CDC recommendations for DENTISTRY, Fen-Phen patients

From: Joel M. Eichen (joeleichen_at_yahoo.com)
Date: 03/23/05 

Date: Wed, 23 Mar 2005 18:08:21 -0500

http://www.pronational.com/news/denrprtr/Fenphen-0698.htm

Fen-Phen Litigation......Picking Up Steam
By Theodore Passineau, J.D., ProNational Senior Health Care Advisor

Not since the breast implant cases of the late 1980s and early 1990s
has there been such a flurry of legal activity associated with a
particular form of medical treatment. The weight reduction drugs
commonly known as Fen-Phen, fenfluramine (or its sister drug,
dexfenfluramine) and phentermine, have made their way into headlines
and courtrooms. With over 18 million prescriptions having been written
to an estimated 6 million Americans, the potential for litigation
related to heart and lung damage is significant.

The controversy began to take shape in August of 1997 when The New
England Journal of Medicine (NEJM) reported the potential for heart
valve problems and/or pulmonary hypertension resulting from the use of
fenfluramine and phentermine in combination. While each drug had been
approved by the FDA for use individually, the use of the medications
in combination had never been approved. There were reports of
cardiac-related problems in as high as 32 percent of the users of
these combined medications. Subsequent reports have suggested
cardiac-related problems with the use of fenfluramine or
dexfenfluramine alone.

The usual defendants in these cases are the pharmaceutical companies
who manufactured the medications and the physicians who prescribed
them. Several cases have been brought as class actions in federal
court (and are being consolidated into one federal court case in
Philadelphia); others have been brought as state class actions. In
addition, many individual suits are being filed in state courts. It is
expected that, in time, cases will have been filed in all 50 states.

The Fen-Phen controversy is also important for dentists. Whenever a
condition is associated with increased risk of subacute bacterial
endocarditis, such as cardiac valvulopathy, the dentist must take
appropriate prophylactic measures prior to initiating treatment.
Prophylactic measures begin with identifying the potentially dangerous
condition.

In 1992, a ProNational study of office practices found that
approximately 94% of general dentists use a patient-completed health
history form. This is an excellent means of gathering essential
clinical historical information. Health history forms should now be
amended to include a question that asks whether the patient has ever
taken prescription weight-reduction drugs. (Don't depend on the
patient to recognize the names of these drugs.) If a positive response
is elicited, you should determine the exact medications taken.

Before treating a patient who has taken Fen-Phen or fenfluramine
products alone, the CDC (Centers for Disease Control) guidelines
should be consulted. (See guidelines below.) Additionally, you should
be familiar with the American Dental Association's recommendations,
which are listed below.

Because dentists weren't involved in the prescribing of Fen-Phen or
fenfluramine products, professional liability exposure for dentists
should be very limited. However, inattention to the possibility of SBE
(subacute bacterial endocarditis) as a result of previous use of diet
medications is one way that members of the dental community could be
drawn into the Fen-Phen debate. Conscientious history taking and
recording and adherence to the CDC guidelines and ADA recommendations
should eliminate this potential.

You may call ProNational's Risk Management Department at 800/292-1036
for further information on issues related to the prescription of
Fen-Phen or fenfluramine products.

CDC Recommendations Regarding Fen-Phen

1. All persons exposed to fenfluramine or dexfenfluramine, for any
period of time, either alone or in combination with other agents,
should undergo a medical history and cardiovascular examination by
their physician to determine the presence or absence of
cardiopulmonary signs or symptoms.

2. An echocardiographic evaluation should be performed on all
persons who were exposed to fenfluramine or dexfenfluramine for any
period of time, either alone or in combination with other agents, and
who exhibit cardiopulmonary signs (including a new murmur) or symptoms
suggestive of valvular disease (e.g., dyspnea).

3. Although the clinical importance of asymptomatic valvular
regurgitation in exposed patients and the risk for developing
bacterial endocarditis in these patients are unknown, practitioners
should strongly consider performing echocardiography on all persons
regardless of whether they have cardiopulmonary signs or symptoms who
have been exposed to fenfluramine or dexfenfluramine for any period of
time, either alone or in combination with other agents, BEFORE the
patient undergoes any invasive procedure for which antimicrobial
endocarditis prophylaxis is recommended by 1997 AHA (American Heart
Association) guidelines.

Any echocardiographic findings that meet the AHA criteria for
prophylaxis regardless of whether they are attributable to possible
fenfluramine or dexfenfluramine use should be recognized as
indications for antibiotic prophylaxis. The invasive procedures
include certain medical or dental procedures where antibiotic
prophylaxis is recommended as defined by the 1997 AHA guidelines. For
emergency procedures for which cardiac evaluation cannot be performed,
empiric antibiotic prophylaxis should be administered according to the
1997 AHA guidelines.

4. Because of the prevalence of minimal degrees of regurgitation in
the general population, the current case definition of drug-associated
valvulopathy should include exposed patients with
echocardiographically demonstrated AR of mild or greater severity
and/or MR of moderate or greater severity, based on published
criteria.

ADA Recommendations Regarding Fen-Phen -- 11/12/97

Dentists who have patients who were on Fen-Phen (fenfluramine and
phentermine) or dexfenfluramine or fenfluramine alone, should refer
them to their physician for the CDC-recommended evaluation and
treatment before conducting any dental procedures that may cause
significant bleeding.

Based on what the evaluation reveals, the dentist may then provide
necessary dental treatment in accordance with the revised 1997
guidelines titled: "Prevention of Bacterial Endocarditis:
Recommendations by the American Heart Association and A Statement for
the Dental Profession." (These guidelines were approved by the ADA's
Council on Scientific Affairs and published in the August, 1997
Journal of the American Dental Association.)

Under these guidelines, the dentist may prescribe a single
pre-procedure dose of antibiotics for appropriate patients who are
undergoing procedures that put them at risk for significant bleeding.

Examples of dental procedures that might warrant antibiotic treatment
include, but are not limited to, tooth extractions, periodontal (gum)
surgery, root canal treatment and the placement of orthodontic bands
but not brackets.
 
    
 

© Copyright 2005 ProNational, Inc. All Rights Reserved

 

On Tue, 22 Mar 2005 22:40:25 -0500, "Andrew B. Chung, MD/PhD"
<andrew@heartmdphd.com> wrote:

>"Joel M. Eichen" wrote:
>>
>> Hello Sharon,
>>
>> Here is some more information on the "reversed" case.
>>
>> Joel M. Eichen D.D.S.
>>
>> **
>>
>> Posted on Wed, Feb. 23, 2005
>>
>>
>>
>>
>> Judge reverses verdict against Wyeth over diet drug
>>
>> Associated Press
>>
>> MADISON, N.J. - A judge in Philadelphia reversed a jury verdict
>> against drug maker Wyeth Wednesday, ruling that a plaintiff who
>> alleged heart valve injury from use of a diet drug knew the risks
>> before she took the drug.
>>
>> Common Pleas Court Judge Mark I. Bernstein set aside a Nov. 3, 2004
>> verdict that awarded Geri McMurdie $780,000 in compensatory damages.
>> In his ruling, Bernstein said that McMurdie "knowingly and voluntarily
>> assumed the risks" of heart damage when she signed a consent form
>> acknowledging the potential risks of Pondimin.
>
>*Sigh*
>
>What people subject themselves to in order to avoid simply eating less
>to lose weight.
>
>
>At His service,
>
>Andrew

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