FDA Gives Approval to New Relief for Arthritis Sufferers

Arava, a new drug for rheumatoid arthritis that helps relieve symptoms but is a far cry from a cure, won approval Friday from the Food and Drug Administration.

The FDA warned that Arava is also too dangerous to use during pregnancy--bad news for many of the estimated 2 million rheumatoid arthritis sufferers in the U.S., most of whom are women.

Nonetheless, the agency was encouraged by studies that indicate Arava can help prevent some of the damage that rheumatoid arthritis causes to joints and sped the drug through its approval process.

Arava, which is made by Hoechst Marion Roussel, can be used as an alternative to the standard therapy, methotrexate.

Dr. John Hyde, acting deputy director for the FDA division responsible for the drug’s approval, said it will be carefully labeled.

Studies have shown it can cause birth defects in animals, so Arava should not be used by pregnant women, he said. It also can cause liver damage, diarrhea and hair loss. Doctors will be told to carefully monitor the liver enzymes of patients taking Arava to check for signs of damage.

“There’s certainly reason to be prudent with it,” Hyde said in a telephone interview. “It has a very long half-life, so if someone is taking the drug, even after they stop, it will hang around awhile.” The drug can linger in a person’s system for six months.

A cholesterol-lowering drug can be used to take Arava out of the system of a woman who wants to get pregnant or who finds out she is pregnant, Hyde added. Also, doctors say studying Arava has brought new understanding in how to treat rheumatoid arthritis--that patients need powerful therapy in the disease’s earliest stages to help protect joints from irreparable damage.

The new studies suggest that taking either methotrexate or Arava is important for patients in the first one to three years of the disease--a window of time before they feel too bad but when their joints are undergoing a silent, serious attack, said Dr. Michael Schiff of the Denver Arthritis Center.

“That doesn’t do anything more than make patients feel better,” said Schiff, who helped research Arava. “We now realize you need to do more than that, and can do more.’

Rheumatoid arthritis is not the type that plagues the elderly as their joints essentially wear out. Instead, it is an autoimmune disease: The immune system goes awry and attacks patients’ own cartilage. It typically strikes between ages 25 and 50.

Arava, which is known chemically as leflunomide, works by blocking the overproduction of immune cells responsible for most arthritis-caused inflammation.