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Arava - An Improved Drug? |
| A recent study has found that only 15% of new drugs approved in
the last decade were novel chemicals that the FDA deemed a significant
improvement over older drugs. It is not just Arava liver
failure that is the concern, but of lymphoma, hypertension, and
other problems have also been reported. |
Dangers of Arava
Arava is dangerous, not just because of the life threatening and serious
Arava
side effects associated to the rheumatoid arthritis drug, but
because the inability to predicts which patients are at risk and the
short amount of time it takes for the drug to affect someone. In six
months Arava patients have suffered from the dangerous side
effects associated to the drug and even when discontinuing the
rheumatoid arthritis drug treatment patients are still at risk because
it remains within the body as it slowly dissipates. Rheumatoid
arthritis affects around 2 million Americans, typically affecting
adults between the ages of 25-50.
If you have taken Arava and would like more information due to
the serious Arava
side effects that you have, or still are, experiencing, please
CONTACT
US to learn more.
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About
Arava
Arava is especially dangerous due to the amount of time the drug
remains in the body after discontinuing its use, so the risk of
harming an unborn baby can still be great. click
here to read more »
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Arava - Liver Failure
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| More than two million Americans are affected
by rheumatoid arthritis (RA), normally first affecting individuals
between the ages of 25-30 when their immune system begins to attack
their cartilage. In the past, methotrexate was used to treat rheumatoid
arthritis patients until the FDA
approved Arava (leflunomide), manufactured by Aventis Pharmaceuticals
in September 1998. Since then, the FDA has received 130 reports of
severe Arava
liver toxicity that includes 56 hospitalizations and 12 deaths.
The Public Citizen consumer group filed a petition on March 28, 2002
for the FDA to immediately ban Arava from the market. |
Public Citizen is proactive in questioning
FDA action regarding pharmaceutical drugs and questions why Arava
was approved by the FDA simply to provide different options for patients
but showed no signs of working better than already available treatments
such as methotrexate. In addition, Arava has been found to have six
times more FDA reports of
liver damage than methotrexate. The two rheumatoid arthritis drugs
work equally well, so Public Citizen wants Arava's sales banned. The
FDA is still reviewing Public Citizen's petition. |
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If
you have taken Arava and would like more information due to the
serious Arava
side effects that you have, or still are, experiencing, please
contact
us to learn more.
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Message from Public
Citizen
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| Public Citizen's Dr. Sidney Wolfe said Arava should never
have been approved because the drug's studies showed it contributed
to elevated liver enzymes, which is normally a sign of damage
to the organs. |
Arava
Side Effects
Arava was originally considered
to be a safer alternative to methotrexate,
the commonly used rheumatoid arthritis drug used
prior to Arava's approval. Methotrexate
has been known for its severe side effects,
but
Arava has now been shown to have a death rate
of 33 times higher than methotrexate patients and has had six times
more reports of liver damage. These Arava figures do not even take
in consideration the fact that methotrexate has been prescribed
5.5 times more than Arava. More than 200,000 rheumatoid arthritis
patients have used Arava since the drug was released. Arava did
not receive approval because of its superiority in treating rheumatoid
arthritis over methotrexate but simply because the FDA wanted RA
patients to have more treatment options. click
here to read more »
Arava linked to 12 deaths
Public Citizen filed a petition to the FDA asking the agency to
review the unforeseen deaths and illnesses that have been associated
to Arava on March 28, 2002. The 12 deaths that have been linked
to Arava are from liver
failure, as well as dozens of other serious illnesses. Some
doctors claimed they would continue to prescribe the prescription
drug intended to treat the signs and symptoms
of rheumatoid arthritis (RA) but alongside blood tests to monitor
patients' liver function. Other doctors supports Public Citizen's
petition, including the former scientific adviser to the FDA and
current director of the University of Arizona Arthritis Center Dr.
David Yocum, in particular because of the rapid deaths of the 12
Arava patients.
The first warning that Arava was linked to liver
failure was in February 2001 when the European Agency for the
Evaluation of Medical Products issued a warning to doctors and patients.
The agency cited nine deaths that had occurred from liver failure
in Arava patients. Arava's manufacturer, Aventis Pharmaceuticals,
issued letters to physicians following the agency's warning throughout
Europe but did not warn the U.S. physicians and patients for another
two months.
Arava
was developed as an alternate medication for rheumatoid arthritis.
Methotrexate had been the predominant rheumatoid arthritis medication
until the approval of Arava. The FDA approved Arava in 1998 but
said it was no better than methotrexate but Arava would allow patients
to have options. Dr. Yocum has worked on arthritis drug development
for almost 20 years and has never supported taking a drug off the
market until Arava.
If you have taken Arava and would like more information due to
the serious Arava side effects that you have, or still are, experiencing,
please
CONTACT
US to learn more.
Arava
In the News
-March 28, 2002
Rheumatoid arthritis drug Arava may cause liver damage.
Public Citizen wants rheumatoid arthritis drug Arava banned because
of the dozens of serious liver injuries and 12 deaths linked to
the drug's use. After the 1998 FDA approval, the FDA did state that
Arava worked no better than the older drug, competitor methotrexate,
but it know provided patients with different options. The FDA has
now received at least 130 reports of severe liver toxicity linked
to Arava use, and this includes 56 hospitalizations and 12 deaths.
The FDA has six times more reports of liver damage among Arava users
than methotrexate users, despite methotrexate being prescribed 5.5
times more than Arava. (Yahoo, 3-28-02) click
here for more news »
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Arava Violations
October 23, 1998
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Arava (leflunomide) manufacturer was sent a letter from the Department
of Health and Human Services notifying them that The Division of
Drug Marketing, Advertising and Communications reviewed their submissions
and found they had violated the Federal Food, Drug, and Cosmetic
Act. The FDA had identified violations in the following Arava materials:
- New Release (ID#98190106/
2934P8)
- Media Alert (ID#98190105/
2933P8)
- Dear Editor/Producer
Letter (ID#98190101/
2930P8)
- Video with Script (ID#98181101/
2887P8)
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| These FDA violations of Arava materials
led the Division of Drug Marketing, Advertising and Communications
to recommend that Arava manufacturer take the following actions:
1. Immediately discontinue the use of this, and all
other promotional materials for this product that contain
the same or similar violations.
2. Provide to DDMAC, in writing, HMR's intent to comply
with #1 above. Your response should be received by November
6, 1998.
3. This response should include a list of all similarly
violative promotional materials and HMR's method for discontinuing
their use.
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