ALLERGY, RESPIRATORY
Know Your Asthma Triggers
Childhood Food Allergies on the Rise
Traffic, Dust Linked to Asthma in Kids
ALTERNATIVE MEDICINE
Maggots as Good as Gel in Leg Ulcer Treatments
Taking the Mystery Out of Hypnotherapy
Soybean Chemicals May Reduce Effects of Menopause
ANIMAL CARE
Rest Easy. When It Comes to Swine Flu, Your Pet Is Safe
Safe Toys for Dogs
Beware of Dog Bites
BONES & JOINTS
Studies Struggle to Gauge Glucosamine's Worth
Fruits and Veggies May Strengthen Bones
'Snowbirds' Beware the Climate Changes
CANCER
Supplements Might Reduce Breast Cancer Risk
Seaweed May Help Treat Lymphoma
Method for Treating Cervical Lesions May Pose Pregnancy Risks
CAREGIVING
Baby's Sleep Position May Not Affect Severity of Head Flattening
Stressed Health Care Workers Battle 'Compassion Fatigue'
ER Less Likely to Diagnose Stroke in Younger Folks
CIRCULATORY SYSTEM
Bad Marriages Harder on Women's Health
Obesity Linked to Heart Failure Risk
Mercury in Fish Linked to High Blood Pressure
COSMETIC
Contact Lenses Boost Kids' Self-Image
Get Sugared!.... Its a sweet choice for hair removal
With Psoriasis, the Internet May Offer Hope
DENTAL, ORAL
Holistic Dentistry-My View
Health Tip: At Risk for Gingivitis
Rheumatoid Arthritis May Harm Gums
DIABETES
Formula Puts Doctor, Patient Glucose Readings on Same Page
Study Shows Turmeric May Prevent Type 2 Diabetes
Patients' Photos Help Boost Radiologists' Accuracy
DIET, NUTRITION
'Organic' May Not Mean Healthier
Compound in Berries May Lessen Sun Damage
Cinnamon Breaks Up Brain Plaques, May Hold Key to Fighting Alzheimer’s
DISABILITIES
Could Your Cell Phone Help Shield You From Alzheimer's?
Review Finds Marijuana May Help MS Patients
ENVIRONMENTAL HEALTH
Pilots May Face Greater Cancer Risk
Where You Live May Affect Your Cancer Diagnosis
EPA Alerts Seniors to Carbon Monoxide Dangers
EYE CARE, VISION
Certain Diabetes Drugs May Pose Eye Risk
Music Can Help Restore Stroke Patients' Sight
Autistic Children Make Limited Eye Contact
FITNESS
Good Warm-Ups Could Halve Sports Injuries
Fitness Fades Fast After 45
Simple Steps Get Walkers Moving
GASTROINTESTINAL PROBLEMS
Peppermint Oil, Fiber Can Fight Irritable Bowel
Traditional Nonsurgical GERD Treatments Not Impressive
Soothing Imagery May Help Rid Some Kids of Stomach Pain
GENERAL HEALTH
Living With Less TV, More Sweat Boosts Weight Loss
Want Sun Protection? Wear Red or Blue
Lose Weight, Sleep Apnea May Improve
HEAD & NECK
Many Children Will Outgrow Headaches
Zen May Thicken Brain, Thwart Pain
Ski Helmets Encouraged for All
HEALTH & TECHNOLOGY
Airport Full Body Scanners Pose No Health Threat: Experts
Combating Myths About Seasonal Allergies
Save Your Aging Brain, Try Surfing The Web
HEARING
Noise Hurts Men's Hearing More, Study Shows
Summer Sounds Can Lead to Hearing Loss
HEART & CARDIOVASCULAR
Obese People Seem to Do Better With Heart Disease
Shedding Light on Why Omega-3 Fatty Acids May Help the Heart
Vitamin B3 May Help Repair Brain After a Stroke
INFECTIOUS DISEASE
Swine Flu Loves a Crowd
Swine Flu Closes Three Schools in NYC
The HPV Vaccine: Preventative Medicine or Human Sacrifice?
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Exercise During Pregnancy Keeps Newborn Size Normal
Scary Toxins Make Halloween Face Paints Questionable
Most Depressed Teens Don't Get Treatment
MEN'S HEALTH
Sunlight May Help Protect Men From Kidney Cancer
Lots of Sex May Prevent Erectile Dysfunction
Could Chinese Herb Be a Natural Viagra?
MENTAL HEALTH
Brain Scans Show How Humans 'Hear' Emotion
Keeping Mentally Active Seems To Keep The Brain Active
Estrogen May Help Men's Hearts
PAIN
'Cell Phone Elbow' -- A New Ill for the Wired Age
Tai Chi May Help Ease Fibromyalgia
Alleviating Rheumatoid Arthritis
PHYSICAL THERAPY
PREGNANCY
Breast-Feeding May Protect a Woman's Heart
Heart Defects in Newborns Linked to Antidepressants
Music of Mozart Soothes the Preemie Baby
SENIORS
Older Adults May Have Some Immunity to Swine Flu
Friends, Not Grandkids, Key to Happy Retirement
Mediterranean Diet Plus Exercise Lowers Alzheimer's Risk
SEXUAL HEALTH
SLEEP DISORDERS
Sleeping Could Help Women Lose The Baby Fat
Lose Weight, Sleep Apnea May Improve
Better Sleep, Grades Seem to Go Up
WOMEN'S HEALTH
Vitamin D Good for Breast Cancer Patients
Broccoli May Help Battle Breast Cancer
Whole Grains, Bran May Fight Hypertension in Men
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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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