Studies of a class of rheumatoid arthritis drugs on the market revealed cases of lymphoma, a blood cancer, in treated patients. Now, as part of a safety review, the U.S. Food and Drug Administration (FDA) wants an advisory panel’s advice on how to best study the issue and express a warning on the drugs’ labels.

The drugs, which are used to treat advanced cases of the disease, include Abbott Laboratories’ Humira, Johnson & Johnson's Remicade and Amgen’s Enbrel. The medicines are injected and bioengineered to block a protein called tumor necrosis factor, or TNF, which is linked to the inflammation that causes painful, inflamed joints in people with rheumatoid arthritis.

However, although the TNF molecule causes discomfort in people with rheumatoid arthritis, it also helps fight infection and possibly cancer.

Along with lymphoma risk, the medications have already been linked to other serious side effects, such as higher risks of infection and tuberculosis.

According to the panel, of 8,000 patients treated with the drugs, 24 developed lymphoma as compared with none of the patients taking the placebo.

However, previous studies have also found an increased risk of lymphoma among patients with rheumatoid arthritis, which makes it difficult to determine whether the drugs or the disease are related to the occurrences of lymphoma.

Humira's label states that in clinical trials 10 lymphoma cases were observed. It also says the role of this class of drugs in the development of malignancies is unknown.

Remicade's label also includes clinical trial data regarding malignancies and says that the data is insufficient to determine whether the drug plays a role.

Analysts expect the FDA panel to recommend further studies and possibly enhance safety precautions for this class of drugs. The FDA is not required to accept the panel’s advice, though it typically does. Analysts did not think the warnings would alter the drugs’ combined 2003 sales, which they estimated would reach over $3 billion.

Meanwhile, the panel is also reassessing the safety of another rheumatoid arthritis drug, Arava, because of increasing reports of liver failure among treated patients.

Rheumatoid arthritis affects mostly women, often starting between the ages of 25 and 50 years. The disease upsets the immune system, causing it to attack the body’s cartilage and resulting in pain and swelling and eventually destroying joints.

Seattle Times March 5, 2003

Dr. Mercola's Comments:

I warned about the dangers of Remicade when it was first introduced about three years ago. The drug costs over $10,000 a year, while Enbrel can cost up to twice as much. And we wonder why America is having a health care crisis where 40 percent of the population can’t afford health care. Let’s get real; our country can only support the drug companies for so long before this support collapses the entire economy. Corporate America simply cannot afford this insanity much longer without surrendering its lead to foreign countries that aren’t handicapped with these ridiculous drug premiums that they have to subsidize through their insurance policies. This abuse is particularly tragic in the case of rheumatoid arthritis (RA). There are a number of very effective therapies that I have used to help thousands of patients with RA go into remission--without expensive drugs like Remicade. For the last 13 years, I have used a revision of Dr. Brown's antibiotic protocol to treat RA. However, when the resources listed below are followed, mild cases of RA do not even require the antibiotics. First, following the nutrition plan is profoundly helpful for normalizing the immune system. Additionally, omega-3 fats, found in fish oil and cod liver oil, are remarkably beneficial to health. It is necessary to use a quality source of fish oil and cod liver oil to ensure that toxins and other impurities have been removed from the oil. If you are unable to find one locally, I offer Carlson’s brand fish oil and cod liver oil on this site, as I have found it to be of superior quality. Aside from nutrition, NST is another option to explore. NST is a structural realignment technique that seems to be exceptionally useful for putting the disease in remission. If you are a health care practitioner you will want to consider attending the important NST training in Chicago this spring. Another useful technique is EFT. This technique has also resulted in profound improvements in patients with RA, as most people seem to have some sort of precipitating emotional trauma. The emotional trauma weakens their immune system, which is what allows the infection to get in. Related Articles: Illegal Methods Used for Marketing Arthritis Drug Arthritis Drug May Worsen Conge Heart Failure Anti-Inflammatory Drug Linked to TB Arthritis Drugs Have New Warnings, but Will the Doctors Listen??