Re: Arava stays on US market: FDA formally denies Public Citizenpetition

[Guest guest]

This is a delightful result for Aventis, but not the consumer. It's not

just Public Citizen who has a serious concern about Arava.What these

" all clear " articles on the FDA Arava decision conveniently fail to

mention is that researchers at the Office of Drug Safety (part of the

FDA but distinct from the Arthritis Advisory Committee) came up with a

37-page report in which they justified their conclusion that Arava

should be withdrawn from the market. Curiously, they weren't allowed to

present their interpretation of the data at the final meeting! Aventis

and their lawyers and marketers were allowed to go on and on, but the

researchers were told to keep quiet.

Since insurance companies would rather pay for Arava than for Enbrel,

Remicade, Humira, or Kineret, Aventis has a nice little niche - those

patients who fail MTX and haven't moved up to biologics yet. All those

sales dollars will surely cover the cost of any lawsuits brought by the

patients who suffer severe liver injury or the loved ones of those who

die from liver failure.

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[ ] Arava stays on US market: FDA formally denies

Public Citizenpetition

Apr 2, 2004

Arava stays on US market: FDA formally denies Public Citizen petition

Washington DC - The cloud that has been hanging over leflunomide

(Arava®,

Aventis) in the US has finally cleared, with the FDA's formal denial of

the

petition mounted against the drug by the Public Citizen consumer group.

The

group had been campaigning to remove the drug from the US market because

of

safety concerns, mainly liver toxicity.

In a letter sent to the group last week, the FDA said that after a

thorough

evaluation of all the available data, it had concluded that the benefits

of

the drug outweigh its risks. " Arava's continued availability is

important

and justified, " the agency added.

The FDA stance mirrors the conclusions reached by its Arthritis Advisory

Committee at a meeting in March last year, at which it considered the

Public

Citizen petition. As reported at the time by rheumawire, the committee

members unanimously concluded that the benefit-to-risk profile for Arava

is

acceptable for its current indications. The committee also voted to

recommend approval of an expanded indication for improvement in physical

function in patients with rheumatoid arthritis, which was subsequently

approved by the FDA.

This latest stepthe letter the agency sent to the consumer group

represents

a formal denial of the petition and should mark the end of the saga.

Yesterday, the manufacturer, Aventis, welcomed the move. " We are pleased

that the FDA has denied the petition and that Arava will continue to be

available to patients in the US who need it, " said Dr Francois Nader

(senior

vice president, medical affairs, Aventis North America). " Arava is a

much-needed drug among the limited number of rheumatoid arthritis

therapies,

and it is an important option for physician choice and patient care. "