ALLERGY, RESPIRATORY
Obesity May Raise Kids' Allergy Risk
Herbal Remedy Could Halt Peanut Allergy
New Spray Could Benefit Cystic Fibrosis Patients
ALTERNATIVE MEDICINE
Holistic Treatment for Candida Infection
Indian Spice May Thwart Liver Damage
New Insights Show Ginseng Fights Inflammation
ANIMAL CARE
'Comfort Dogs' Come to Emotional Rescue
Safe Toys for Dogs
Separation Anxiety, Canine-Style
BONES & JOINTS
Many Americans Fall Short on Their Vitamin D
Stem Cells Might Treat Tough Fractures
Studies Struggle to Gauge Glucosamine's Worth
CANCER
Study Suggests Link Between Cell Phones and Brain Tumors
Supplement Hampers Thyroid Cancer Treatment
Breast Self-Exam Rates Go Up With Counseling
CAREGIVING
Caregivers Face Multiple Strains Tending Older Parents
Hospital Practices Influence Which Moms Will Breast-Feed
Exercise During Pregnancy May Help Baby
CIRCULATORY SYSTEM
Night Shift Work Hard on the Heart
Obesity Linked to Heart Failure Risk
A Brisk Pace May Keep Stroke at Bay
COSMETIC
Health Tip: After Liposuction
Gum Chewing May Cut Craving for Snacks
Contact Lenses Boost Kids' Self-Image
DENTAL, ORAL
Acid Drinks Blamed for Increase in Tooth Erosion
Obesity Boosts Gum Disease Risk
Amino Acid May Be Key to Strong Teeth
DIABETES
'Standard' Glucose Test May Be Wrong One for Obese Children
Abnormal Heart Rhythm Boosts Death Risk for Diabetics
Spices, Herbs Boost Health for Diabetics
DIET, NUTRITION
Heart Disease May Be Prevented By Taking Fish Oils, Study Shows
Soluble Fiber, But Not Bran, Soothes Irritable Bowel
Mediterranean Diet Helps Protect Aging Brain
DISABILITIES
Review Finds Marijuana May Help MS Patients
Could Your Cell Phone Help Shield You From Alzheimer's?
ENVIRONMENTAL HEALTH
EPA Alerts Seniors to Carbon Monoxide Dangers
Freckles, Moles May Indicate Risk for Eye Cancer
Most Mt. Everest Deaths Occur Near Summit During Descent
EYE CARE, VISION
Kids Who Spend More Time Outdoors Have Better Vision
Cases of Age-Related Farsightedness to Soar
When Corks Fly, Watch the Eyes
FITNESS
Weak Muscles May Cause 'Runner's Knee'
Any Exercise Good After a Heart Attack
Vigorous Treadmill Workout Curbs Appetite Hormones
GASTROINTESTINAL PROBLEMS
Soothing Imagery May Help Rid Some Kids of Stomach Pain
Peppermint Oil, Fiber Can Fight Irritable Bowel
Gum Chewing May Speed Colon Surgery Recovery
GENERAL HEALTH
Why Am I So Tired? Could It Be Low Thyroid?
Play Creatively as a Kid, Be a Healthier Adult
To Quit Smoking, Try Logging On
HEAD & NECK
Many Children Will Outgrow Headaches
Zen May Thicken Brain, Thwart Pain
Ski Helmets Encouraged for All
HEALTH & TECHNOLOGY
Combating Myths About Seasonal Allergies
Study Suggests Link Between Cell Phones and Brain Tumors
Subway Defibrillators Save Lives
HEARING
Noise Hurts Men's Hearing More, Study Shows
Summer Sounds Can Lead to Hearing Loss
HEART & CARDIOVASCULAR
Man's Best Friend Helps Mend Broken Hearts
Chinese Red Yeast Rice May Prevent Heart Attack
Ingredient in Dark Chocolate Could Guard Against Stroke
INFECTIOUS DISEASE
Viral Infection Might Trigger High Blood Pressure
Swine Flu Closes Three Schools in NYC
Surgical Masks Could Prevent Flu, Maybe
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Fussy Babys Could Be Out Of Your Control
Dangerous Toys Still on Store Shelves, Report Finds
Teen Stress May Have Roots in First Three Years of Life
MEN'S HEALTH
Low Iron Levels Cut Cancer Risk in Men With PAD
Could Chinese Herb Be a Natural Viagra?
Soy Linked to Low Sperm Count
MENTAL HEALTH
Love Hormone May Ease Discussion of Painful Topics
Have a Goal in Life? You Might Live Longer
A Simple 'Thank You' Brings Rewards to All
PAIN
'Cell Phone Elbow' -- A New Ill for the Wired Age
Are We Exercising Pain Away? Not So Much.
Tai Chi May Help Ease Fibromyalgia
PHYSICAL THERAPY
PREGNANCY
Sugary Colas Tied to Gestational Diabetes
Music of Mozart Soothes the Preemie Baby
Heart Defects in Newborns Linked to Antidepressants
SENIORS
Mediterranean Diet Plus Exercise Lowers Alzheimer's Risk
15-Point Test Gauges Alzheimer's Risk
Daily dose of beet juice promotes brain health in older adults
SEXUAL HEALTH
SLEEP DISORDERS
Pay Attention to Signs That Say You're Too Fatigued to Drive
6 to 8 Hours of Shut-Eye Is Optimal for Health
Better Sleep, Grades Seem to Go Up
WOMEN'S HEALTH
Calcium Helps Ward Off Colon Cancer
Supportive Weigh-In Program Keeps Pounds Off
Vitamin D Deficiency Puts 40% of U.S. Infants and Toddlers At Risk
Add your Article

FDA Goes After Unapproved Eye Washes, Skin Ointments

By Steven Reinberg
HealthDay Reporter

TUESDAY, Sept. 23 (HealthDay News) -- The U.S. Food and Drug Administration has warned companies making unapproved eye wash solutions and a widely used but unapproved skin cream to stop making and marketing the products or face enforcement actions.

The agency took this action Tuesday because of reports of serious adverse events linked to these prescription products.

"Those manufacturers and distributors who do not comply with today's notices after Nov. 24, 2008, will be subject to enforcement action such as seizure or injunction," Deborah M. Autor, director of the FDA's Office of Compliance in the Center for Drug Evaluation and Research, said during a morning teleconference.

Ophthalmic balanced salt solutions are used to irrigate the eye during procedures such as cataract and other eye operations. Reports of adverse effects include eye inflammation, cloudy vision, and even blindness. These same consequences can occur with approved versions of these products, Autor said.

Two companies, Alcon Surgical and Akorn Inc., sell approved balanced salt solution products, which are not subject to this FDA action, Autor said. The companies making unapproved eye wash products are B. Braun in Bethlehem, Pa., Baxter Healthcare in Deerfield, Ill., and Hospira Inc. of Lake Forest, Ill., she said.

Skin creams containing papain are prescribed to treat conditions such as diabetic ulcers, pressure ulcers, varicose ulcers, and traumatic infected wounds. These products remove dead or contaminated tissue from the wounds. "Firms marketing these products have not shown them to be safe and effective," Autor said.

No topical drug products containing papain have been approved by the FDA, officials said.

Adverse reactions associated with these ointments include allergic reactions that can lead to low blood pressure and rapid heart rate. In addition, people who are allergic to latex may also be allergic to papaya, the source of papain, and be at increased risk for adverse reactions to papain drug products.

Trade names for these products include Accuzyme, Allanfil, Allanzyme, Ethezyme, Gladase, Kovia, Panafil, Pap Urea, and Ziox. There are a number of products that are safe and effective for wound healing that do not contain papain, the FDA said.

More information

For more on unapproved drugs, visit the U.S. Food and Drug Administration.



SOURCE: Sept. 23, 2008, teleconference with Deborah M. Autor, director, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Last Updated: Sept. 23, 2008

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