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[log in to unmask] ----- Original Message ----- From: "HSI Research Team" <[log in to unmask]> To: "MS. BERNA MCCARTHY" <[log in to unmask]> Sent: Thursday, November 01, 2001 5:00 PM Subject: Common drug for RA and Crohns carries significant risks > COMMON DRUG FOR RA AND CROHN'S CARRIES SIGNIFICANT RISKS > > Health Sciences Institute e-Alert > > November 1st, 2001 > > ********************************************************* > > Dear Reader, > > The two letters are eerily similar. Both bear the circular > logo of the pharmaceutical company, Centocor. Both carry > dates in October 2001. Both are addressed to "Dear > Healthcare Professional," followed by a heading in large, > bold, capital letters: IMPORTANT DRUG WARNING. And there's > one more important commonality: both contain information > about serious risk from Centocor's drug REMICADE ®, a > medication widely used to treat Crohn's disease and > rheumatoid arthritis (RA). > > The first letter, dated October 5, warns doctors that > tuberculosis and "other opportunistic infections" have been > observed in patients taking Remicade. At least 84 cases of > TB have been documented, and 14 of those people have died > as a result. > > But then, less than two weeks later, came the second > letter. It makes you wonder - is this just a bad > coincidence or do we not know enough about what this drug > can do? > > Dated October 18, the second letter cautions doctors > against prescribing Remicade to patients with congestive > heart failure (CHF). In clinical trials, scientists found > that patients' moderate to severe CHF symptoms worsened > while taking Remicade - and at least seven people died from > CHF while participating in a Remicade clinical trial. > > Your doctor may or may not have received both of these > letters in October. And if you take Remicade, you may have > already been informed. But if you or someone you love > suffers from Crohn's or RA, you need to understand these > results right NOW. > > REMICADE ® is the brand name for the prescription drug > infliximab, which works by inhibiting the body's natural > immune response. Specifically, it binds an immune system > cytokine called tumor necrosis factor (TNF). Inflammation > is a common side effect of TNF activity (and other immune > responses as well). > > Both Crohn's disease and rheumatoid arthritis (RA) are > characterized by inflammation - the former in the > gastrointestinal tract, and the latter throughout the > body's joints. So drugs like Remicade were designed to > treat RA and Crohn's by blocking the TNF activity that may > contribute to the inflammation. > > Remicade was first approved in 1998. It was indicated for > short-term use in treating patients with Crohn's that had > not responded to other kinds of therapy. It was also > approved for treating RA in combination with methotrexate, > for patients who had not seen relief from methotrexate > alone. (Methotrexate, also known as amethopterin or by the > brand names Folex and Rheumatrex, is a prescription drug > often used to treat RA. It comes with its own list of > serious side effects, including problems with the kidneys, > stomach, and liver, loss of hair, and increased risk of > blood diseases like leukemia.) > > Because of its immunosuppressive action, authorities knew > that Remicade could increase the chances of developing > infections. So the October 5 warning about the risks of > tuberculosis, histoplasmosis, listeriosis, and fungal > pneumonia, was not a complete surprise. The new > communication recommends that doctors test patients for > latent TB infection before prescribing Remicade, and that > they carefully consider risks in regions where > histoplasmosis typically occurs. (Histoplasmosis is caused > by the bacterium H. capsulatum, which is contracted through > contact with soil or materials contaminated with bat or > bird droppings. According to the Centers for Disease > Control and Prevention, it is most prevalent in the eastern > and central United States.) > > But the second warning arose from Centocor's own research. > Animal studies had suggested that Remicade's TNF-binding > action might also be an effective therapy against > congestive heart failure (CHF). This deadly condition > results when the heart cannot pump efficiently, usually as > the result of damage from a heart attack or years of > chronic hypertension or heart disease. Fluid accumulates in > the lungs and leads to breathing difficulties and leg and > ankle swelling. Almost five million Americans have > congestive heart failure, and most of them die from it > eventually. > > So Centocor recruited a total of 150 patients with moderate > to severe congestive heart failure for the trial. A control > group of 49 people took a placebo, while 101 received > Remicade, either in a 5 mg/kg or 10 mg/kg dosage. All of > the drugs were administered intravenously, and the > treatments lasted for six weeks. > > During the study, seven of the 101 patients in the Remicade > group died of congestive heart failure. (None of the > patients in the placebo group died during the study.) A > 7 percent death rate in 6 weeks was significant enough for > Remicade's manufacturer to halt the study and report the > findings to the FDA. > > The result was the October 18 letter, which was mailed to > 35,000 doctors who the FDA determined were "likely to > treat" patients who may be at risk. > > We can only hope that the information reached all the > appropriate doctors - and all the appropriate patients. > Centocor says it is working with the FDA to develop updated > prescribing information and packaging for the drug. (Maybe > they were able to catch it before it went off to the > printer - the boxed warning notice had just been revised to > reflect the increased risk of tuberculosis and other > infections.) > > Here's what you can do: > > * If you take Remicade, discuss these risks with your > doctor. Ask for a TB test, and ask about the risk of > histoplasmosis in your area. If you have congestive heart > failure as well, ask about other alternatives to Remicade. > > * Pass this information along to anyone you know who might > already be taking Remicade, and to anyone who suffers with > RA or Crohn's and might be prescribed the drug in the > future. > > But perhaps most importantly, remember that prescription > drugs and their potentially toxic side effects are not the > only option for patients with Crohn's and RA. At HSI, we've > written extensively about alternative therapies for both RA > and Crohn's disease. In February 2001 Member's Alert > newsletter, we told you about an oral supplement from > Germany called Wobenzyme, a blend of pancreatic enzymes > that clears the body of the excess antibodies that > characterize an autoimmune disease. Studies have shown that > Wobenzyme can prevent RA flare-ups and help lower levels of > these antibodies, called circulating immune complexes, or > CICs. In October 2000, we wrote about the therapeutic yeast > saccharomyces boulardii (SB), which nourishes and protects > the healthy intestinal flora. At least two clinical studies > have shown that SB can significantly reduce Crohn's > symptoms compared to placebo. > > Centocor reminds us that approximately 170,000 patients > have been treated with Remicade worldwide since it was > introduced. And between these two incidents, only 21 people > have died - 14 from infections and seven from congestive > heart failure. The "Dear Doctor" letter also notes that > "most" of the people who died of TB were taking other > immunosuppressive drugs while taking Remicade. It's true > that the risks are small - but that's no comfort to the > families of those 21 people. Before you start - or continue > - to take any prescription medication, make sure you have > all the information and know all the risks. 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