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The drugs regulators, those sentinels at the gate who ensure our safety from dangerous prescription drugs, can sometimes be slow to act

The drugs regulators, those sentinels at the gate who ensure our safety from dangerous prescription drugs, can sometimes be slow to act. It is now 18 months since we predicted the imminent withdrawal of Arava (leflunomide), the rheumatoid arthritis drug, after it had been linked to deaths from liver damage.

Yet, despite ever more health concerns - and legal claims for injury and death - surrounding Arava, the drug is still being prescribed daily.

In the UK, the drugs watchdogs have done nothing, even though the lead regulator, the European Agency for the Evaluation of Medicinal Products, issued an urgent warning about the drug over two years ago, and claimed that the drug was responsible for 12 deaths in Europe.

In the US, the Food and Drug Administration (FDA) has done as close to nothing as it's possible to do. In its customary flair for the dramatic, it added a warning to the prescribing information last November. It is now pointing out that Arava patients can suffer serious liver damage, which may be fatal. The new datasheet also reports that some patients have suffered severe infections, including sepsis, that have sometimes proved fatal.

Arava was approved in 1998 as an alternative to the standard arthritis drug methotrexate. But even though five methotrexate prescriptions are written for every one for Arava, the new drug has generated six times more reports of liver damage than methotrexate. The death rate is also 33 times higher than for methotrexate. It can also cause Stevens-Johnson syndrome, a serious systemic skin condition that is never seen with methotrexate.

Problems with Arava could be even worse than the statistics suggest. The drug stays in the body for a long time, and many serious cases of adverse effects have been reported six months after stopping therapy - making it difficult to point an accusing finger at Arava.


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