ALLERGY, RESPIRATORY
Overweight Moms More Likely to Have Asthmatic Kids
Traffic, Dust Linked to Asthma in Kids
Obesity May Raise Kids' Allergy Risk
ALTERNATIVE MEDICINE
Imaging Sheds Light on How Acupuncture Works
Animals Respond to Acupuncture's Healing Touch
Acupuncture May Not Help Hot Flashes
ANIMAL CARE
Animals Respond to Acupuncture's Healing Touch
Safe Toys for Dogs
Rest Easy. When It Comes to Swine Flu, Your Pet Is Safe
BONES & JOINTS
Childhood Dairy Intake Boosts Bone Health Later On
Study Shows Exercise Shields Against Osteoporosis
Living Near Major Road May Boost Rheumatoid Arthritis Risk
CANCER
Ginger Can Ease Nausea From Chemotherapy Treatments
Where You Live May Affect Your Cancer Diagnosis
HPV Vaccine Has Higher Allergic Reaction Rate
CAREGIVING
3 Steps Might Help Stop MRSA's Spread
Stressed Health Care Workers Battle 'Compassion Fatigue'
Birthmark or Blood Vessel Problem?
CIRCULATORY SYSTEM
Laughter Can Boost Heart Health
Smog Tougher on the Obese
High Blood Fat Levels Common in Americans
COSMETIC
What to Do If You Have Unsightly Veins
Gum Chewing May Cut Craving for Snacks
Get Sugared!.... Its a sweet choice for hair removal
DENTAL, ORAL
Most Insured Adults Worry About Health Care Costs: Poll
Gummy Bears Join Cavity Fight
Scientists Find Gene for Tooth Enamel
DIABETES
Arthritis Hits More Than Half of Diabetics
Americans Consuming More Sugary Beverages
Brown Rice Bests White for Diabetes Prevention
DIET, NUTRITION
Fruit Even Healthier Than Thought: Study Shows
Teens Lose More Weight Using Healthy Strategies
Adults Need To Get Thier Food Facts Straight
DISABILITIES
Could Your Cell Phone Help Shield You From Alzheimer's?
Review Finds Marijuana May Help MS Patients
ENVIRONMENTAL HEALTH
Gas Stove Emissions Boost Asthma in Inner-City Kids
Golf Course Insecticides Pose Little Danger to Players
Fish in U.S. Rivers Tainted With Common Medications
EYE CARE, VISION
Just Like Skin, Eyes Can 'Burn' in Strong Sun
Thyroid Problems Boost Glaucoma Risk
Statin Drugs Cause Eye Disorders
FITNESS
Avoiding a Holiday Season of Discontent
Exercise 30 Minutes a Day? Who Knew!
Occupational Therapy Plus Exercise Benefits Osteoarthritis
GASTROINTESTINAL PROBLEMS
Soothing Imagery May Help Rid Some Kids of Stomach Pain
HRT Use Raises Risk of Stomach Trouble
Bowel Prep Harder on Women Than Men
GENERAL HEALTH
Workplace Wellness Seems to Really Work
After Job Loss, People Report More Health Issues
When Clocks Change, Body May Need Time to Adjust
HEAD & NECK
Zen May Thicken Brain, Thwart Pain
Many Children Will Outgrow Headaches
Ski Helmets Encouraged for All
HEALTH & TECHNOLOGY
'Comfort Dogs' Come to Emotional Rescue
Using Light Therapy to Silence Harmful Brain Activity
Study Suggests Link Between Cell Phones and Brain Tumors
HEARING
Noise Hurts Men's Hearing More, Study Shows
Summer Sounds Can Lead to Hearing Loss
HEART & CARDIOVASCULAR
Toothbrushing May Stave Off Heart Woes
Potassium-Rich Foods May Cut Stroke, Heart Disease Risk
Implanted Defibrillators Boost Long-Term Survival
INFECTIOUS DISEASE
The HPV Vaccine: Preventative Medicine or Human Sacrifice?
Swine Flu Is Now a Pandemic Says W.H.O.
Older Adults May Have Some Immunity to Swine Flu
INFERTILITY
Obesity May Affect Fertility in Young Womene
KID'S HEALTH
Many Children Will Outgrow Headaches
Winter's Bitter Cold Poses Health Dangers
Babies Who Eat Fish Lower Eczema Risk
MEN'S HEALTH
The Dark Side of Vegetarianism
Exercise May Prevent Prostate Cancer: Study Shows
Physical Activity May Prolong Survival After Colon Cancer
MENTAL HEALTH
Breast-Fed Baby May Mean Better Behaved Child
Man's Best Friend Helps Mend Broken Hearts
Chocolate a Sweet Pick-Me-Up for the Depressed
PAIN
'Cell Phone Elbow' -- A New Ill for the Wired Age
Tai Chi May Help Ease Fibromyalgia
Alleviating Rheumatoid Arthritis
PHYSICAL THERAPY
PREGNANCY
Sleeping Could Help Women Lose The Baby Fat
Calcium Supplements Cut Blood Lead Levels During Pregnancy
Expectant Mom's Exercise Keeps Newborn's Birth Weight Down
SENIORS
For Older Walkers, Faster Is Better
Tai Chi May Help Ease Fibromyalgia
The Juice From Beetroots May Boost Stamina
SEXUAL HEALTH
SLEEP DISORDERS
Better Sleep, Grades Seem to Go Up
Sleeping Could Help Women Lose The Baby Fat
Meditation May Help Put Primary Insomnia to Bed
WOMEN'S HEALTH
Broccoli May Help Battle Breast Cancer
Simple Carbs Pose Heart Risk for Women
Acupuncture May Relieve Acid Indigestation In Pregnancy
Add your Article

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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