ALLERGY, RESPIRATORY
Air Quality Better in Northeast, Midwest
Folic Acid Might Offer Allergy Relief
Keep Asthma, Allergies at Bay for the Holidays
ALTERNATIVE MEDICINE
Placebo Acupuncture Tied to Higher IVF Pregnancies
Meditation, Yoga Might Switch Off Stress Genes
The Zen Way to Pain Relief
ANIMAL CARE
Rest Easy. When It Comes to Swine Flu, Your Pet Is Safe
Beware of Dog Bites
'Comfort Dogs' Come to Emotional Rescue
BONES & JOINTS
Most Kids With Type 1 Diabetes Lack Vitamin D
Tips to Ease an Aching Back
Drinking Cuts Rheumatoid Arthritis Risk
CANCER
Sharing Cancer Info May Be Empowering
Mineral May Reduce High-Risk Bladder Disease
Vitamin D May Lower Colon Cancer Risk
CAREGIVING
Hospital Practices Influence Which Moms Will Breast-Feed
Distance No Bar to Kidney Transplants in Remote Areas
UV Lights, Fans May Curb TB Spread in Hospitals
CIRCULATORY SYSTEM
Bad Marriages Harder on Women's Health
Obesity Linked to Heart Failure Risk
Drink a Little Wine, Live a Little Longer
COSMETIC
Get Sugared!.... Its a sweet choice for hair removal
Wrinkle Fillers Need Better Label Warnings: FDA Panel
With Psoriasis, the Internet May Offer Hope
DENTAL, ORAL
Hormones May Be to Blame for Women's Cavity Rates
Good Oral Hygiene May Protect Against Heart Infections
Obesity Boosts Gum Disease Risk
DIABETES
Saliva Test Could Monitor Type 2 Diabetes
Insulin Resistance Tied to Peripheral Artery Disease
'Standard' Glucose Test May Be Wrong One for Obese Children
DIET, NUTRITION
Lose Weight, Sleep Apnea May Improve
To Feel Better, Low-Fat Diet May Be Best
Six Healthy-Sounding Foods That Really Aren't
DISABILITIES
Could Your Cell Phone Help Shield You From Alzheimer's?
Review Finds Marijuana May Help MS Patients
ENVIRONMENTAL HEALTH
Chemical in Plastics May Cause Fertility Problems
EPA Alerts Seniors to Carbon Monoxide Dangers
Climate Change Could Sting Allergy, Asthma Sufferers
EYE CARE, VISION
Retinal Gene Is Linked to Childhood Blindness
Autistic Children Make Limited Eye Contact
High Temps Degrade Contact Lens Solution: Study
FITNESS
Research Confirms How Valuable A Healthy Lifestyle Can Be
FDA Mandates New Warnings for Botox
Tai Chi and Qigong Offer Many Health Benefits: Review
GASTROINTESTINAL PROBLEMS
Japanese Herbals May Ease Gastro Woes
Peppermint Oil, Fiber Can Fight Irritable Bowel
Bowel Prep Harder on Women Than Men
GENERAL HEALTH
Want Sun Protection? Wear Red or Blue
Autumn Chores Often Hazardous
Vinegar Might Help Keep Off Pounds
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
Magnet Therapy May Ease Hard-to-Treat Depression
The Internet Is Becoming One-Stop Shopping for Health Help
HEARING
Noise Hurts Men's Hearing More, Study Shows
Summer Sounds Can Lead to Hearing Loss
HEART & CARDIOVASCULAR
After a Stroke, Light Exercise Gets Hands, Arms Working Again
Psychiatric Drugs Might Raise Cardiac Death Risk
Rheumatoid Arthritis a Threat to the Heart
INFECTIOUS DISEASE
Swine Flu Closes Three Schools in NYC
Swine Flu Loves a Crowd
Bacterial Infections May Succumb to Honey
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Exercise Helps Reduce Falls in Young and Old
Don't Leave Your Kids In The Car !
Teen Internet Addicts More Likely to Self-Harm: Study
MEN'S HEALTH
Low Vitamin D Levels May Boost Men's Heart Attack Risk
Strenuous Daily Workout May Keep Cancer at Bay
More Vitamin C May Mean Less Chance of Gout
MENTAL HEALTH
Environmental Chemicals May Affect Male Reproduction
Man's Best Friend Helps Mend Broken Hearts
Brain Scans Show How Humans 'Hear' Emotion
PAIN
'Cell Phone Elbow' -- A New Ill for the Wired Age
Alleviating Rheumatoid Arthritis
Are We Exercising Pain Away? Not So Much.
PHYSICAL THERAPY
PREGNANCY
Heart Defects in Newborns Linked to Antidepressants
Sugary Colas Tied to Gestational Diabetes
For Baby and Mom Alike, Breast-Feeding May Be Best
SENIORS
As You Age, Better Health Means Better Sex
For a Healthier Retirement, Work a Little
Tai Chi May Help Ward Off Knee Pain in Seniors
SEXUAL HEALTH
SLEEP DISORDERS
Lose Weight, Sleep Apnea May Improve
Exercising Throat Muscles May Relieve Sleep Apnea
Pay Attention to Signs That Say You're Too Fatigued to Drive
WOMEN'S HEALTH
Mom and Baby Alike May Benefit From Exercise
Alternative Treatments May Boost IVF Success
Varicose Veins May Mask Larger Problem
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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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