Novartis' Prexige Arthritis Drug Withdrawn from UK
British drug regulators have demanded the withdrawal from the market of Novartis' arthritis drug Prexige. The decision was made in light of mounting evidence linking the drug to liver damage. In the past two years, and globally speaking, Prexige has been associated with 20 instances in which patients livers have been severely damaged. Two of these resulted in death, while three involved a liver transplant.
The Medicines and Healthcare products Regulatory Agency cites 23 cases in Britain involving Prexige's effect on the liver since March 2006. These, however, were not deemed severe, and did not result in either a transplant or a fatality.
However, viewing these statistics alongside the international data, the decision was made by the agency to suspend Prexige's licence.
Novartis: 5,000 UK Prexige Patients Should Contact GP
Novartis itself has requested that the 5,000 or so patients in the UK taking the drug liaise with their doctors to arrange the prescription of other therapies.
Prexige's fall from grace is the most recent problem to strike a drug group that, at one point, was viewed as offering a safe relief from arthritic pain. The most infamous example is Merck's Vioxx - withdrawn by its makers three years ago after it was associated with cardiovascular complications.
In recent days, Merck agreed to the payment of compensation totalling $4.85 billion in respect of injuries that claimants said were Vioxx-associated.
The first use of Prexige occurred 28 months ago in Brazil. Since then, it is thought to have been taken by 8.5 million patients located in 30 countries around the world.
The US market never accepted it, with the US Food and Drug Administration requesting additional evidence that showed it to be superior over existing arthritis drugs.
Risk/ Benefit Assessment to Follow Arthritis Drug Suspension
Following the suspension, next on the agenda, said the British medicinal agency, would come an assessment across Europe of both the risk factors and the positive elements of Prexige. This, it added, was based on data highlighting how, even at the 100mg level of dose, the drug was capable of producing side effects.
Both Prexige and Vioxx belong to a drug class known as COX2 inhibitors. In their absence, Arcoxia and Celebrex (made by Merck and Pfizer respectively) are the only drugs within this classification that remain on the UK market.
Source - Pharmaceutical International's Health Reporter
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