#3 - Spring/Summer 2003
On April 12th FDA banned the sale of all dietary supplements
containing ephedra. A thorough investigation into the effects
of ephedra by FDA and independent investigators determined
that ephedra presents an unreasonable risk of illness or injury,
and should not be consumed.
This means people should stop buying and using ephedra products
immediately. FDA is also working to remove these products
from the market.
Americans and Dietary Supplements
Former FDA Commissioner Dr. Mark McClellan has noted that
too many people are using dietary supplements as a quick fix
for being overweight or obese. "Dietary supplements may
help you lose weight, but they [can] also pose health risks."
In 1999 more than half of Americans used "dietary supplements,"
as the term is defined in the Dietary Supplement Health and
Education Act (DSHEA) of 1994. Dietary supplements include
vitamins, amino acids, enzymes, and herbs and other botanicals.
The use of most dietary supplements does not appear to be
associated with any serious adverse health effects, and there
is evidence that supplements can have health benefits. For
example, it is well recognized that calcium helps build strong
bones and prevent osteoporosis.
Ephedra, also called Ma huang, is a plant derived dietary
supplement. Its principal active ingredient is ephedrine,
which when chemically altered is regulated by FDA as a drug.
While products containing natural ephedrine have long been
used to treat certain respiratory symptoms in traditional
Chinese medicine, in recent years ephedra products have been
extensively promoted as weight loss aids and sports performance
and energy boosters.
However, recent studies have found little evidence for ephedra's
effectiveness other than for short-term weight loss. Studies
also show that the substance raises blood pressure and otherwise
stresses the heart, reactions linked to harmful health outcomes
such as heart problems and strokes.
The Ephedra Ban
The ephedra ban is a continuation of a process that began
in 1997 when FDA first proposed to require a statement on
dietary supplements with ephedra, warning that they are hazardous
and should not be used for more than 7 days. FDA modified
this proposed rule in 2000, and in February 2003 it announced
a series of measures that included strong enforcement actions
against companies making unproven claims for their ephedra-containing
By law (DSHEA), the manufacturer is responsible for ensuring
that its dietary supplement products are safe before they
are marketed. Unlike drug products that must be proven safe
and effective for their intended use before marketing, there
are no provisions in the law for FDA to "approve"
dietary supplements for safety and effectiveness before they
reach the consumer.
However, the law allows FDA to prohibit sale of a dietary
supplement if it "presents significant or unreasonable
risk of injury. FDA must determine if a product's known or
supposed risks outweigh any known or suspected benefits. This
decision is made based on available scientific evidence in
light of claims the product makes and in light of the product's
being sold directly to consumers without medical supervision.
Prior to the ephedra ban, FDA sent dozens of warning letters
to companies marketing dietary supplements that contain ephedrine.
The letters explained that any claims their products made
about effects on the structure and function of the human body
had to be truthful and not misleading.
The letters also warned firms not to make claims about a
products' ability to treat or cure a disease or condition
such as obesity. Under the Federal Food, Drug and Cosmetic
Act, unapproved products making "disease claims"
are unapproved new drugs and therefore subject to other regulatory
actions. This includes the court ordered blockage of sales
and the seizure of products.
It is important to be well informed about any product before
buying it. Because it can be difficult to know what information
is reliable and what is questionable, you may first want to
contact the manufacturer about a product you intend to buy.
The name and address of the manufacturer or distributor can
be found on the label of the dietary supplement.
Also know that any dietary supplement that is promoted on
its label as a treatment, prevention or cure for a specific
disease or condition is considered an illegal drug. Do not
buy dietary supplements that make these, or similar, claims.
Reporting Problems with Dietary Supplements
If you think you have suffered a serious harmful effect or
illness from a product FDA regulates, including dietary supplements,
the first thing you should do is contact your doctor or other
healthcare provider immediately. Then, you and your healthcare
provider are encouraged to report this problem to FDA.
Your healthcare provider can call FDA's MedWatch hotline
at 1-800-FDA-1088, by FAX to 1-800-FDA-0178 or online at:
For more information visit: http://www.fda.gov/oc/initiatives/ephedra/february2004/
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you know that a single organ donor can save or enhance the
lives of up to 50 other people?
April is National Donate Life Month and this year marks the
50th anniversary of the first successful U.S. organ transplant.
With that in mind, there's no better time to learn about
the organ donation process. The Department of Health and Human
Services has launched a new website http://www.organdonor.gov/student
to help teens make an informed decision about organ donation.
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in on Obesity
Americans are getting fatter. We're putting on the pounds
at an alarming rate, and sacrificing our health for the sake
of supersize portions, biggie drinks, and two-for-one value
meals, obesity researchers say.
According to the Centers for Disease Control and Prevention
(CDC) about 15% of children and adolescents are overweight.
Excess weight and physical inactivity account for more than
300,000 premature deaths each year in the United States, second
only to deaths related to smoking. And the list of related
health problems is long. People who are overweight or obese
are at increased risk for high blood pressure, high cholesterol,
diabetes, heart disease, certain cancers such as breast and
colon, depression, and other illnesses.
Former FDA commissioner Dr. Mark McClellan has called the
current policies and advice to the public on obesity ineffective.
Recently Dr. McClellan called on researchers, the food industry,
consumer groups, and the medical community to work with the
FDA to tackle this epidemic.
refers to an excess of body weight, but not necessarily body
fat. Obesity means an excessively high proportion of body
fat. Health professionals use a measurement called body mass
index (BMI) to classify an adult's weight as healthy, overweight,
or obese (see the BMI chart, "Are You at a Healthy Weight?").
BMI describes body weight relative to height and is correlated
with total body fat content in most adults.
To get your approximate BMI, multiply your weight in pounds
by 703, then divide the result by your height in inches, and
divide that result by your height in inches a second time.
(Or you can use the interactive BMI calculator at http://www.nhlbisupport.com/bmi/bmicalc.htm.)
A BMI from 18.5 up to 25 is considered in the healthy range,
from 25 up to 30 is overweight and 30 or higher is obese.
Generally, the higher a person's BMI, the greater the risk
for health problems, according to the National Heart, Lung
and Blood Institute (NHLBI). However, there are some exceptions.
For example, very muscular people, like body builders, may
have a BMI greater than 25 or even 30, but this reflects increased
muscle rather than fat. "It is excess body fat that leads
to the health problems such as type 2 diabetes, high blood
pressure, and high cholesterol," says Eric Colman, M.D.,
of the Food and Drug Administration's Division of Metabolic
and Endocrine Drug Products.
Obesity, once thought by many to be a moral failing, is now
often classified as a disease. The NHLBI calls it a complex
chronic disease involving social, behavioral, cultural, physiological,
metabolic, and genetic factors. Although experts have many
theories on how and why people become overweight, they generally
agree that the key to losing weight is a simple message: Eat
less and move more. Your body needs to burn more calories
than you take in.
Setting a Goal
Studies show that if you are overweight you can improve your
health with just a small amount of weight loss. The first
step to weight loss is setting a realistic goal. By using
a BMI chart and consulting with your health-care provider,
you can determine what a healthy weight is for you.
To reach your goal safely, plan to lose weight gradually.
A weight loss of one-half to 2 pounds a week is usually safe,
according to the Dietary Guidelines for Americans. This can
be achieved by decreasing the calories eaten or increasing
the calories used by 250 to 1,000 calories per day, depending
on current calorie intake. (Some people with serious health
problems due to obesity may lose weight more rapidly under
a doctor's supervision.) If you plan to lose more than 15
to 20 pounds, have any health problems, or take medication
on a regular basis, a doctor should evaluate you before you
begin a weight-loss program.
Dieting may conjure up visions of eating little but lettuce
and sprouts, but you can enjoy all foods as part of a healthy
diet as long as you don't overdo it on fat (especially saturated
fat), protein, sugars, and alcohol. To be successful at losing
weight, experts say you need to change your lifestyle not
just go on a diet.
Limit portion sizes, especially of foods high in calories,
such as cookies, cakes and other sweets; french fries; and
fats, oils and spreads. Reducing dietary fat without reducing
calories will not produce weight loss, according to the NHLBI's
guidelines on treating overweight and obesity in adults.
Use the Food Guide Pyramid, developed by the U.S. Department
of Agriculture (USDA) and the Department of Health and Human
Services, to help you choose a healthful assortment of foods
that includes vegetables, fruits, grains (especially whole
grains), fat-free milk, and fish, lean meat, poultry, or beans.
Choose foods naturally high in fiber, such as fruits, vegetables,
legumes (such as beans and lentils), and whole grains. The
high fiber content of many of these foods may help you to
feel full with fewer calories.
All calorie sources are not created equal. Carbohydrate and
protein have about 4 calories per gram, but fat has more than
twice that amount (9 calories per gram). Just as for the general
population, weight-conscious consumers should aim for a daily
fat intake of no more than 30 percent of total calories.
Keep your intake of saturated fat at less than 10 percent
of calories. Saturated fats increase the risk for heart disease
by raising blood cholesterol. Foods high in saturated fats
include high-fat dairy products (like cheese, whole milk,
cream, butter, and regular ice cream), fatty fresh and processed
meats, the skin and fat of poultry, lard, palm oil, and coconut
Limit your use of beverages and foods that are high in added
sugars, not naturally occurring sugars in foods such as fruit
or milk. Foods containing added sugars provide calories, but
may have few vitamins and minerals. In the United States,
the major sources of added sugars include non-diet soft drinks,
sweets and candies, cakes and cookies, and fruit drinks and
Using the Food Label
Under regulations from the FDA and the USDA, the food label,
found on almost all processed foods, offers more complete,
useful and accurate nutrition information than ever before.
Even when restricting calories and portions, you can use the
part of the food label called the Nutrition Facts panel to
make sure you get all the essential nutrients for good health.
You'll find the serving size and the number of servings per
package listed at the top of the Nutrition Facts panel. The
serving size affects all the nutrient amounts listed on the
panel. For example, if there is one cup in a serving and the
package contains two servings, you need to double the calories
and other nutrient numbers if you eat the whole package. Many
items sold as single portions--like a 20-ounce soft drink,
a 3-ounce bag of chips, and a large bagel--actually provide
two or more servings.
The Nutrition Facts panel also shows how much dietary fiber,
vitamin A, vitamin C, calcium, and iron are contained in a
serving. These are nutrients you need for good health. Also
listed on the Nutrition Facts panel are the amounts of carbohydrates,
protein, and sugars contained in a serving. Use the panel
to compare the amount of total sugars among similar products,
and try to choose ones lower in sugars.
In addition to listing some nutrients by weight, the panel
also gives this information as a Percent Daily Value (%DV).
The %DV shows how a serving of a food fits in with recommendations
for a healthful diet and allows consumers to make comparisons
between similar products.
For example, shoppers can use the %DV figures to find out
which frozen dinner is lower in saturated fat--particularly
when it involves a comparative nutritional claim, such as
reduced-fat. Foods with 5 percent or less of the Daily Value
are considered low in a nutrient, while those with 20 percent
or more are high in the nutrient.
The %DVs are based on a 2,000-calorie daily diet. But even
if you eat less than 2,000 calories, the %DV can be used to
determine whether a food is high or low in a particular nutrient.
For further guidance on using the Nutrition Facts panel,
visit FDA's Center for Food Safety and Applied Nutrition (http://www.cfsan.fda.gov/list.html).
Increasing Physical Activity
Most health experts recommend a combination of a reduced-calorie
diet and increased physical activity for weight loss. Most
adults should get at least 30 minutes and children should
get 60 minutes of moderate physical activity on most, and
preferably all, days of the week. But fewer than 1 in 3 U.S.
adults gets the recommended amount of physical activity, according
to The Surgeon General's Call To Action To Prevent and Decrease
Overweight and Obesity.
In addition to helping to control weight, physical activity
decreases the risk of dying from coronary heart disease and
reduces the risk of developing diabetes, hypertension, and
colon cancer. Researchers also have found that daily physical
activity may help a person lose weight by partially lessening
the slow-down in metabolism that occurs during weight loss.
Exercise does not have to be strenuous to be beneficial.
And some studies show that short sessions of exercise several
times a day are just as effective at burning calories and
improving health as one long session.
For More Information
Weight-control Information Network (WIN)
National Institute of Diabetes and Digestive and Kidney Diseases
Obesity Education Initiative
National Heart, Lung, and Blood Institute
The Surgeon General's Call to Action To Prevent and Decrease
Overweight and Obesity, 2001
U.S. Department of Health and Human Services
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Safety: Protect the Skin You’re In!
Skin: we can't live without it. It's both the largest organ
of the body and one of the most mistreated. It's vital for
protecting and regulating the body and can provide amazing
insight into a person's state of health. Yet some ignore the
warnings of premature aging and worse to pursue a love affair
with the sun.
The Effects of Tanning
Exposure to ultraviolet (UV) radiation, either from sunlight
or by artificial sources, such as tanning beds and sunlamps,
contributes to the risk of developing skin cancer. Prolonged
exposure to the sun can cause wrinkling, loss of elasticity,
and other signs of premature skin aging. Since sun damage
may not be immediately visible, many people don't realize
the dangers of tanning. In fact, any tan is a sign of the
skin adapting to potentially damaging UV radiation. Tanning
occurs when the skin produces additional coloring (pigment),
trying to adapt to protect itself against sunburn. The most
serious outcome of overexposure to the sun is skin cancer,
a delayed effect that usually doesn't show up for many years.
Although some exposure to the sun is important to make sure
a person gets enough vitamin D, about 20 minutes of sun a
day on the face and hands is considered enough for this purpose.
Health and Human Services Secretary Tommy G. Thompson strongly
warns teens to take simple preventive steps now to help avoid
skin cancer later. "Even a few serious sunburns,"
he says, "can increase a person's risk for skin cancer."
UVA v. UVB
Sunburn is associated with the shorter wavelengths of UV
radiation, known as ultraviolet B (UVB). The longer wavelengths,
known as ultraviolet A (UVA), however, can penetrate the skin
and damage connective tissue at deeper levels, even if the
skin's surface feels cool. It is important to limit exposure
to both UVA and UVB.
Indoor tanning can be as harmful as outdoor tanning. More
than 1 million people visit tanning salons on an average day,
according to the American Academy of Dermatology (AAD). But
many don't know that indoor tanning devices, such as tanning
beds and sunlamps, emit UV radiation that's similar to and
sometimes more powerful than the sun. As a result, the FDA
discourages the use of tanning beds and sunlamps.
Be wary of claims about "safe rays" because there
is no such thing. Both types of ultraviolet light, UVB and
UVA, can cause wrinkling and other signs of premature skin
aging, skin cancer, and damage to the eyes and the immune
Sunlamps used for tanning produce UV radiation. FDA policies
require sunlamp product manufacturers to develop an exposure
schedule and establish a maximum recommended exposure time
based on the UV emission characteristics of their products.
FDA also warns that, while some tanning operators may claim
that UVA sunlamps are safer than both the sun and UVB lamps,
this has not been definitely shown. In fact, exposure to UV
radiation from sunlamps adds to the total amount of UV radiation
people get from the sun during their lifetimes and potentially
increases their risk of cancer.
According to the National Cancer Institute, the incidence
of skin cancer is already increasing each year, and melanoma,
the most serious form, is increasing by 3 percent annually.
In fact, statistics indicate that 1 out of 7 people in the
United States will develop some form of skin cancer during
their lifetimes, with the rate increasing as the population
ages. People with pale skin, red hair and freckles are at
the highest risk for skin cancer.
During the last few years, some companies have offered a
sunless option that involves spraying customers in a tanning
booth with the color additive dihydroxyacetone (DHA). DHA
interacts with the dead surface cells in the outermost layer
of the skin to darken skin color.
DHA has been approved by the FDA for use in coloring the
skin since 1977, and has typically been used in lotions and
creams. Its use is restricted to external application, which
means that it shouldn't be sprayed in or on the mouth, eyes,
or nose because the risks, if any, are unknown. If you choose
to use DHA spray at home or in tanning booths, be sure to
cover these areas.
There are no tanning pills approved by the FDA. Some companies
have marketed tanning pills that contain the color additive
canthaxanthin. When large amounts of canthaxanthin are ingested,
the substance can turn the skin a range of colors, from orange
to brown. However, canthaxanthin is only approved for use
as a color additive in foods and oral medications, and only
in small amounts.
Tanning pills have been associated with health problems,
including an eye disorder called canthaxanthin retinopathy,
which is the formation of yellow deposits on the eye's retina.
Canthaxanthin has also been reported to cause liver injury
and a severe itching condition called urticaria, according
to the AAD.
When Tanning, Beware of the Dangers
Harmful rays from the sun, sunlamps and tanning beds may
- skin cancer, which can be deadly,
- eye problems,
- weakened ability to fight disease,
- unsightly skin spots, or
- wrinkles and "leathery" skin.
For more information on tanning and sun safety,
All of the abbreviations and terms on sunscreen bottles
can make buying sunscreen confusing. Clip this section
and take it with you the next time your family buys
sunscreen to help you interpret the labels.
SPF Sun Protection Factor and the
number next to it refer to the degree to which a sunscreen
can protect the skin from sunburn. The higher the number,
the more sunburn protection the sunscreen can provide.
You should use a minimum of SPF 15 and reapply often
UV or UVR Ultraviolet radiation from
the sun that can cause sunburn, wrinkling, premature
aging, and skin cancer and may also interfere with the
body's immune system. Look for "broad spectrum"
sunscreens that protect from the two types of UV rays.
UVA Ultraviolet A is longer wavelength
UV radiation that can penetrate and damage the deeper
layers of skin even if the skin feels cool and shows
no signs of burning.
UVB Ultraviolet B is the shorter wavelength
UV radiation associated with sunburn and other skin
Water Resistant These sunscreens stay
on the skin longer even if they get wet from pool water,
ocean water or sweat. But water resistant doesn't mean
waterproof. Sunscreens with this label still need to
be reapplied. Check the label for reapplication times.
Yourself with These Sun Safety Tips:
- Avoid the sun, or seek shade, from 10 a.m. to 4
p.m. when the sun's rays are strongest. Even on a
cloudy day, up to 80% of the sun's rays can get through.
- Apply an SPF 15 or higher sunscreen evenly to all
uncovered skin before going outside. Check the label
for the correct amount of time to apply sunscreen
before you go out. If the label does not give a time,
allow about 15 to 30 minutes.
- Don't forget to apply sunscreen to your eyelids,
lips, nose, ears, neck, hands and feet.
- Avoid getting sunscreen in your eyes. It can sting.
- If you don't have much hair apply sunscreen to
the top of your head or wear a hat.
- Reapply sunscreen often. Read the label to see
how often you need to reapply.
- Wear protective clothing and a wide-brimmed hat
to protect your head and face.
- Wear sunglasses with 99% to 100 % UV protection
to protect your eyes.
- Avoid artificial tanning methods such as sunlamps,
tanning beds, tanning pills and tanning makeup.
- If you still choose to use sunlamps or tanning
beds, follow the manufacturer's recommended exposure
schedule and always wear FDA-compliant protective
- Check your skin regularly for signs of skin cancer.
- Ask a doctor before applying sunscreen to children
under 6 months of age.
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a Skin Cancer Check
No matter how much time you spend in the sun, you should
protect yourself by checking for signs of skin cancer. Do
a thorough body check and look for changes in the size, shape,
color or feel of birthmarks, moles and spots. If you find
any changes or find sores that are not healing, let your doctor
know right away.
Use a hand mirror or full-size mirror and follow these easy
- Check the back of your neck, ears and scalp.
- Check your body and head- front, back and sides.
- Bend your elbows and check the underside of your arms.
- Check all in-view parts like fingers, hands and feet.
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Before you think about getting a henna tattoo this summer,
you should consider the consequences. Products marketed as
henna may contain other ingredients that can result in mild
to severe allergic reactions and infections that can lead
to permanent scarring.
What is henna?
Henna is a brown to reddish brown dye made from the leaves
of the Lawsonia plant, a flowering shrub native to North Africa
and Asia. Although decorating the skin with henna has become
popular, henna is not approved for application to the skin,
as in the body-decorating process known as "mehndi."
Henna is approved by the FDA only for use as a hair dye.
Since henna typically produces a brown, orange-brown, or
reddish-brown tint, other ingredients must be added to produce
other colors, such as those marketed as "black henna"
and "blue henna." So-called "black henna"
may contain the "coal tar" color p-phenylenediamine,
also known as PPD. This ingredient may cause allergic reactions
in some people. The only legal use of PPD in cosmetics is
as a hair dye (and that definitely does not include eyelashes
or eyebrows, where such dyes may cause blindness). It is not
approved for direct application to the skin. In addition to
color additives, these skin-decorating products may contain
other ingredients that can also cause allergic reactions.
Even brown shades of products marketed as henna may contain
other ingredients intended to make them darker or make the
stain last longer.
How do I know what's in a temporary tattoo or henna/mehndi
Cosmetics including temporary skin-staining products that
are sold on a retail basis to consumers must list their ingredients
on the label. Products that do not list ingredients violate
the Fair Packaging and Labeling Act (FPLA) and cannot legally
be sold in this way.
The FPLA does not apply to cosmetic samples and products
used exclusively by professionals. For example, the requirement
for ingredient listing does not apply to henna applied at
a salon, or in a booth at a fair or boardwalk.
Does FDA approve color additives?
By law, except for coal tar colors used in hair dyes, color
additives used in cosmetics must be approved by FDA to assure
that they are safe and suitable for their intended uses. Some
color additives may not be used unless FDA has certified in
its own labs that the composition of each batch meets the
regulatory requirements. For example, temporary tattoo products
that do not comply with restrictions on color additives cannot
legally be sold.
How do I report an adverse reaction to a temporary
tattoo or other cosmetic?
FDA urges the public and healthcare providers to report adverse
reactions involving cosmetics, including henna and temporary
tattoos by contacting their FDA district office (see the blue
pages of your local phone directory) or FDA's Center for Food
Safety and Applied Nutrition (CFSAN) Adverse Events Reporting
System (CAERS) by phone at (301) 436-2405 or by email at CAERS@cfsan.fda.gov.
In addition, healthcare professionals and consumers may submit
information about adverse events to MedWatch, the FDA Medical
Products Reporting Program, as follows:
Consumers may obtain MedWatch reporting forms by calling
the following FDA toll-free number: (888) 463-6332 [888-INFO-FDA].
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Buying Medical Products Online
A healthy dose of common sense can help to protect you when
shopping at pharmaceutical and other medical product websites.
The number of online pharmaceutical sites grows daily and
many of these sites bypass the traditional procedures and
safeguards for prescribing medications.
Some sites sell products that are not approved by the Food
and Drug Administration, or if they deal in approved products,
may sidestep established procedures designed to protect consumers.
"As we close down one illegal site, other illegal sites
spring up," says Tom McGinnis, R.Ph., a pharmacist and
FDA's deputy associate commissioner of health affairs. McGinnis
added, "The best way for us to protect consumers is to
educate them in the do's and don'ts of safe online shopping
for medical products.
Here are some do's and don'ts to help you safely purchase
medical products online:
DO use only
medications that have been prescribed by your doctor or other
authorized healthcare provider.
DO buy only
from sites that require prescriptions from a physician or
other authorized health care provider and that verify each
prescription before dispensing medication.
DO use sites
that provide convenient access to a licensed pharmacist who
can answer you questions.
on a topic in
FDA & YOU?
Contact FDA by phone:
Or search the FDA website: http://www.fda.gov
DO check with
your state board of pharmacy or with the National Association
of Boards of Pharmacy (NABP) at www.nabp.net. Some sites display
the NABP VIPPS™ (Verified Internet Pharmacy Practice
Sites™ ) seal, an assurance that such sites meet all
applicable state and federal regulations.
DO buy only
from U.S.-based sites.
DO report problems.
If you suspect a site is not a licensed pharmacy, don’t
buy from it. Report the site and any complaints to the FDA
DON'T buy from
sites that offer to prescribe a medication for the first time
without a physical exam by your doctor or that sell prescription
medication without a prescription.
DON'T buy from
sites that include undocumented case histories claiming amazing
DON'T buy from
sites without posted customer service policies.
For more information, visit http://www.fda.gov/oc/buyonline
or call 1-888-INFOFDA.
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Safe Use of Over-the-Counter Drugs
Pharmacy shelves are filled with medicines that can be bought
without a prescription. But be aware that just because a drug
is available over the counter (often abbreviated OTC) doesn't
mean it's free of side effects.
OTC drugs should be taken with the same caution as drugs
prescribed by your doctor. Special care is necessary if you
use more than one of these products at the same time, or if
you take an OTC product while also being treated with a prescription
product. And there are some OTC drugs that shouldn't be taken
by people with certain medical problems. If possible, ask
your parent, pharmacist or physician for advice before taking
any OTC product you haven't used before.
Besides getting expert advice, the most important thing you
can do before buying an OTC drug is to read the label. The
name of the product isn't always the same as the name of the
drug it contains, and some products contain more than one
ingredient. For example, a product for coughs and one for
colds might each contain phenylpropanolamine. A person taking
both products at the same time might get too much of this
ingredient, which is also in some OTC diet pills.
Aspirin and Other Fever Reducers
Reading the label is especially important when it comes to
products containing aspirin (acetylsalicylic acid) or their
chemical cousins, other salicylates, which are used to reduce
fever or treat headaches and other pain.
Teens (as well as children) should not take products containing
aspirin or salicylates when they have chickenpox, flu, or
symptoms that might be the flu (this includes most colds).
Children and teenagers who take aspirin and other salicylates
during these illnesses may develop a rare but life-threatening
condition called Reye syndrome. (Symptoms usually occur near
the end of the original illness and include severe tiredness,
violent headache, disorientation, and excessive vomiting.)
Acetaminophen (sold under brand names such as Tylenol) can
also reduce fever and relieve pain and has not been associated
with Reye syndrome. Remember though, because fevers in most
colds don't normally go above 100 degrees Fahrenheit and don't
cause much discomfort, you usually don't have to take any
drug for the fever. If you think you have a cold but your
temperature is running higher, consult your doctor because
you might have flu or a bacterial infection.
Sniffle and Cough Combinations
OTC drugs to relieve stuffy noses often contain more than
one ingredient. Some of these products are marketed for allergy
relief and others for colds. They usually contain both an
antihistamine and a nasal decongestant. The decongestant ingredient
"un-stuffs" nasal passages while antihistamines
dry up a runny nose. But some of these products may also contain
aspirin or acetaminophen, and some contain a decongestant
alone. Some of these drugs are "extended-release"
or "long-acting" preparations that continue to work
for up to 12 hours. Others are immediate-release products
and usually work for four to six hours. It's important to
read the label, and check with the pharmacist, to be sure
you're getting the right product for your symptoms.
Most antihistamines can cause drowsiness, while many decongestants
have the opposite effect. Still, it's hard to predict whether
any one product will make you sleepy or keep you awake--or
neither--because reactions to drugs can vary from one person
to another. So it's best not to drive or operate machinery
until you find out how the drug affects you. In addition,
alcohol, sedatives and tranquilizers intensify the drowsiness
effect of antihistamines, so it's best not to take them at
the same time unless a doctor tells you to.
As you can see, selecting a product to treat a stuffy nose
can be tricky. So can choosing a product to treat a cough.
In addition to one or more ingredients specifically for coughs,
many cold or cough syrups contain the same ingredients that
are in allergy and cold pills. This means that if you're taking
acetaminophen pills or cold pills, you should read the label
or consult the pharmacist to make sure you're not getting
a double dose of ingredients by taking a cold or cough syrup.
There are several different types of ingredients to treat
coughs, depending on the kind of cough you have. Some ingredients
make it easier for you to bring up phlegm, while others suppress
the cough. Before taking any kind of cough medicine, it's
a good idea to first try drinking plenty of liquids and adding
moisture to the air by using a vaporizer or boiling water.
Sometimes just doing these things will reduce the cough enough
that you won't have to take any medicine. If a cough lasts
more than a few days, see your doctor.
When your stomach gets upset, you’ll want the quickest
relief possible. But unless the problem continues for several
days or is severe, drugs are not usually necessary.
If you're constipated, drinking more water, getting more
exercise, and eating high-fiber foods such as fruits and vegetables,
will often solve the problem.
Though appropriate for some medical conditions, laxatives
can be habit forming and can make constipation worse when
overused. Not having a bowel movement every day does not necessarily
mean that you're constipated, for some people it's normal.
If you have diarrhea, it's a good idea to rest, eat only
small amounts of food at a time, and drink plenty of fluids
to prevent dehydration. OTC products marketed to stop diarrhea
may contain loperamide (Imodium A-D), or attapulgite (Diasorb,
Kaopectate and others), or bismuth subsalicylate (Pepto-Bismol
and others). Teens should avoid products with bismuth subsalicylate
if they have flu or chickenpox symptoms because of the risk
of Reye syndrome.
If you're running a fever above 100 F, or if your upset stomach
symptoms are severe or continue for more than a day or two,
consult your doctor. She may recommend one of the many OTC
products available for these problems.
Rashes can be caused by many different things--including
allergies, funguses, and poison oak or ivy. So it's best to
get a doctor's opinion about what's causing your rash before
There are topical OTC products that you apply directly to
the skin available specifically to treat poison ivy and oak.
Some of these products contain calamine, which protects the
skin, and benzocaine, which dulls the pain or itching. Other
products contain an antihistamine or hydrocortisone, which
relieve itching. Antihistamine creams, such as Benadryl, and
hydrocortisone products, such as Cortaid and Caldecort, can
also be used for rashes from allergies and insect bites, but
you shouldn't use them for more than seven days without seeing
Acne, another type of skin problem, can also be treated with
topical OTC products. Many of these lotions (such as Clearasil
products and Oxy-5 and -10) contain benzoyl peroxide in strengths
of 2.5, 5, or 10 percent. It's best to try the lower dosage
level first, to keep your skin from getting too dry.
Benzoyl peroxide can also increase your sensitivity to sun,
causing you to burn more easily. If you use a product with
benzoyl peroxide remember to wear sunscreen during the day
to protect your skin.
These are just a few of the types of products available over
the counter. Their number and uses can be confusing to adults
and teens alike. Before buying any product you haven't already
used, it's best to read the labeling and, if possible, ask
the pharmacist how the product works and what it should be
used for. And, if still in doubt, check with your doctor.
The following products don't have aspirin in their
brand names but they contain aspirin or other salicylates
and shouldn't be taken by teens who have symptoms of
flu or chickenpox unless told to do so by a doctor.
(Ingestion of salicylates during these illnesses increases
children's and teens' risk of Reye syndrome.)
- Alka-Seltzer Effervescent Antacid and Pain Reliever
(also the extra-strength version)
- Alka-Seltzer Plus Night-Time Cold Medicine
- Anacin Maximum Strength Analgesic Coated Tablets
- Ascriptin A/D Caplets (also the regular and extra-strength
- Bayer Children's Cold Tablets
- Bufferin (all formulations)
- Excedrin Extra-Strength Analgesic Tablets and Caplets
- Vanquish Analgesic Caplets
In addition, many products to treat arthritis contain
(This list contains many common products, but isn't
all-inclusive. So be sure to read the label before purchasing
any OTC medication.)
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S M T L O Z K R A L L S O
E U G N I N N A T A L E E K
E P Y A M E P H E D R A V E
T P O I N Z K L I T R N I N
K L C D N F G H D M L N T L
S E O O K G H R Y A L E I O
A M A C D M O I H L T H D I
R E E R B B O N T A R U D B
M N E K E O U J L R O L A R
Z T Y S M P C D A I U Y R C
Y S I U B K L P E B N D O S
L T X L O M C R H K W E L A
Y J H E X E R C I S E L O L
W Z N E E R C S N U S H C E
- Healthy diet
- Buying online
- Color Additives
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
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 CDER, CDRH and CFSAN
for contributing to this issue.