Heart Drug for Blacks May Increase Lupus Risk

[Guest guest]

" BiDil...one of its two key ingredients, a generic compound known as

hydralazine hydrochloride, long has been known to cause lupus in some

patients, according to FDA documents and interviews with doctors. ... "

 

(hydralazine hydrochloride is an Antihypertensive and the brand names

in the USA is: Apresazide

http://www.nlm.nih.gov/medlineplus/druginfo/uspdi/202286.html#Brands )

 

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MYCOPLASMA REGISTRY REPORTS

for gulf war syndrome & chronic fatigue syndrome

© Sean Dudley & Leslee Dudley 2005. All rights reserved.

MycoplasmaRegistry/ MycoReg

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Heart Drug Targeted at African Americans Carries Lupus Risk

A key ingredient in BiDil is linked to a disease that afflicts a

disproportionate number of black women.

By Ricardo Alonso-Zaldivar, Times Staff Writer

Los Angeles Times, CA - July 2, 2005

http://www.latimes.com/news/nationworld/nation/la-na-

drug2jul02,0,5071914.story?coll=la-home-nation

 

WASHINGTON — An active ingredient in a new heart failure drug

tailored for African Americans can increase the risk of developing a

form of lupus, a debilitating disease that strikes black women in

disproportionately high numbers.

 

BiDil was officially launched Friday by Massachusetts-based NitroMed

Inc. as the first drug intended for use by patients in a particular

ethnic group. The Food and Drug Administration approved it June 23.

 

But one of its two key ingredients, a generic compound known as

hydralazine hydrochloride, long has been known to cause lupus in some

patients, according to FDA documents and interviews with doctors.

 

One in every 250 African American women has lupus, a painful immune

system disorder. Black women are three times more likely to get lupus

than white women. African Americans are also more likely than whites

to develop congestive heart failure, a weakening of the heart that

impairs its ability to pump blood. Heart failure death rates for

black women are nearly twice as high as those for white women.

 

Several cardiologists and lupus specialists say that the benefits of

BiDil appear to clearly outweigh its risks, since heart failure is

much more serious than lupus. But some of them question why FDA-

approved prescribing information for BiDil fails to recommend that

patients taking the drug get routine blood tests for lupus.

 

Such tests are recommended for patients taking the generic form of

the ingredient in BiDil, hydralazine, when it is prescribed

separately.

 

" I would have rather the product [literature] say that people should

have testing every six months, " said Dr. Jonathan Sackner-Bernstein,

director of clinical research in the heart failure center at North

Shore University Hospital on Long Island, N.Y. He was a member of the

FDA advisory panel that voted unanimously to recommend BiDil's

approval.

 

An FDA spokeswoman said the agency stood by its decision. She

suggested that decisions about testing were best left to individual

doctors.

 

For some patients, a lack of regular testing could prove hazardous,

another physician said.

 

Dr. Daniel J. Wallace, a lupus specialist at Cedars-Sinai Medical

Center in Los Angeles, said it could backfire on patients who

conscientiously take the BiDil but tend to shrug off joint pains,

fever and other flu-like symptoms that could indicate lupus.

 

" The problem is going to be the patient who takes the drug as

directed and doesn't make the connection, " Wallace said. " They'll

keep taking the medicine and won't call the doctor. " A blood test for

lupus antibodies costs about $30, he said.

 

Doctors should tell patients in advance of the lupus risk, said

Wallace, adding, " It's probably good medicine to be tested twice a

year. "

 

Indeed, the FDA-approved prescribing information for the generic form

of hydralazine says patients should be tested for lupus antibodies

before starting on the drug and " periodically " thereafter.

 

The prescribing information, also known as the drug label, serves as

a guide for doctors on how to use a medication and prevent unwanted

side effects.

 

However, prescribing information for BiDil calls for such testing

only if a doctor suspects that a patient already has symptoms of

lupus.

 

Sackner-Bernstein said tests recommended for patients taking generic

hydralazine " should be carried over " to BiDil.

 

Dr. Manuel Worcel, chief medical officer for drug maker NitroMed,

said BiDil patients would not be taking a high enough dose of

hydralazine to pose a significant risk.

 

" The drug is safe and effective for the treatment of heart failure,

and the benefits outweigh the potential side effects, " Worcel

said. " At the recommended doses, we have not seen a meaningful

incidence of lupus. "

 

As for routine lupus testing, " that is not what the FDA asked us to

do, " Worcel added. " This is not what we proactively would do. [but]

if a doctor wants to do that, I can understand that some would feel

it necessary to do that. "

 

The key clinical trial that led to BiDil's approval was carried out

with 1,050 African American patients. About half were given BiDil,

while the rest received standard treatment. Patients on BiDil had 43%

fewer heart failure deaths and a 39% drop in hospitalizations.

 

There was one confirmed case of lupus among the BiDil patients,

according to the FDA. But those who took BiDil were also four times

more likely to develop joint pain, a symptom often linked with lupus.

 

Patients taking part in the clinical trial were not routinely tested

for lupus antibodies, the company said.

 

The single lupus patient was a 40-year-old woman who developed

moderate symptoms, the FDA said. She was treated with an arthritis

drug, and her lupus cleared up after about seven weeks. She kept

taking BiDil throughout the lupus treatment.

 

Lupus that is brought on by taking a drug can usually be reversed by

stopping the medication, doctors say.

 

Dr. Clyde Yancy, one of the main investigators in BiDil clinical

trial, said physicians had options if their patients developed lupus.

For instance, they could reduce the dose of BiDil.

 

" If a patient has derived great benefit from [biDil] and the

complaints of lupus are modest, the doctor might elect to continue,

albeit at a lower dose, " said Yancy, a professor of medicine at the

University of Texas Southwestern Medical Center in Dallas.

 

" I don't have any sense that there will be no cases of lupus, " Yancy

added. " But to think there would be a significant number of cases —

that would be a totally unexpected circumstance. "

 

Copyright 2005 Los Angeles Times

 

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" Acute systemic lupus erythematosus syndrome from hydralazine

hydrochloride. "

HENN MJ, PARKIN TW, HARGRAVES MM, ODEL HM.

AMA Arch Intern Med.

1955 Jun;95(6):857-62.

PMID: 14375421 [PubMed - OLDMEDLINE for Pre1966]

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?

cmd=Retrieve & db=PubMed & list_uids=14375421 & dopt=Abstract

 

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