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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
Arava (leflunomide) is an anti-inflammatory medicine that is used
to treat the signs and symptoms of rheumatoid arthritis. Arava is
in the FDA pregnancy category X because of the increased risk of
birth defects and fetal death while taking the rheumatoid arthritis
drug. The drug should not be taken if the patient is or is planning
on becoming pregnant. 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. It is not known whether or not
Arava passes through breast milk, so safety precautions should be
taken.
Who should not take Arava (leflunomide)?
There is alternate rheumatoid arthritis medication that does not
carry the same risk that Arava has been linked to. When the FDA
approved Arava they did not find that the drug produced better results,
rather the entrance of the RA drug would provide patients with more
options. Methotrexate has been identified to have six times less
occurrence of reported
liver damage than Arava, even despite methotrexate being prescribed
5.5 times more. Sidney Wolfe, of the Public Citizen consumer advocacy
group believes that "when there are other treatments that are
more effective and don't endanger patients as much as this drug,
there is absolutely no reason for the FDA to keep Arava on the market."
The consumer advocacy group petitioned to the FDA for the immediate
ban of Arava on March 28, 2001.
Before taking Arava (leflunomide) it is advised to tell your doctor
if you have:
- liver disease, history of hepatitis
- history of a lot of alcohol use
- kidney disease
- have recently received a live vaccine
- chronic infection
- immune system disease
- poor bone marrow function
In addition, if any of the following drugs are being used, it is
also advised to seek medical opinion concerning Arava because combining
certain drugs may increase risk of deadly side effects.
- cholestyramine (Questran, Prevalite, LoCholest)
- methotrexate (Rheumatrex)
- rifampin (Rifadin, Rimactane)
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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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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