ALLERGY, RESPIRATORY
New Spray Could Benefit Cystic Fibrosis Patients
Childhood Food Allergies on the Rise
Folic Acid Might Offer Allergy Relief
ALTERNATIVE MEDICINE
Awareness of Alternative Therapies May Be Lacking
Naprapathy: A Hands-On Approach to Pain Management
Maggots as Good as Gel in Leg Ulcer Treatments
ANIMAL CARE
'Comfort Dogs' Come to Emotional Rescue
Separation Anxiety, Canine-Style
Animals Respond to Acupuncture's Healing Touch
BONES & JOINTS
Vitamin D Plus Calcium Guards Against Fractures
Fall Sports Peak Time for Lower Leg Damage
Active Young Women Need Calcium, Vitamin D
CANCER
Spice Compounds May Stem Tumor Growth
Study Cites Gains in Gall Bladder Cancer Treatment
Papaya Could Be a Cancer Fighter
CAREGIVING
Many Alzheimer's Caregivers Admit to Abusive Behavior
Study of Everest Climbers Questions Oxygen Use
Many Hospital Patients Can't ID Their Doctors
CIRCULATORY SYSTEM
Firefighters Have Narrower-Than-Normal Arteries, Study Finds
Drink a Little Wine, Live a Little Longer
Review Confirms Links Between Diet, Heart Health
COSMETIC
Gum Chewing May Cut Craving for Snacks
Wrinkle Fillers Need Better Label Warnings: FDA Panel
Contact Lenses Boost Kids' Self-Image
DENTAL, ORAL
Good Oral Hygiene May Protect Against Heart Infections
Hormones May Be to Blame for Women's Cavity Rates
Mom's Vitamin D Levels Affect Baby's Dental Health
DIABETES
Whole Grains Take a Bite Out of Type 2 Diabetes Risk
Americans Consuming More Sugary Beverages
Drug May Not Help Diabetes-Related Eye Damage
DIET, NUTRITION
Asparagus May Ease Hangover
More Calcium And Dairy Products in Childhood Could Mean Longer Life
Want to Stop Cancer? You Can, Experts Say
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
Short-Term Air Pollution Exposure May Damage DNA
Accumulated Lead May Affect Older Women's Brains
EYE CARE, VISION
Brain Adapts to Age-Related Eye Disease
It's a Whole New Outlook for Cataract Patients
Nutrient-Rich Diet Lowers Risk of Age-Related Eye Disease
FITNESS
Simple Steps Get Walkers Moving
Super Bowl Loss Can 'Kill' Some Fans
Be Healthy, Spend Less
GASTROINTESTINAL PROBLEMS
Intestinal Bacteria Trigger Immune Response
HRT Use Raises Risk of Stomach Trouble
Olive Oil May Protect Against Bowel Disease
GENERAL HEALTH
A Little Alcohol May Stave Off Alzheimer's
Trans-Fat Ban In New York City Is Proving successful
Smog Tougher on the Obese
HEAD & NECK
Many Children Will Outgrow Headaches
Ski Helmets Encouraged for All
Zen May Thicken Brain, Thwart Pain
HEALTH & TECHNOLOGY
Subway Defibrillators Save Lives
'Cell Phone Elbow' -- A New Ill for the Wired Age
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
Rheumatoid Arthritis a Threat to the Heart
Boosting Vitamin D Can Do a Heart Good
Western Diet Linked To Heart Disease, Metabolic Syndrome
INFECTIOUS DISEASE
Chinese 'Devil Dung' Plant Could Be a Swine Flu Fighter
Swine Flu Is Now a Pandemic Says W.H.O.
Poor Restroom Cleaning Causes Cruise-Ship Sickness
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Eating Fish, Breast-Feeding Boost Infant Development
Even Young Kids Can Learn CPR
Better Sleep, Grades Seem to Go Up
MEN'S HEALTH
The Dark Side of Vegetarianism
Low Iron Levels Cut Cancer Risk in Men With PAD
Varicose Veins May Mask Larger Problem
MENTAL HEALTH
A Simple 'Thank You' Brings Rewards to All
The Acne Drug Accutane More Than Doubles Depression Risk
Optimism May Boost Immune System
PAIN
Alleviating Rheumatoid Arthritis
Tai Chi May Help Ease Fibromyalgia
Are We Exercising Pain Away? Not So Much.
PHYSICAL THERAPY
PREGNANCY
Alternative Treatments May Boost IVF Success
Calcium Supplements Cut Blood Lead Levels During Pregnancy
Exercise Boosts Bone Density in Breast-Feeding Moms
SENIORS
Community Exercise Programs Boost Seniors' Strength
Common Antioxidant Might Slow Parkinson's
Vitamin D May Help Keep Aging at Bay
SEXUAL HEALTH
SLEEP DISORDERS
6 to 8 Hours of Shut-Eye Is Optimal for Health
Better Sleep, Grades Seem to Go Up
Exercising Throat Muscles May Relieve Sleep Apnea
WOMEN'S HEALTH
A Brisk Pace May Keep Stroke at Bay
Supplements Might Reduce Breast Cancer Risk
Occaisonal Dieting May Cut Breast Cancer, Study Says
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FDA Mandates New Warnings for Botox

By Amanda Gardner
HealthDay Reporter

THURSDAY, April 30 (HealthDay News) -- Reports of deaths among people using popular anti-wrinkle injections such as Botox to treat muscle spasms have prompted a change in labeling.

Botox and similar products will now be required to carry boxed warnings, the most serious type of label warning, the U.S. Food and Drug Administration announced Thursday.

Most cases involved children given the drug to control muscle spasticity associated with cerebral palsy and adults using it to treat muscle spasticity, migraines and cervical dystonia.

"The hospitalizations are very few, deaths are very rare, but they have been reported," said Dr. Ellis F. Unger, acting deputy director of the FDA's Office of Drug Evaluation, said during a teleconference.

"We don't want to discourage use of these drugs as patients taking them have significant disability and the drugs are effective to relieve important problems," he said. "But people just need to understand the risks that are involved so they can make informed, risk-benefit decisions."

Other side effects include muscle weakness, difficulty breathing, loss of bladder control and pneumonia. Some people have required feeding tubes.

Unger said the deaths have not been clearly attributable to injection of the drugs, as everyone who died also suffered from other conditions.

None of the cases so far reported have been associated with use of botulinum products in cosmetic or dermatological procedures, such as clearing furrows between the eyebrows, according to the FDA. Botulinum toxins are not approved by the FDA to treat severe arm and leg muscle spasms, although they are approved for dermatological indications as well as cervical dystonia.

Officials believe that most of the problems occurred when one product was substituted for another without corresponding dose adjustments.

"There are now three products approved in the U.S., each with different units, and the units cannot be interchanged," Unger said. "Switching patients from one to another runs the risk of underdosing or, more important, overdosing."

The three approved products are Botox, Myobloc and Dysport, which was approved this week. Officials said there have been no post-marketing reports of similar problems with the newest drug.

The injections, which temporarily "paralyze" muscles, are intended to have a localized effect but can pose problems if the compound spreads to other parts of the body.

"When given in a particular place, they spread locally, meaning they move into adjacent structures," Unger explained. "We have known that for years, and it can be annoying and somewhat of a significant problem for given patients but does not result in disability or harm."

"The real concern is when there is distant spread," he said. "It is injected at one point and spreads to areas not adjacent."

The FDA issued an "early communication" in February 2008, warning of these adverse reactions. The month before, the watchdog group Public Citizen petitioned the agency to add a black-box warning to the two drugs then on the market in the United States, describing 180 "adverse event cases" related to the drugs, including 16 deaths, four in people younger than 18.

Between early 2008 and now, the FDA became "more certain about the cases," Unger said. "We felt we really needed to nail down the scope of the problem before we placed a boxed warning, which is something we take very seriously."

The FDA will also require manufacturers to put in place what it calls a risk evaluation and mitigation strategy -- in essence, a comprehensive patient safety guide.

"Updating labeling will help patients and health-care professionals better understand the risks and benefits," Unger said. "These drugs have benefits, but they also can cause serious problems."

More information

The American Academy of Dermatology has more on botulinum toxin products.



SOURCE: April 30, 2009, teleconference with Ellis F. Unger, M.D., acting deputy director, Office of Drug Evaluation I, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Last Updated: April 30, 2009

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