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Arava: the 'sixth drug' that may soon
be under fire
Arava: the 'sixth drug' that may soon be under fire
At a recent hearing into the
Vioxx affair, the FDA's Dr
David Graham named five drugs that he considers too dangerous to be on the
market. However, in his testimony, Dr Graham also cited Sanofi-Aventis' Arava
as a drug he has recommended be withdrawn. Unlike the other five drugs, Arava
has largely escaped the media spotlight, but there may yet be some tough
questions asked about its safety.
Arava: the 'sixth drug' that may soon be under fire
Arava: the 'sixth drug' that may soon be
under fire
(Date of publication 3 December 2004)
At a recent
hearing into the Vioxx
affair, the FDA's Dr David Graham named five drugs that he considers too
dangerous to be on the market. However, in his testimony, Dr Graham also cited
Sanofi-Aventis' Arava as a drug he has recommended be withdrawn. Unlike the
other five drugs, Arava has largely escaped the media spotlight, but there may
yet be some tough questions asked about its safety.
Arava
(leflunomide) is marketed by Aventis, part of Sanofi-Aventis, and recorded
sales of $288 million in 2003. It is an oral disease modifying treatment for
rheumatoid
arthritis (RA), and may be next in the firing line for increased regulatory
scrutiny, in the wake of the withdrawal of Vioxx (rofecoxib).
Dr
Graham, the Associate Director for Science and Medicine in the FDA's Office of
Drug Safety, cited the now familiar list of five drugs that he considers should
be removed from the market, in response to open questioning from the Senate
Finance committee. Much media attention has been given to these five drugs,
which include Crestor
(rosuvastatin), Serevent (salmeterol xinafoate), Accutane (isotretinoin),
Meridia (sibutramine
hydrochloride monohydrate) and Bextra (valdecoxib). Some of the companies
involved immediately countered Dr Graham's statement, reassuring the public of
the safety of these treatments, but the mention of Arava appears to have gone
largely unnoticed.
Regulatory approval
In his prepared
testimony to the committee Dr Graham related his past record from 20 years at
the FDA, where he has recommended a total of 12 drugs for withdrawal from the
market, only two of which remain on the market today. One of these is Accutane,
mentioned in the list above, and the other was Arava. Dr Graham stated that he
and another, unnamed, FDA colleague believe that it "causes an unacceptably
high risk of acute liver failure and death".
On November 23, 2004 the
FDA announced the strengthening of the risk minimization action plan (RiskMAP)
for Accutane to reduce the risk of birth defects associated with fetal exposure
to it. Steps to monitor the use of other drugs on Dr Graham's list, including
Arava, which is targeted at a similar market to Vioxx, may be required by the
FDA.
Arava was approved in the US in 1998, 2000 in the EU and more
recently in April 2003 in Japan. However in February 2004 Sanofi-Aventis
reported that the deaths of five Japanese RA patients may be linked to Arava
and it recommended Arava not be used on patients with respiratory problems.
Arava had previously been linked to at least 12 other deaths due to liver
failures.
Safety concerns
However, the FDA cleared
Arava over liver side effects in April 2004 when it denied a Public Citizen
petition. This petition was backed by Dr David Yocum, director of the
University of Arizona Arthritis Center, who previously served on the FDA's
arthritis drugs advisory committee and was its chairman for two years until
late 2001. The FDA concluded that the benefit to risk ratio for Arava was
acceptable, but the disagreement with this fact by such an experienced and
prominent researcher as Dr Graham indicates a certain conflict within the
organization on this issue.
Arava is marketed as an alternative option
to methotrexate, an established treatment used in severe RA, which has some
serious side effects. The option appears to have been a dangerous one as
reports have emerged that Arava patients may have a higher death rate than
methotrexate patients. The parallel with Vioxx, marketed as a less dangerous
alternative to traditional NSAIDs, is clear.
If this information is
reassessed in light of the Vioxx inquiries currently
taking place, Sanofi-Aventis may find itself in a similar position to its
fellow pharma giant Merck & Co, not to mention the likes of Pfizer and GSK,
which are also looking on anxiously as concern mounts over the safety of
products such as Bextra and Serevent. Legal action is already underway against
Arava in the US, with lawyers advertising for clients to engage in class action
lawsuits. Despite passing almost unnoticed in the wider media reporting of Dr
Graham's 'hit list', there seems to be little doubt that Sanofi-Aventis will
shortly be forced to defend the safety of Arava: in the present post-Vioxx
climate, it appears that this drug may not survive the scrutiny.
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