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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 Patient Action
Reporting Arava Adverse Effects to the FDA
MedWatch is the FDA's program that allows consumer to report serious
reactions and problems with medical products. So far, there have
been at least 130 cases of severe
liver problems (hepatoxicity) and 22 deaths since Arava's arrival
to the market in 1998. It is estimated that there is a 10-100 fold
of underreporting that occurs with a drug's adverse
effects. Not reporting serious adverse Arava side effects can
result in continued instances of death and serious health conditions
that may have been prevented. Since MedWatch is a voluntary reporting
system, many healthcare providers, as well as individuals, fail
to give this information to the FDA. If you, or a family member,
have suffered the serious and potentially deadly Arava side effects,
it is encouraged for you to
report it, and there are several different reporting options
available.
»
Your health care provider or the FDA online reporting form
that allows consumers to notify the FDA of important and useful
information regarding patient safety. 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. You may be eligible to file a claim for the
injuries and serious Arava side effects you have sustained as a
result of the rheumatoid arthritis drug that has been linked to
cases of liver failure and other conditions.
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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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