MORE BAD NEWS ABOUT REMICADE AND ENBREL Health Sciences Institute e-Alert January 29, 2002 **************************************************************** Please note: Information in the HSI e-Alerts should not be substituted for personal medical advice from a physician. **************************************************************** Dear Reader, Over the past few months, I've told you about some serious side effects from the prescription drugs Remicade and Enbrel, which are both used to treat rheumatoid arthritis (RA) and Crohn's disease. In the November 1st e-Alert, I told you how some doctors had been warned about Remicade's link to tuberculosis, infections, and complications in patients with congestive heart failure. Then on January 2nd, I wrote about Enbrel's association with central nervous system disorders like MS and Guillian-Barre syndrome. Unfortunately, the news gets even worse. Now, research is showing that BOTH drugs may actually cause nerve damage that can lead to MS and other central nervous system (CNS) disorders. And, according to a Reuters Health article, even mainstream authorities are starting to question how these drugs are prescribed. ---------------------------------------------------------------- Drugs can cause a lot of damage in a short period of time ---------------------------------------------------------------- Doctors at Georgetown University Medical Center in Washington, D.C., initiated the research after they encountered a rheumatoid arthritis patient who was suddenly experiencing confusion and having difficulty walking. According to the Reuters article, a brain biopsy revealed demyelation, or damage to the protective sheaths that coat nerve fibers. Searching for an explanation, the doctors noted that the patient had been taking Enbrel for four months. When they searched the FDA Adverse Reports database, they found 19 other reports of patients taking Enbrel or Remicade who had developed symptoms indicative of nerve damage. Eighteen of them had brain MRI's that showed demyelination. And on average, the patients had been taking the drugs for only five months. Fortunately all of the patients saw their symptoms at least partially recede once they stopped taking the drugs. But some of them could have been spared the experience all together - if their doctors had been aware that they shouldn't have been taking the drugs because of pre-existing conditions. You see, at least four of the 20 patients were known to have MS or a similar CNS syndrome BEFORE they were prescribed the drug. And according to the Reuters Health article, the manufacturers of Enbrel and Remicade have known about this side effect for over a year, and a warning appears on the drugs' packaging and on the companies' web sites. ---------------------------------------------------------------- Is it safe for anyone to take these drugs? ---------------------------------------------------------------- The Georgetown researchers concluded "Consideration should be given to avoiding anti-TNFalpha therapy [the drug class that includes Enbrel and Remicade] in patients with pre-existing multiple sclerosis and to discontinuing...therapy immediately when new neurologic signs and symptoms occur..." That seems like the understatement of the year. And I'm not the only one who thinks so. In the Reuters article, Dr. John H. Klippel, medical director of the Arthritis Foundation, states a similar view. Asked to react to the study's conclusion, Klippel said, "I would be a little more emphatic. Instead of giving 'consideration to avoiding,' I think the medical community would be of the view that these drugs should not be used in people with known demyelinating diseases like multiple sclerosis." I agree with Klippel. But perhaps I'd be even more emphatic. Only four of the 20 known patients who suffered neurological damage had pre-existing CNS conditions like MS. Even if their doctors had known better, that still leaves at least 16 people who now have permanent damage done to the nerves in their brain - and possibly, an increased risk of developing MS or a similar condition in the future. And who's to say what the real numbers are; as the Georgetown researchers wrote, "...underreporting of adverse events occurs." (There's another entry for understatement of the year.) ---------------------------------------------------------------- Adding up the risks - and considering alternatives ---------------------------------------------------------------- To be fair, tens of thousands of people have taken Enbrel and Remicade since their introduction. At this point, we know of only 20 cases where the drugs were associated with demyelinating damage. Anyway you look at it, the risk for the average patient is probably quite small. But that's the same thing they said about Remicade's association with infections, TB, and congestive heart failure, and Enbrel's earlier association with demyelination. When you start combining all these small risks, sooner or later they get to be too big. If you take Enbrel or Remicade, discuss these risks with your doctor. Remember, everyone should have a TB test before using these drugs, and people with congestive heart failure or conditions like MS should NOT take them. And remember that these potentially dangerous prescription drugs are not your only option for treating RA and Crohn's. As I mentioned in the November 1st e-Alert, we've written about the pancreatic enzyme supplement Wobenzyme (February 2001) for RA, and the therapeutic yeast saccharomyces boulardi (SB) (October 2000) for Crohn's. Here at HSI, we'll continue to search for more natural remedies to help you fight RA and Crohn's. And we'll keep bringing you the latest information on the side effects of prescription drugs that your doctor may not know about. Having all the facts in front of you is the only way you can make an informed decision about your treatment. To Your Good Health, Jenny Thompson Health Sciences Institute