and how it works in the body—especially for herbs, but also for nutrients,” says Haggans. “Talk to a health care provider for advice on whether you need a supplement in the first place, the dose and possible interactions with medicine you’re already taking.”
For vitamins and minerals, check the % Daily Value (DV) for each nutrient to make sure you’re not getting too much. “It’s important to consider the DV and upper limit,” says Haggans. Too much of certain supplements can be harmful.
Because supplements are regulated as foods, not as drugs, the FDA doesn’t evaluate the quality of supplements or assess their effects on the body. If a product is found to be unsafe after it reaches the market, the FDA can restrict or ban its use.
Manufacturers are also responsible for the product’s purity, and they must accurately list ingredients and their amounts. But there’s no regulatory agency that makes sure that labels match what’s in the bottles. You risk getting less, or sometimes more, of the listed ingredients. All of the ingredients may not even be listed.
A few independent organizations conduct quality tests of supplements and offer seals of approval. This doesn’t guarantee the product works or is safe; it just assures the product was properly made and contains the listed ingredients.
“Products sold nationally in the stores and online where you usually shop should be fine,” Coates says. “According to the FDA, supplement products most likely to be contaminated with pharmaceutical ingredients are herbal remedies promoted for weight loss and for sexual or athletic performance enhancement.”
For more personalized, on-the-go information about dietary supplements, check out NIH’s free updated app for your smart phone or tablet: My Dietary Supplements (MyDS). You can access it at https://myds.nih.gov.
The MyDS app provides the latest supplement information and lets you keep track of the vitamins, minerals, herbs and other products you take. You can even keep track of supplements taken by your parents, spouse or children.
“Deciding whether to take dietary supplements and which ones to take is a serious matter,” says Coates. “Learn about their potential benefits and any risks they may pose first. Speak to your health care providers about products of interest and decide together what might be best for you to take, if anything, for your overall health.”
 
Source: National Institutes of Health