 Issue
#2 - Winter 2004
 Don't
Let the Flu Catch You
If you haven't gotten a flu shot yet, it's not too late.
The flu vaccine is still the best way to prevent and control
flu and the sniffles, aches and fever that come with it.
Flu season in the United States runs from November to April.
October to November is the time when most people get vaccinated
for the flu. "But you can also get good results when
the vaccine is used in December and January, even if influenza
(flu) is already starting to spread through a community,"
says Roland A. Levandowski, M.D., a medical officer and virologist
in the Food and Drug Administration's Center for Biologics
Evaluation and Research.
The Flu Vaccine
Flu viruses are classified as types A, B, or C. Type A and
B viruses are the most serious because they are most often
responsible for cases of the flu and all of its complications.
Type C viruses are mostly associated with cold symptoms.
There are two types of flu vaccines. The injectable flu shot
contains killed viruses and is given in the arm with a needle.
The nasal spray flu vaccine contains weakened live viruses,
and is given by nasal sprayer. The injectable flu shot is
made by two manufacturers. One product is approved for use
in children over 6 months of age, as well for healthy people
and those with chronic medical conditions. The other is approved
for use in individuals at least four years and older. The
nasal spray flu vaccine is approved for use only in healthy
people between the ages of 5 and 49.
The protective effect of the vaccine starts working rapidly
in people who have previously been infected with flu viruses
or have gotten a flu shot in the past. Infection-fighting
antibodies in the blood are strongest about three weeks after
these people are vaccinated.
Injected flu vaccine is made of killed virus and can't cause
the flu. The most common side effect is soreness in the area
where the shot is given. Flu vaccines are not recommended
for certain people, including those allergic to eggs, because
the viruses for flu vaccines are grown in eggs.
Preventing the Flu
Both colds and flu can be passed through coughing, sneezing,
and touching surfaces such as doorknobs and telephones, so
it's wise to make a habit of washing your hands. This
helps prevent you from spreading infections and picking them
up from someone else.
The Centers for Disease Control and Prevention (CDC) recommends
regular scrubbing of your hands with warm, soapy water for
about 15 seconds. Touching your nose, mouth, and eyes with
contaminated hands makes it easy for cold and flu viruses
to enter the body. Others can become ill just by coming in
contact with someone who has been infected with a cold or
flu virus or who has come in contact with a contaminated area.
Eating a balanced diet, getting enough sleep, and exercising
can help the immune system fight off the germs that cause
illness. Because smoking interferes with the mechanisms that
keep bacteria and debris out of the lungs, those who use tobacco
or who are exposed to secondhand smoke are more prone to respiratory
illnesses and more severe complications than nonsmokers.
What if You Get the Flu
Your doctor has many methods of diagnosing the flu including
using an FDA approved rapid influenza diagnostic test that
can detect flu types A and B in about 30 minutes.
Children and teens suffering from flu-like symptoms, chickenpox
and other viral illnesses shouldn't take aspirin or products
containing aspirin because the pain reliever could mask symptoms
of Reye's syndrome. When buying over-the-counter medications
for use by children and teens look for aspirin-free products.
Some medicine labels may refer to aspirin as salicylate or
salicylic acid.
A person with Reye's syndrome will start vomiting and become
drowsy within a few days of becoming sick. Reye's syndrome
almost always occurs in children 4 to 12 years of age. Though
rare in adults, it can affect all body organs and lead to
brain damage and death.
An Alphabet
of Viruses
There are three types of flu
virus: A, B and C.
Types A and B are the most serious
because they change more quickly than a person's immune
system. The flu vaccine targets strains of type A and
B viruses because they cause the most damage and infect
the most number of people.
Type C is often mistaken for
a cold because the illness it causes can be mild or
even without symptom. |
| Symptoms for colds and flu can
be similar; both can cause a stuffy nose, sore throat,
cough, and fever and generally last about a week or two.
Colds are usually marked
by a runny nose and sneezing. The flu is more serious
than a cold, lasts longer, and often leaves you with
a wiped-out feeling, a headache, chills, dry cough,
and body aches. |
Back to Table of Contents
 Focus
on: Reye's Syndrome (RS)
What is Reye's Syndrome: RS is a disease that
affects all organs of the body, especially the brain and liver.
It causes an increase of pressure within the brain and can
cause accumulations of fat in the liver and other organs.
The disorder commonly occurs during recovery from a viral
infection, such as flu or the chicken pox.
Symptoms: Persistent or recurrent vomiting,
listlessness, personality changes such as irritability or
combativeness, disorientation or confusion, delirium, convulsions,
and loss of consciousness.
Who Gets it: Reye's syndrome (RS) is primarily
a children's disease, although it can occur at any age.
Prevention: The cause of RS remains a mystery.
However, studies have shown that using aspirin or salicylate-containing
medications to treat viral illnesses increases the risk of
developing RS.
Treatment: There is no cure for RS. Successful
management, which depends on early diagnosis, is primarily
aimed at protecting the brain against irreversible damage
by reducing brain swelling, reversing the metabolic injury,
preventing complications in the lungs, and anticipating cardiac
arrest.
What to do if you think you have RS: If symptoms
of RS are present during or soon after a viral illness, such
as flu, call your doctor immediately.
For more information visit:
http://www.ninds.nih.gov/health_and_medical/disorders/reyes_syndrome.htm
http://www.reyessyndrome.org
Back to Table of Contents
 Flu
Vaccines: More Option Mean Better Protection
The FDA recently approved FluMist, the first nasal flu vaccine
to treat A and B flu viruses in people 5-49 years old.
Like the injected flu vaccine, each FluMist dose contains
the three flu strains recommended for the 2003-2004 season.
The strains of live virus are modified so they don't grow
efficiently at body temperature, but replicate enough to produce
immunity.
FluMist should not be given to people who:
- have immune suppression or take drugs that cause immunosuppression,
- have immune deficiency diseases (AIDS or cancer),
- have asthma or other reactive airway diseases,
- are 50 years old and over,
- have chronic medical conditions that may predispose them
to severe flu infections, or
- have had an allergic reaction to eggs or a previous dose
of the vaccine.
Tips
on Caring For the Flu
Drink plenty of fluids
Fluids such as water, juice, soup, and non-caffeinated
beverages can help loosen mucus, keep you hydrated,
and make you feel better, especially if you have a fever.
Avoid alcohol and drinks with caffeine
Drinks containing alcohol and caffeine can have a dehydrating
effect.
Throw out used tissues
Limit your exposure to used tissues and the bacteria
they hold by disposing of them quickly.
Gargle salt water
Salt water can help relieve a sore throat.
Use a cool-mist humidifier
A cool-mist humidifier breaks water into droplets and
releases them into the air, which may help relieve a
stuffy nose.
Choose the correct over-the-counter medicines
Chose medicines that treat only the symptoms you have
and avoid over-medicating.
Use only aspirin-free medicines in children and
teens
Children and teens suffering from flu-like symptoms
should avoid taking aspirin because it can mask the
symptoms of Reye's syndrome, a potentially fatal illness. |
Take the Flu Quiz…
Test your flu vaccine savvy with these true or false questions,
then check your answers below.
True or False?
Q1: People can die
from the flu.
Q2: Even if I get the
flu vaccine, I can still get a mild case of the flu.
Q3: The side effects
of the flu vaccine are worse than the flu
Q4: Not everyone can
take the flu vaccine.
Q5: Only older people
need flu vaccine.
Q6: You must get the
flu vaccine before December.
Back to Table of Contents
 Misuse
of Prescription Pain Relievers:
Think Twice-Because You Only Die Once
Prescription pain relievers, when used correctly and under
a doctor's supervision, are safe and effective. But abuse
them, or mix them with illegal drugs or alcohol, and the user
could wind up in the morgue.
Even using prescription pain relievers with other prescription
drugs (such as antidepressants) or over-the-counter medications
(like cough syrups and antihistamines), can lead to life-threatening
respiratory failure. That's why people can drop pills at parties,
and then drop dead. They're not downing handfuls of pills,
either. With some prescription pain relievers, all it takes
is one pill.
Drugs to watch out for.
The most dangerous prescription pain relievers are those
containing drugs known as opioids, such as morphine and codeine.
Some common drugs containing these substances include Darvon,
Demerol, Dilaudid, OxyContin, Tylenol with Codeine, and Vicodin.
These drugs have many street names: ac/dc, coties, demmies,
dillies, hillbilly heroin, o.c., oxy, oxycotton, percs and
vics to name a few.
Symptoms of overdose.
Here are the danger signs to watch for:
- Slow breathing (less than ten breaths a minute is always
serious)
- Small, pinpoint pupils
- Confusion
- Being tired, nodding off, or passing out
- Dizziness
- Weakness
- Apathy (they don't care about anything)
- Cold and clammy skin
- Nausea
- Vomiting
- Seizures
Many of these symptoms can make people think a person is
drunk. They may be tempted to let a person sleep it off, or
tell others that they had too much to drink. That's a bad
idea. A person who overdoses could go to sleep and never wake
up.
What to do if someone is overdosing.
- Make an anonymous call to 911 or to the person's parents
if you're too scared to identify yourself.
- Try to get the person to respond by calling out his/her
name.
- Make the person wake up and talk.
- Shake them if necessary. Otherwise, they could suffer
brain damage, fall into a coma, or die.
Addiction can be a living death.
If a person abuses prescription pain relievers and is lucky
enough to cheat death, they're still in big trouble. Prescription
pain relievers can be addictive. The longer a person takes
them, the more their body needs. Try to stop, and they could
experience withdrawal symptoms.
Addiction to prescription pain relievers is like being hooked
on heroin and the withdrawal isn't much different. Addicts
in withdrawal can suffer agonizing muscle pain, diarrhea,
vomiting, cold flashes and insomnia.
If you, or someone you know, is abusing or is addicted, get
professional help. You can also ask for help from parents,
doctors, relatives, teachers, or school guidance counselors.
Substance abuse ruins lives. Don't let it happen to your friends
-- or you.
If you, or someone you know, is hooked on prescription pain
relievers, call the substance abuse treatment 24-hour helpline:
Back to Table of Contents
 Antibiotics:
A Misused Miracle?
When antibiotics first arrived on the market more than 50
years ago, they were hailed as miracle drugs; misused as disease
and bacteria-killing cure-alls that patients relied on to
treat everything from the common cold to an ear infection.
But with each passing decade, bacteria that resist not only
single, but multiple, antibiotics--making some diseases particularly
hard to control--have become increasingly widespread. In fact,
according to the Centers for Disease Control and Prevention
(CDC), many significant types of bacteria that cause infections
are becoming more resistant to commonly prescribed antibiotics.
For some of us, bacterial resistance could mean more visits
to the doctor, a lengthier illness, and possibly more toxic
drugs. For others, it could mean death. The CDC estimates
that each year, nearly 2 million people in the U.S. get an
infection while in a hospital, resulting in 90,000 deaths.
More than 70 percent of the bacteria that cause these infections
are resistant to at least one of the antibiotics commonly
used to treat them.
"Antibacterial resistance is a serious and growing public
health problem in the U.S. and worldwide," says FDA Commissioner,
Mark McClellan, M.D., Ph.D. "Without effective antibiotic
drugs, common infections, that were once easily treated, can
create a serious health threat to children and adults alike."
Many bacterial species, including the species that cause
pneumonia and other respiratory tract infections, meningitis,
and sexually transmitted diseases, are becoming increasingly
resistant to the antibacterial drugs used to treat them. Several
bacterial species have developed strains that are resistant
to every approved antibiotic.
Yet, antibacterial resistance, also known as, antimicrobial
or antibiotic resistance, is not a new phenomenon. Just a
few years after the first antibiotic, penicillin, became widely
used in the late 1940s, penicillin-resistant infections emerged
that were caused by the bacterium Staphylococcus aureus
(S. aureus). These "staph" infections range
from urinary tract infections to bacterial pneumonia.
Preserving Antibiotics' Usefulness
In 1999, 10 federal agencies and departments, led by the
Department of Health and Human Services, formed a task force
to tackle the problem of antimicrobial resistance. The success
of the plan--known as the Public Health Action Plan to Combat
Antimicrobial Resistance--depends on the cooperation of many
groups, such as state and local health agencies, universities,
professional societies, pharmaceutical companies, health-care
professionals, agricultural producers, and the public.
Two main types of germs--bacteria and viruses--cause most
infections, according to the CDC. But while antibiotics can
kill bacteria, they do not work against viruses--and it is
viruses that cause colds, the flu, and most sore throats.
In fact, only 15 percent of sore throats are caused by the
bacterium Streptococcus, which also causes strep throat.
In addition, it is viruses that cause most sinus infections,
coughs, and bronchitis. And fluid in the middle ear, a common
occurrence in children, does not usually need treatment with
antibiotics unless there are other symptoms.
Antibiotics do not prevent or treat influenza (flu) which
is also caused by a virus. FDA has approved several prescription
anti-influenza antiviral drugs for the prevention and treatment
of influenza.
To decrease both demand and over-prescribing, the FDA and
the CDC have launched antibiotic resistance campaigns aimed
at health-care professionals and the public. A nationwide
ad campaign developed by the FDA's Center for Drug Evaluation
and Research encourages health-care professionals to use antibiotics
cautiously, and offers them an educational brochure to distribute
to patients (http://www.fda.gov/cder/consumerinfo/antibiot-resist-brochure.pdf
or http://www.fda.gov/cder/consumerinfo/antibiot-resist-brochure.htm.)
The FDA published a final rule in February 2003 that requires
specific language on antibiotics labeled for human use to
encourage doctors to prescribe them only when truly necessary.
The rule also requires a statement in the labeling asking
doctors to counsel their patients about the proper use of
these drugs.
To find out more about antibiotic resistance, see the FDA's
Web site at http://www.fda.gov/oc/opacom/hottopics/anti_resist.html,
and the CDC's Web
site at http://www.cdc.gov/drugresistance/.
| Will Antibiotics
Treat Your Illness?
Most upper respiratory infections are usually caused
by
viruses -- germs that cannot be killed by antibiotics. |
| Illness |
Antibiotic Needed? |
| Cold |
No |
| Flu |
No |
Chest Cold
(in otherwise healthy children and adults)
|
No |
Sore Throats
(except strep) |
No |
Bronchitis
(in otherwise healthy children and adults) |
No |
Runny Nose
(with green or yellow mucus) |
No |
Fluid in the Middle Ear
(otitis media with effusion) |
No |
How Bacteria
Become Resistant
Bacteria are organisms so small that they are invisible
to the naked eye. They live all around us-in drinking
water, food, soil, plants, animals-- and in us.
Most bacteria are not harmful. Some are even useful
because they can help our bodies function such as in
digesting food. But many bacteria are capable of causing
severe infections.
The ability of antibiotics to stop an infection depends
on killing or halting the growth of harmful bacteria.
But some bacteria resist the effects of drugs and multiply
and spread.
Some bacteria have developed resistance to antibiotics
naturally, long before the development of commercial
antibiotics.
After testing bacteria found in an arctic glacier and
estimated to be over 2,000 years old, scientists found
several of them to be resistant to antibiotics. This
evidence most likely indicates a naturally occurring
resistance.
If they are not naturally resistant, bacteria can become
resistant to drugs. The more you use antibiotics, the
more likely bacteria are to become resistant to the
antibiotics. For instance, they may develop resistance
to certain drugs spontaneously through mutation. Mutations
are changes that occur in the genetic material, or DNA,
of the bacteria. These changes allow the bacteria to
fight or inactivate the antibiotic. Using antibiotics
may kill normal bacteria, but the mutated versions can
still live and multiply. |
Back to Table of Contents
 Trans
Fats:
The Truth May Be Hard to Swallow
Everyone should be aware of the risks posed by consuming
too much saturated fat, trans fat, and cholesterol.
Scientific evidence shows that eating saturated fat, trans
fat (trans fatty acid), and dietary cholesterol raises
low-density lipoprotein (LDL), or "bad" cholesterol
levels, and increases the risk of coronary heart disease (CHD).
According to the National Heart, Lung, and Blood Institute
of the National Institutes of Health, more than 12.5 million
Americans have CHD, and more than 500,000 die each year. That
makes CHD one of the leading causes of death in the US.
In 1993 FDA began requiring that saturated fat and dietary
cholesterol be listed on food labels. With trans
fat added to the Nutrition Facts panel, consumers now know
how much of all three-- saturated fat, trans fat,
and cholesterol--are in the foods they eat.
Identifying saturated fat, trans fat, and cholesterol
on the food label gives you information you need to make healthy
food choices. But what is trans fat, and how can
you limit the amount of this fat in your diet?
| What is Trans Fat?
Basically, trans fat is made when manufacturers
add hydrogen to vegetable oil--a process called hydrogenation.
Hydrogenation increases the shelf life and flavor stability
of foods containing these fats.
Trans fat can be found in vegetable shortening,
some margarines, crackers, cookies, snack foods, and
other foods made with, or fried in, partially hydrogenated
oils. Unlike other fats, the majority of trans
fat is formed when food manufacturers turn liquid oils
into solid fats like shortening and hard margarine.
A small amount of trans fat is found naturally
in dairy products, some meat, and other animal-based
foods.
Are All Fats the Same?
Simply put: No. Fat is a major source of energy for
the body and aids in the absorption of vitamins A, D,
E, and K, and carotenoids. Both animal and plant based
foods contain fat. When eaten in moderation, fat is
important for proper growth, development, and maintenance
of good health. |
| How
Do Your Choices Stack Up?
The following table illustrates
total fat, saturated fat and trans fat
content per serving for selected food products. |
| Product |
Common Serving Size |
Total Fat g |
Sat. Fat g |
Trans Fat
g |
French Fries*
(Fast Food) |
Medium
(147 g) |
27 |
7 |
8 |
| Potato Chips* |
Small Bag (42.5 g) |
11 |
2 |
3 |
| Doughnut* |
1 |
18 |
4.5 |
5 |
| Cookies* (Cream Filled) |
3 (30 g) |
6 |
1 |
2 |
| Candy Bar* |
1 (40 g) |
10 |
4 |
3 |
| * 1995 USDA Composition
Data. |
|
As a food ingredient, fat provides taste, texture, and stability
and helps you feel full. Fats are an especially important
source of calories and nutrients for infants and toddlers
(up to 2 years of age), who have the highest energy needs
per unit of body weight of any age group.
Saturated and trans fats raise LDL (or "bad")
cholesterol levels in the blood, thereby increasing the risk
of heart disease. Dietary cholesterol also contributes to
heart disease. Unsaturated fats, such as monounsaturated and
polyunsaturated, do not raise LDL cholesterol and are beneficial
when consumed in moderation. Therefore, it is wise to choose
foods low in saturated fat, trans fat, and cholesterol
as part of a healthful diet.
How Can You Choose Your Fats Wisely?
When comparing foods, look at the Nutrition Facts panel,
and choose the food with the lower amounts of saturated fat,
trans fat, and cholesterol. Health experts recommend
that you keep your intake of saturated fat, trans
fat, and cholesterol as low as possible while maintaining
a nutritional diet. However, these experts recognize that
eliminating these three components entirely from your diet
is not practical because they are unavoidable in ordinary
diets.
| Decoding
Fats
The chart below outlines the
main types of fats and the products they are commonly
found in. |
| Type of Fat |
Source |
Food Examples |
Trans fats
(aka trans fatty acids)
|
Hydrogenated oils found in commercially
processed foods and foods prepared with hydrogenated
oils |
- Cookies
- French fries
- Stick margarine
- Vegetable
shortening |
| Saturated |
Found mostly in animal and some
plant-derived products |
- Fatty meat
- Dairy products
- Coconut and
Palm oil
|
Unsaturated
-Monounsaturated
-Polyunsaturated
|
Plant products and fish |
- Olive and canola
oils
- Soybeans and
corn oils
- Peanuts
- Sunflower seeds |
|
Where Can You Find Trans
Fat on the Food Label?
Although some food products already have trans
fat on the label, food manufacturers have until January
2006 to list it on all their products.
You will find trans fat listed on the Nutrition
Facts panel directly under the line for saturated fat.
As a general rule, don't assume similar products are
the same. Be sure to check the Nutrition Facts panel
because even similar foods can vary in calories, ingredients,
nutrients, and the size and number of servings in a
package.
For more information on trans fats visit:
http://www.cfsan.fda.gov/~dms/transfat.html
|
Cutting
the Fat: Nutrition Tips
Here are some practical tips you can use to keep your
consumption of saturated fat, trans fat, and
cholesterol low.
- Choose foods lower in saturated fat, trans
fat, and cholesterol.
- Choose alternative fats. Replace saturated and trans
fats in your diet with monounsaturated and polyunsaturated
fats.
- Choose vegetable oils (except coconut and palm kernel
oils) and soft margarines (liquid, tub, or spray).
- Consider fish. Most fish are lower in saturated
fat than meat.
- When eating out, ask which fats are being used in
your food.
- Watch calories. Fat is high in calories. All sources
of fat contain 9 calories per gram. By comparison,
carbohydrates and protein have only 4 calories per
gram.
|
Back to Table of Contents
Flu Quiz: Answers
A1: True
Flu is a highly infectious disease of the lungs, and it can
lead to pneumonia. Each year about 114,000 people in the U.S.
are hospitalized and about 36,000 people die because of the
flu.
A2: True
Flu vaccine protects most people from the flu. People who
receive flu vaccine can get the flu but will be far less sick
than someone who has flu and has not received flu vaccine.
Flu vaccine does not protect you from other viruses that sometimes
feel like the flu.
A3: False
The worst side effect you are likely to get with injectable
vaccine is a sore arm. The nasal-spray flu vaccine might cause
nasal congestion, runny nose, sore throat or cough.
A4: True
You might not be able to get this protection if you are allergic
to eggs, are very sick with a high fever, or have had a severe
reaction to the flu vaccine in the past.
A5: False
Adults and children with conditions like asthma, diabetes,
heart disease, and kidney disease need to get flu vaccine.
People who are active and healthy can also benefit from the
protection of the flu vaccine offers.
A6: False
Flu vaccine can be given before or during the flu season.
While the best time to get flu vaccine is October or November,
getting vaccinated in December or later can still protect
you against the flu.
 Silicone
Implants Get Bounced
After careful consideration and weighing expert and public
opinion FDA has decided not to approve the use of silicone
breast implants, leaving saline implants the only widely available
option.
Instead, FDA has released a new guidance document for breast
implants that will help doctors, implant manufacturers and
the public evaluate breast implant safety and effectiveness
(http://www.fda.gov/cdrh/ode/guidance/1239.html).
The FDA recommends that patients considering implantation
carefully assess the risks and benefits with their doctor.
For reasons of safety, FDA discourages the use of any breast
implant in a patient younger than 18.
For more information on breast implants visit, http://www.fda.gov/cdrh/breastimplants/
and http://www.fda.gov/cdrh/bicl
Back to Table of Contents
Calendar
of National Health Events
- February is American Heart Month
For the latest news and events from the American Heart Association
visit: http://www.americanheart.org
- March 12-18 National PTA Alcohol
& Drug Awareness Week
Check your school calendar for awareness events.
- March is National Nutrition Month
Find healthy eating tips and events through the National
Institutes of Health (NIH) at: http://dnrc.nih.gov/nutrition_month.htm.
Learn to live a longer, better, and healthier life. Register
for the National Steps to a Healthier U.S. Summit, April
29-30 in Baltimore, MD: http://healthierus.gov
Back to Table of Contents
Visit the FDA & YOU booth at
the
NASSP Annual Convention & Exposition - Booth 1237
See you in sunny Orlando, Florida!!! |
| About FDA & You
FDA & You is an FDA publication to inform
and encourage health educators and students to learn
about the latest FDA medical device and health news.
The publication's contents may be freely reproduced.
Comments should be sent to the Editor.
Editor: Alicia Witters
Assistant Editor: Edie Seligson
Researcher: Carol Clayton
Email: FDAandyou@cdrh.fda.gov
Read us online at: http://www.fda.gov/cdrh/fdaandyou
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Rockville, MD 20850
Special thanks to CBER, CDER and CFSAN
for contributing to this issue. |
|
