Department of Health
and Human Services interim recommendations for patients who have taken
either fenfluramine or dexfenfluramine

  1. Why has the Department of Health and Human Services 
(DHHS) decided now to publish these
recommendations?

With the withdrawal of fenfluramine and dexfenfluramine
from the US market, many people have asked what they should do if they
have taken these drugs. In order to try to provide guidance, based on the
best information known at present, the Centers for Disease Control and
Prevention (CDC), the Food and Drug Administration (FDA), and the National
Institutes of Health (NIH) (all components of DHHS) collaborated with experts
within the medical community to develop the interim recommendations issued
on November 14. We stress that these recommendations may change as we get
more information on this type of heart valve disease. At present, we believe
these recommendations represent the best advice we can give patients who
have taken these drugs. As we learn more about this type of heart valve
disease, we will continue to discuss these matters with the medical and
patient communities to determine if revisions of these recommendations
are warranted in the future. 

  2. What exactly is DHHS recommending?
Basically, DHHS is recommending three things for people
who have taken fenfluramine or dexfenfluramine for any period of time,
either alone or in combination with other drug products: 

     

    (a) Everyone of these people should see a physician to have a 

    complete medical history taken and physical
    examination 

    performed with particular emphasis on the
    heart and lungs. 

    This examination is to determine primarily
    if  there are any 

    signs  or  symptoms of possible
    heart or lung disease.
    (b) If the physician finds that heart or lung disease may be 

    present,  then these patients should
    have an

    echocardiogram to determine if  there
    is any evidence

    of significant disease of the heart valves. 

    (c) Even if there is no evidence of heart or lung disease by

    history or  on the physical examination,
    in one special

    situation, these patients’  physicians
    should nonetheless

    strongly consider having an echocardiogram
    performed on

    the patient to determine if there is any evidence
    of

    significant disease of the heart valves. That
    situation is IF

    the patient needs to undergo a medical or
    dental

    procedure before which the American Heart
    Association

    recommends giving patients with certain heart
    valvular

    disease an antibiotic to help prevent an infection
    of the

    heart called bacterial endocarditis. The reason
    for the

    echocardiogram in this situation is to determine
    if a

    person without symptoms nonetheless has disease
    of the

    heart valves. If  they do have heart
    valvular disease 

    that needs antibiotic coverage, they need
    the antibiotic

    before undergoing a medical or dental procedure
    that

    could possibly lead to a heart infection.

  3. Are these DHHS recommendations different from the
      earlier recommendations of the American
Heart

      Association (AHA) and  the American
College of

      Cardiology (ACC)?
In the following ways the three recommendations
are similar. All three sets of  recommendations urge that all persons
exposed to these drugs get a thorough medical history and physician examination
with special attention to the heart and lungs. In addition, all three recommend
that those with a new murmur or heart disease symptoms, such as shortness
of breath or swelling in the legs, receive an echocardiogram examination.
The American Heart Association recommendations and these DHHS recommendations
suggest that patients found to have certain types of leaky heart valves
on echocardiogram receive antibiotic coverage before certain medical or
dental procedures. 

Developed in consultation with the American
Heart Association, the American College of Cardiology, and the American
Dental Association,  these DHHS interim recommendations build on the
earlier AHA and ACC recommendations and incorporate new information from
the five investigators who reported their results in patients who had taken
these drugs and were without symptoms indicated that only 17% of patients
with cardiac valve problems diagnosed by echocardiography had a heart murmur
that was    heard on physician examination. As noted by
the American College of Cardiology, obesity may make a heart murmur difficult
for a doctor to hear. Thus, these DHHS interim recommendations suggest
that, regardless of whether signs or symptoms are present, persons who
have taken these drugs and are planning certain medical or dental procedures
that cause bleeding should also have an echocardiographic evaluation before
the procedure. This is important because persons with significant valvular
disease need to receive antibiotic coverage to help protect them from developing
bacterial endocarditis. 

  4. What is an echocardiogram and does it hurt to have it
performed?
An echocardiogram is an ultrasound examination
of the heart. This is basically the same kind of procedure as the ultrasound
examination performed to check the growth of the fetus   
in a pregnant woman. The echocardiogram machine uses ultrasound waves and
a computer to help make a movie of a patient’s heart and heart valve movements
during the routine beating of the heart. This is usually done by placing
a small instrument (transducer) on the chest wall along with some gel to
help make the proper ultrasound connection. There is no pain associated
with routine echocardiograms performed in this manner. 

  5. What is bacterial endocarditis?
Endocarditis is an infection of the tissues
that line the heart chambers and cover the heart valves. Endocarditis can
be caused by bacteria (certain types of germs) getting into  the blood
stream and infecting the heart lining and valve covering as the bacteria-laden
blood is circulated through the heart. The body’s own defense systems do
not work as well in the heart as they do in other parts of the body. As
this type of endocarditis is caused by bacteria, it is called bacterial
endocarditis. 

  6. What is the relationship between leaky heart valves and 
bacterial endocarditis?
When the heart valves are not normal, they
become more likely to develop this infection. Why this occurs is not fully
known; however, years of experience have demonstrated that people with
certain heart valve abnormalities are more likely to get endocarditis than
those without valvular abnormalities if their blood contains enough of
the bacteria that can cause this infection. 

  7. Why can certain medical and dental procedures lead to 
bacterial endocarditis?
Different kinds of bacteria normally are found
in all people’s mouths, rectal areas, and in the tube through which they
urinate (“urethra”). Normally only a small number of these bacteria get
through the tissue barriers in those areas and enter the blood stream,
usually only for a short period of time. In these situations, the body’s
own defense system destroys the bacteria before they can do any harm to
the body. However, when certain medical or dental procedures are performed
in these areas, especially those associated with bleeding, the numbers
of bacteria and the length of time that the bacteria are getting into the
blood stream can increase. This is because of the expected injury to the
tissues that normally form a barrier to the bacteria. These events increase
the chance that the bacteria will have the opportunity to infect an abnormal
heart valve. Antibiotics given just before these types of medical or dental
procedures can help the body’s own defense system destroy the bacteria
that get into the blood stream during the procedure. But even with antibiotics,
bacterial endocarditis cannot be prevented in all cases. 

  8. If persons who have taken these drugs need to have a
      medicalor dental procedure
that can cause bleeding, what

      should they do?
All persons who have taken these drugs should
see their physician and have a careful health history and physical examination
with special attention to the heart and lungs. If a person who has taken
these drugs is planning a non-emergency medical or dental procedure (including,
in some cases, certain dental cleanings) in which bleeding is anticipated,
it is important that the person contact his/her physician to determine
if this is a procedure for which antibiotic coverage is recommended if
the patient has a valvular disorder. It is important to remember that not
all medical or dental procedures result in situations for which antibiotic
coverage is recommended by the American Heart Association for patients
with leaky heart valves. A person’s physician can advise him/her on whether
or not the procedure warrants antibiotic coverage. If it is determined
that antibiotics are recommended before the planned procedure, then persons
who have been exposed to these drugs should undergo an echocardiogram before
the planned procedure. The echocardiogram is performed to determine whether
they have valve leakage of a significant enough degree to require antibiotic
coverage prior to the procedure. 

  9. If I need to have an echocardiogram, how much does it
      cost, and who will pay for it?
The costs of doing and interpreting echocardiograms
varies considerably across the country. Some of the factors that can determine
cost include: 

    (a) whether the examination is performed in a hospital, private 

    office, or clinic; 

    (b) individual physician fee variations; 

    (c) geographic location where the examination was performed; 

    and 

    (d) managed  care reimbursement agreements. You should 

    contact your physician or medical care payer 
    (insurance, 

    HMO, Medicare, Medicaid, etc.) to determine
    how such 

    examinations will be covered in your individual
    case.

10. What medical follow up should I have if I am found to have 
heart valve problems?
As this is a newly recognized concern, we
don’t know yet what happens over time to people with this kind of heart
valve problem. Based on data known at present, many of those patients affected
don’t have any symptoms of heart disease at present and don’t require any
treatment other than careful follow-up by their doctor and pre-treatment
with antibiotics before certain medical or dental procedures, as previously
described in these “Q&As”. The significance of mild heart valve leakage
in patients without symptoms is currently unknown. Some patients with heart
valve problems do develop signs or symptoms of heart disease, such as shortness
of breath, swelling in the legs, chest pain, or heart palpitations (feeling
like your heart is “skipping” beats or is having “irregular” beats). If
this happens, the patient may need additional medical treatment. Some patients
may need referral to a cardiologist (heart specialist). A number of researchers
are trying to determine if the valve problems associated with these drugs
diminish, worsen, or stay the same over time. Over the next year, we should
have more information about what happens to people with these kinds of
leaky valves once they have stopped taking these medications. 

11. Some media reports have suggested that other physicians 
have found much lower rates of valve
disease in persons 

without heart or lung symptoms who
were exposed to

“fen-phen” than reported by FDA.
What could be the

reasons for these differences?
There could be several  reasons that
these reported rates are 

different: 

    (a) the length of time the patients took the drugs, 

    (b) the amount of drug the patients took,

    (c) other medications the patients might have been taking, 

    (d) variations in the way the echocardiograms were interpreted 

    by the readers, or 

    (e) the length of time that had elapsed between the 

    discontinuation of the drug and the time of
    the 

    echocardiogram. There is still a great deal
    to be learned 

    about  this disease.

     One way of more definitely exploring these questions
would be to perform a study in a group of patients that includes both people
who have taken these medications and people who have not taken them but
who are otherwise similar in other characteristics (a “control” group).
This would allow a more precise evaluation of differences  between
the groups. Such a study was performed by Dr. Mehmood Khan in Minneapolis
following the July announcement about the drug-associated valve disease.
Dr. Khan reported his preliminary data this week from this NIH- and CDC-funded
study. His data demonstrated that approximately 25% of the 226 patients
in his study who had taken the drugs had significant  leakage (regurgitation
of mild or greater severity) around their aortic valve compared with only
1% of the 81 control patients in the study who had not taken the drugs
had significant aortic valve leakage. These data are much stronger data
than the survey type data previously reported by FDA or other physicians
quoted in the press. These data continue to undergird the initial concerns
raised about a possible connection between these drugs and the development
of clinically significant cardiac valve disease. 

12. With the removal of these products from the market, what 
should overweight persons do if they
want to improve their 

health?
A person who is less than 20% overweight should
begin a life-long program of moderate physical exercise, such as brisk
walking for 30 to 45 minutes, on most days of the week. Regular moderate
physical activity is likely to improve weight control and will also strengthen
the heart. Overweight persons should also begin to make moderate and life-long
changes in their food choices and eating practices, including reducing
the total amount of calories they eat and ensuring that their diet is low
in saturated fat and rich in fruits and vegetables. 

Persons who have a significant weight problem
are advised to consult their physician to develop a strategy that is individualized
for them. There are a number of options available that a physician can
discuss with the patient. 

13. What future studies are now being planned by the federal
      government regarding diet drugs and
valvular heart disease?

The NIH and CDC are jointly supporting an
echocardiographic study of persons who took these diet drugs along with
a group of persons who did not take the drugs who are matched as to age,
gender, body weight, and weight loss. In addition, there are plans to extend
the follow-up of persons with cardiac valve problems to determine if these
problems improve, worsen, or stay the same. It is likely that the study
will last for another 6 to 12 months. 

14. Are there further sources of  information on this matter?
Further information on general issues regarding:
the use of these drugs, cardiac valve disease, the treatment of obesity,
studies being conducted about these conditions, endocarditis, and echocardiograms
can be found on the websites of various organizations. You can easily get
to the CDC and NIH websites, for example, by using the buttons in this
website that provide immediate links to these and other web sites. 

####

Healthy Weight Network 

Healthy Weight Journal 

402 S. 14th Street 

Hettinger, ND 58639 

701-567-2646 

701-567-2602 fax 

hwj@healthyweight.net

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