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

[Guest guest]

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. "

[Guest guest]

I would still be raving about Arava if I hadn't had to stop it because

of a low white blood cell count. It really helped my pain and

inflammation. Now that I'm off of Arava, my white blood cell count is

still low, so I wonder if Arava even lowered it or if it was something

else, since it still won't go up. Sue

On Friday, April 2, 2004, at 07:25 PM, a wrote:

> 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.