ALLERGY, RESPIRATORY
Know Your Asthma Triggers
New Spray Could Benefit Cystic Fibrosis Patients
Asthmatics Who Quit Smoking May Reverse Lung Damage
ALTERNATIVE MEDICINE
Pharoah's Wine Jar Yields Medicinal Secrets
Acupuncture Eases Side Effects of Head, Neck Cancer Treatments
Indigo Ointment Benefits Psoriasis Patients
ANIMAL CARE
Beware of Dog Bites
Rest Easy. When It Comes to Swine Flu, Your Pet Is Safe
Safe Toys for Dogs
BONES & JOINTS
Majority of College Students Report Backpack-Related Pain
Occupational Therapy Plus Exercise Benefits Osteoarthritis
Genes May Help Drive Rotator Cuff Injury
CANCER
Herb May Counter Liver Damage From Chemo
Meditation May Reduce Stress in Breast Cancer Patients
U.S. Reported 25,000 Cases of HPV-Related Cancers Annually
CAREGIVING
When the Caregiver Becomes the Patient
Depression, PTSD Common Among Lung Transplant Patient Caregivers
With Age Comes Greater Risk of Hypothermia
CIRCULATORY SYSTEM
Bye, Bye Back Fat?
Migraines in Pregnancy Boost Vascular Risks
Health Tip: Are You Anemic?
COSMETIC
New Genetic Links to Baldness Discovered
Get Sugared!.... Its a sweet choice for hair removal
The Acne Drug Accutane More Than Doubles Depression Risk
DENTAL, ORAL
Hormones May Be to Blame for Women's Cavity Rates
Study Links Osteoporosis Drugs to Jaw Trouble
Gum Disease Treatment Doesn't Cut Preterm Birth Risk
DIABETES
Patients' Photos Help Boost Radiologists' Accuracy
Boosting Vitamin D Can Do a Heart Good
Findings Challenge Tight Glucose Control for Critically Ill Patients
DIET, NUTRITION
The Best Diet? That Depends on You
Six Healthy-Sounding Foods That Really Aren't
Adults Need To Get Thier Food Facts Straight
DISABILITIES
Review Finds Marijuana May Help MS Patients
Could Your Cell Phone Help Shield You From Alzheimer's?
ENVIRONMENTAL HEALTH
Accumulated Lead May Affect Older Women's Brains
Ozone-Depleting Inhalers Being Phased Out
Air Pollution May Cause Appendicitis: Study Reveals
EYE CARE, VISION
Eye Problems, Hearing Loss May Be Linked
Impotence Drugs Don't Harm Vision: Study
Americans Losing Sight of Eye Health
FITNESS
Avoiding a Holiday Season of Discontent
Simple Steps Get Walkers Moving
Good Warm-Ups Could Halve Sports Injuries
GASTROINTESTINAL PROBLEMS
New Guidelines Issued for Management of IBS
New Yogurt May Ease Stomach Ulcers
Traditional Nonsurgical GERD Treatments Not Impressive
GENERAL HEALTH
Laugh and the World Understands
6 to 8 Hours of Shut-Eye Is Optimal for Health
Spot light on Dani Antman New Lionheart teacher
HEAD & NECK
Zen May Thicken Brain, Thwart Pain
Many Children Will Outgrow Headaches
Ski Helmets Encouraged for All
HEALTH & TECHNOLOGY
E-Mailing Your Way to Healthier Habits
Combating Myths About Seasonal Allergies
Airport Full Body Scanners Pose No Health Threat: Experts
HEARING
Summer Sounds Can Lead to Hearing Loss
Noise Hurts Men's Hearing More, Study Shows
HEART & CARDIOVASCULAR
Exercise May Blunt Salt's Effect on Hypertension
Omega-6 Fatty Acids Can Be Good for You
Toothbrushing May Stave Off Heart Woes
INFECTIOUS DISEASE
Surgical Masks Could Prevent Flu, Maybe
Chinese 'Devil Dung' Plant Could Be a Swine Flu Fighter
Older Adults May Have Some Immunity to Swine Flu
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Older People at Greater Risk of Swine Flu Death
Eating Fish, Breast-Feeding Boost Infant Development
Should Your Child Be Seeing a Chiropractor?
MEN'S HEALTH
Sunlight May Help Protect Men From Kidney Cancer
Varicose Veins May Mask Larger Problem
Drinking Green Tea May Slow Prostate Cancer
MENTAL HEALTH
The 3LS Wellness Program for Reversing Chronic Symptoms and Creating Lasting Health
Teen Internet Addicts More Likely to Self-Harm: Study
Daily dose of beet juice promotes brain health in older adults
PAIN
Are We Exercising Pain Away? Not So Much.
Tai Chi May Help Ease Fibromyalgia
'Cell Phone Elbow' -- A New Ill for the Wired Age
PHYSICAL THERAPY
PREGNANCY
Obesity May Affect Fertility in Young Womene
Sugary Colas Tied to Gestational Diabetes
Acupuncture May Relieve Acid Indigestation In Pregnancy
SENIORS
Common Antioxidant Might Slow Parkinson's
Memory Loss Help from Brain Supplement Prevagen
As You Age, Better Health Means Better Sex
SEXUAL HEALTH
SLEEP DISORDERS
Meditation May Help Put Primary Insomnia to Bed
Pay Attention to Signs That Say You're Too Fatigued to Drive
6 to 8 Hours of Shut-Eye Is Optimal for Health
WOMEN'S HEALTH
Being Active an Hour a Day Puts Brakes on Weight Gain
Vitamin D Deficiency Puts 40% of U.S. Infants and Toddlers At Risk
Flame-Retardant Chemical Linked to Conception Problems
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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